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Focus Graphite's (TSX VENTURE:FMS)(OTCQX:FCSMF) Lac Knife Project's Benchmark Feasibility Study Reports
Highlights: $383 Million NPV; 30.1% IRR; Operating Costs of $441 Per Tonne
OTTAWA, ONTARIO--(Marketwired - June 25, 2014) - Focus Graphite Inc. (TSX VENTURE:FMS)(OTCQX:FCSMF)(FRANKFURT:FKC) ("Focus" or the "Company") is pleased to report the results of its Feasibility Study ("FS") for the Lac Knife Project performed by Met-Chem Canada Inc.
The study was based on a 25-year mine life that produced a Pre-tax Net Present Value ("NPV") of $383 million calculated at a discounted cash flow ("DCF") rate of 8% Pre-tax, the financial model has an Internal Rate of Return ("IRR") of 30.1% and a capital payback period of 3.0 years.
The after tax financial model has an NPV of $224 million calculated at a DCF rate of 8%, and with an IRR of 24.1% and a capital payback of 3.2 years. A National Instrument 43-101 technical FS report will be filed on SEDAR within 45 days of this news release.
"Lac Knife is a remarkable property by any Canadian or international standard," Gary Economo, Focus' Chief Executive Officer said. "As we have already demonstrated, Lac Knife provides us, and our shareholders, with a significant advantage. And that is: The ability to meet our customers' needs for quality products at competitive prices."
Don Baxter, Focus's President and COO said: "We are very pleased to have reached this significant milestone in the development of the Lac Knife Project. With the Feasibility Study in hand, an offtake with an end-user signed as well as battery tested spherical graphite, Focus has positioned itself as a leader in the graphite space, with no other company having reached this level of development."
Table 1
Lac Knife Feasibility Results (Pre-Tax) Base Case 2016 Forecast Units
Average Price / Tonne of Concentrate: $1,713 $2,256 US$
Internal Rate of Return (IRR) 30.1 41.8 %
Net Present Value @ 6% Discounted Cash Flow 510 809 $ million
Net Present Value @ 8% Discounted Cash Flow 383 624 $ million
Net Present Value @ 10% Discounted Cash Flow 291 488 $ million
Payback Period 3.0 2.1 Years
Lac Knife Feasibility Results (After-Tax) Base Case 2016 Forecast Units
Internal Rate of Return (IRR) 24.1 32.8 %
Net Present Value @ 6% Discounted Cash Flow 304 476 $ million
Net Present Value @ 8% Discounted Cash Flow 224 364 $ million
Net Present Value @ 10% Discounted Cash Flow 165 280 $ million
Payback Period 3.2 2.4 Years
All monetary values are in Canadian Dollars ("CDN") except where specified otherwise
Results from the FS indicate that the Lac Knife Project is viable economically with a Base Case scenario that includes a concentrator production line rate of 44,300 tonnes of concentrate annually at an average mill feed rate of 323,670 tonnes per year of Mineral Reserves over a 25-year mine life. A concentrator availability of 93% was used for the study. The additional Measured, Indicated, and Inferred Resources will continue to be evaluated to develop the mid and long term growth profile for the Company.
Highlights:
•Reduced operating costs from $458 per tonne of concentrate to $441 per tonne within close range of the Updated PEA study released November 7th, 2013.
•Mining costs are 126.95 $/t of concentrate ($17.85 per tonne of ore) with the major component associated contract mining costs. Contract mining versus lower cost owner mining can be revisited with further evaluation of mine equipment leasing and associated owner's costs.
•Processing costs for the concentrator are, on average over the life of mine $239.37 per tonne of concentrate produced, based on yearly average processing costs of $33.66 per tonne of ore processed. The low cost hydroelectric power supplied by Hydro Quebec contributes to overall low production costs.
•Detailed engineering is planned to start in 2014 and further analysis of each of these cost components will continue during the detailed engineering stage.
•Life of Mine Plan resulted in an overall average strip ratio of 1.8 to 1 for 25 years.
•Average prices used in the financial model do not include value added products that can be produced using the typically lower valued finer natural flake graphite. These finer graphite concentrates can be further processed into value added products for the Lithium Ion battery market because of their high carbon content of 98% carbon and realize a higher margin for a reasonable capital investment and operating cost over and above those outlined in this release. Based on these results it has become an important objective to outline the scope of this secondary transformation project for electrifying transportation and for use by other lithium battery end users.
Today, the prices for the Lac Knife graphite concentrates average US$1,713 per tonne based on the size distribution and high carbon grade. Also included in the table above are the results using forecasted prices for 2016 where the average price for the same concentrates is estimated to increase to US$2,256 per tonne. These prices are estimated by Industrial Minerals Data of the UK, who are recognized in this field as an independent source of accurate, detailed information for the natural flake graphite market.
Met-Chem's financial model does not include potential value-added, purified, spheronized, and coated battery-grade graphite in its financial and operational calculations.
The exchange rate used is $0.91 US Dollars per Canadian Dollar. Table 1 provides the Net Present Values calculated at various discounted cash flow rates for the Base Case production scenario of 44,300 tonnes of graphite concentrate produced annually. The financial analysis in the FS study used the 24 month price of US$1,713 per tonne that is a weighted average for the various graphite concentrates that are classified by flake size and also valued by their carbon content.
The annual milling capacity is 323,670 tonnes per year to produce 44,300 tonnes of concentrate annually at a cost of $441 per tonne of concentrate. The concentrate will grade 97.8% Graphitic Carbon ("Cg") on average for a 25-year open pit mine life based on current open pit reserves. All graphite concentrate produced with flakes larger than 200 mesh contain more than 98% Cg.
The FS is based on the Pilot Plant test work run by SGS Mineral Services in Lakefield, Ontario, during the spring of 2013 and announced in a news release on August 21st, 2013. The concentrator process flow sheet is based on standard flotation circuits followed by a series of polishing mills that upgrade the carbon content by cleaning impurities present in the ore that are generally found on the graphitic carbon flake surfaces of the Lac Knife mineralization. Pilot Plant recovery was 91%, full scale, consistent operations should improve on the mill process recovery. Flake size distribution is expected to increase in favour of larger flake as the full scale plant will start with a SAG mill which is better suited to mitigate flake damage as opposed to crushing and grinding methods used in the pilot plant.
Lac Knife is unique in that all natural flake graphitic concentrates produced with flake size above 200 mesh (75 microns) size are more than 98% Cg. This allows Focus to divert finer sized products that would typically be difficult to sell due their flake size to higher value added products such as spherical graphite for batteries due to the high carbon content of 98% carbon (See "Lithium Battery Coin Cell Test Results" below).
Proven and Probable Mineral Reserves:
The open pit design includes 429 kt of Proven Reserves and 7,428 kt of Probable Reserves for a total of 7,857 kt of Proven and Probable Mineral Reserves grading 15.13% Cg. The Mineral Reserves which account for mining dilution and ore loss are reported at a cut-off grade of 3.1% Cg. In order to access these reserves, 2,746 kt of overburden, 10,926 kt of waste rock and 231 kt of Inferred Mineral Resources must be mined. This total waste quantity of 13,903 kt results in a stripping ratio of 1.8 to 1. Table 2 presents the Lac Knife open pit mineral reserves that were estimated for the FS. The remaining Measured and Indicated Resources within the Lac Knife deposit will help to develop the mid and long-term growth profile for the company (See Table 5 for MRE).
Table 2
Lac Knife Open Pit Mineral Reserves
Category Tonnage (kt) Cg Grade (%)
Proven 429 23.61
Probable 7,428 14.64
Proven and Probable 7,857 15.13
A pit optimization analysis was carried out using the MS-Economic Planner module of MineSight® which ran the Lerchs-Grossmann algorithm to determine the economic limits of the deposit. The analysis showed that the open pit design for the Feasibility Study should be based on a 25-year mine life that includes approximately 82% of the Measured and Indicated Mineral Resources.
The open pit design incorporates 10 m high benches and follows the pit slope recommendations from the 2014 geotechnical investigation. The pit is 700 m long and 400 m wide at surface and has a maximum pit depth of 100 m.
Mining will be carried out by a mining contractor who will use conventional open pit mining methods that include drilling and blasting followed by a hydraulic excavator loading a fleet of 46-tonne haul trucks. The mine will be operated seasonally (7 months of the year) and a front-end wheel loader will be used to feed the processing plant from an ore stockpile during the winter months.
The study was conducted with engineering and estimation methods appropriate to target an estimate accuracy of 15% that is standard and realistic for capital and operating cost estimates in a Feasibility Study. Based on an extensive risk review exercise the contingency is 11.5%. The Capital Expenditures in Table 3 outline what is needed to construct the mine, processing plant, power line and all associated infrastructure that is estimated at a total of $165.55 million.
Table 3
Lac Knife Capital Expenditure - Cost Centers CDN$ millions
Mine equipment, infrastructure, and pre-stripping 4.21
Infrastructure 11.62
Primary Crushing 7.02
Concentrator 62.24
Environmental and Tailings Management 8.22
Additional Infrastructure 15.4
Indirect Costs 39.77
Contingency (11.5%) 17.07
Sub Total 165.55
The company is currently in discussion with vendors to define financing packages for equipment. This will result in a reduced up front capital and add to the basket of financing options currently being investigated. Another financing option currently under due diligence is Supply Chain Financing ("SCF") based on an offtake agreement signed in December 2013 for a minimum of 50% of Lac Knife's production. SCF is a non-dilutive alternative to equity financing and is not as encumbering as traditional debt, or royalty financing. Future off-take agreements will contain a financial component as well.
This project-financing alternative could include equity and low interest debt as well as a signing bonus to execute an offtake agreement. These options have the potential to enhance future project economic metrics, and the company continues to discuss with several interested parties on various options.
Table 4
Lac Knife Operating Expenditures (25 year average) Cost Centers $/Tonne of Concentrate
Mining 126.95
Processing Costs (Concentrator) 239.37
General Administration Mine Site 74.70
Total Operating Costs 441.02
The operating costs per tonne of concentrate produced are $441 (See Table 4 below). This is an improvement over the updated Preliminary Economic Assessment (PEA) that showed $458 per tonne of concentrate produced. One key variable to low production costs is Lac Knife's project location giving relatively easy access to low cost hydroelectric power from Hydro Quebec at the intersection of the access road and Provincial Highway 389.
Permitting is well underway with the ESIA to be submitted by the end of the summer and the Mine Closure Plan is planned for submission mid-summer. Focus continues to communicate, meet, and listen to local communities and will be increasing these efforts now that the feasibility is completed and the impacts are known.
The National Instrument 43-101 ("NI 43-101") MRE was performed by Pierre Desautels of AGP Inc. and was announced January 28th. It increased the Measured and Indicated Resources by 92% for the Lac Knife Deposit. The MRE is based on both the 2012 and 2013 additional exploration and definition drilling programs for a total of 92 holes, and 9,103 meters that successfully achieved the designed goal to upgrade the quality of existing Indicated and Inferred Resources to the Measured and Indicated Resource categories. This is in addition to 105 previous drill holes that totaled 9,217 meters.
Measured and Indicated Resources are estimated at 9.6 million tonnes grading 14.77% at a 3% Cg cut-off grade. Additionally there are 3.1 million tonnes of Inferred Resources at 13.25 % Cg using a 3% cut-off in this updated resource estimate presented in Table 5.
Table 5
Lac Knife Mineral Resource Estimate Categories Tonnage (t) Cg (%) In situ Graphite(t)
Measured 432,000 23.66 102,000
Indicated 9,144,000 14.35 1,312,000
Measured + Indicated 9,576,000 14.77 1,414,000
Inferred 3,102,000 13.25 411,000
Mineral Resources are not Mineral Reserves and do not have demonstrated economic viability. (See Table 2 above for Reserves).
Lithium Battery Coin Cell Test Results
On May 27th, Focus Graphite announced it "Succeeded in Producing Extremely High-Performing Coated Spherical Graphite for Lithium Ion Batteries". The results from coin cell performance testing performed on Lac Knife Spherical Graphite ("SPG") produced outstanding performance metric results. The benchmark products have a typical irreversible capacity loss ("ICL") of 6-10% ICL. Lac Knife SPG showed two ICL test results measuring 1.01% and 1.44%, truly remarkable results. Essentially these battery performance tests illustrated that the Irreversible Capacity Loss ("ICL") was reduced by 75% compared to the benchmark products available in the market today.
These tests confirm Focus' capability to tailor lithium ion battery anode grade SPG and value added products to meet the most stringent customer specifications
Lac Knife anode SPG is unique in having such a low ICL performance metric, this could be attributed to the unique properties of the Lac Knife high carbon content concentrate that grades 98% C, even in the finer flake size concentrate products down to 200 mesh (75 microns) that are usually the most difficult products to sell. This holds the potential to allow Focus market access to significantly higher margin value added products with a finer grade lower cost product creating a unique opportunity.
"Commercially and competitively, these results open the door for Focus to confidently accelerate our plans to market and sell our battery grade, high margin products to potential partners and customers," said Mr. Baxter.
Qualified Persons
The technical information within this news release was approved by Project Leader Mary- Jean Buchanan Eng., and Jeffrey Cassoff Eng., Lead Mining Engineer, and Ewald Pengel P. Eng., Senior Metallurgist, who was responsible for concentrator design, all from Met-Chem Canada Inc., and all individuals that are Qualified Persons under NI 43-101 guidelines and all independent of the issuer. Pierre Desautels P.Geo. of AGP Inc. completed the NI 43-101 Mineral Resource Estimate report and is also independent of the issuer.
The technical information in this news release was prepared by Mr. Don Baxter, P. Eng., Focus President & Chief Operating Officer, a Qualified Person as defined by NI 43-101 guidelines, who has reviewed and approved the technical content of this news release.
About Focus Graphite
Focus Graphite Inc. is an emerging mining development company with an objective to produce value added products initially for the lithium ion battery market from the Lac Knife graphite deposit located south west of Fermont, Québec. The Lac Knife project hosts a NI 43-101 compliant Measured and Indicated Mineral Resource Estimate* of 9.6 million tonnes grading 14.77% graphitic carbon (Cg) as natural flake graphite with an additional Inferred Mineral Resource Estimate* of 3.1 million tonnes grading 13.25% Cg. Focus' goal is to assume an industry leadership position by becoming a low-cost producer of technology-grade graphite. The feasibility study results released on June 25th, 2014 for the Lac Knife Project indicated that the project is economically viable and has the potential to become a low cost graphite producer based on 7.86 million tonnes of Proven and Probable Reserves grading 15.13 Cg. On May 27, 2014 the Company announced the Potential for High Value Added Sales in the Li-Ion Battery Sector following battery coin cell tests performed on Lac Knife Spherical Graphite ("SPG"). Testing measured the performance metrics and confirmed Focus' capability to tailor lithium ion battery anode grade graphite and value added products to meet the most stringent customer specifications. This is a result of being a technology-oriented enterprise having a vision of building long-term, sustainable shareholder value. Focus also invests in the development of graphene applications and patents through Grafoid Inc.
* Mineral resources are not mineral reserves and do not have demonstrated economic viability
About Met-Chem Canada, Inc.
Met-Chem is an internationally renowned consulting engineering firm established in 1969 to provide all phases of geology, mining, mineral processing and engineering services throughout the world. From its headquarters in Montreal, Met-Chem offers the mining industry professional expertise that covers scoping, pre-feasibility and feasibility studies, basic and detailed engineering, procurement and construction management, training, start-up, commissioning and operations assistance.
About Industrial Minerals-DATA
Industrial Minerals ("IM") Data-Graphite is a dedicated pricing and analysis service for the natural graphite market. Tracking over 40 different grades from around the world, IM Data's pricing database supplies up-to-date information which allows for tracking both current and historical trends as far back as 1988. Their analysts, based in London and Shanghai, collect information directly from the industry, providing exclusive insight and market intelligence. With up-to-date pricing data, market analysis and commentary, IM Data Graphite is the only independent source of accurate, detailed and independent information for the natural graphite market.
Altima Resources (TSX:ARH) (:ARSLF) Testing Chambers 5-35-41-11 W5M Well and Completing Pipeline and Production Facility
CALGARY, ALBERTA--(Marketwired - Jun 24, 2014) - Altima Resources Ltd. (TSX VENTURE:ARH)(FRANKFURT:AKC)(PINKSHEETS:ARSLF) announces that the Altima Chambers 5-35-41-11 W5M well (5-35 well) completed fracture stimulation operations on June 19, 2014. Three separate fracture stimulations treatments were conducted on five formations, and all flowed back gas and liquids. Operations are continuing to mill out plugs and commingle all zones, run production tubing, and perform a flow and build up test on the well.
Altima has completed the 1.37 kilometer, 4 inch natural gas pipeline from the 5-35 well to a newly constructed riser located at 9-35-41-11 W5M. This infrastructure will connect the 5-35 well into Altima's existing Chambers North production and gathering system. Well site facilities will be installed after the flow test is completed, and the Company anticipates production from the 5-35 well to commence in early July.
As reported in the Company's March 3 and March 17, 2014 News Releases, the 5-35 well is the second well drilled under Altima's Participation Agreement with Whistler Oil and Gas Pty. Ltd., and was drilled to a Total Depth of 3,158 meters and Rig Released on March 16, 2014. Under the subject Whistler Agreement, an additional follow up well has been licensed and new well location constructed at 9-35-41-11 W5M.
The Company's mostly contiguous land base at Chambers-Ferrier totals twenty-seven (27) sections (17,280 gross acres) with an approximate average working interest of 86% in 16 of the 27 sections and varying interests in eleven (11) wells.
Richard Switzer, CEO, President and a Certified Professional Geologist, is the Qualified Person under National Instrument 51-101 responsible for preparing and reviewing the data contained in this press release.
ON BEHALF OF THE BOARD
Richard Switzer, CEO and President
Theralase (TSXV: TLT) (TLTFF: OTC) Partners with University of Toledo in Cancer Research
(via Thenewswire.ca)
Toronto, Ontario / TNW-ACCESSWIRE / June 18, 2014 -- Theralase Technologies Inc. ("Theralase") (TSXV: TLT) (TLTFF: OTC Pink(R)) announced today that it has executed an agreement with the University of Toledo to conduct preclinical research into the safety and effectiveness of Theralase's Photo Dynamic Compounds (PDCs) in the destruction of bladder cancer in a rat model. The study is entitled, "The use of novel Photo Dynamic Therapy (PDT) in a rat bladder tumor model."
The first phase of this preclinical study will be to optimize the effectiveness of various Theralase PDCs in the destruction of rat bladder tumor cells (AY-27) using various PDC concentrations and laser light doses.
The second phase will be to complete two in vivo rat tumor model studies. The first set of experiments will examine PDC uptake and distribution in rat bladder tumors. The second set of experiments will focus on destroying rat bladder cancer safely and effectively through the instillation of PDCs into rat bladders exhibiting cancerous tumours and then light activating them.
The outcome of these experiments will provide independent confirmation and optimization of the lead PDC selected for bladder cancer destruction and prove the safety and efficacy of the Theralase lead PDC in the destruction of bladder cancer in a live animal model.
Dr. Arkady Mandel, Chief Scientific Officer at Theralase Inc. stated, "I am interested in reviewing the results of an independent confirmation and optimization of the safety and efficacy of the Theralase PDC in destroying bladder cancer in an orthotopic (occurring at the normal place) rat model. The University of Toledo is a great choice for this research, as their group is well known for expertise in the urological applications of PDT. The results of this preclinical research will allow the Company to progress to Good Manufacturing Practice (GMP) manufacture of the lead PDC. We are delighted to have the experience and knowledge of the University of Toledo on board to execute this pivotal preclinical research, as they will be instrumental in helping us prove the destruction of rat bladder cancer with PDCs in 2014, preparing us for clinical application in 2015."
Roger Dumoulin-White, President and CEO of Theralase stated that, "Theralase is delighted that we have executed a research agreement with the University of Toledo. Completion of this work is pivotal for Theralase to independently validate and optimize our research findings in the PDT destruction of bladder cancer. Results of the University of Toledo's work will determine the uptake and distribution of the PDCs into bladder cancer tumors versus healthy bladder and the amount of PDCs required to safely and effectively destroy bladder cancer in a live animal model. This data will be instrumental in helping to determine the proper amount of PDC required for human application. I look forward to reporting on the results of this exciting research later this year."
About Theralase Technologies Inc.
Theralase Technologies Inc. ("Theralase") (TSXV: TLT) (TLTFF: OTC Pink(R)) designs, manufactures and markets patented, superpulsed laser technology used in eliminating pain and destroying cancer. Theralase technology is safe and effective in eliminating pain, reducing inflammation and accelerating tissue regeneration in numerous nerve, muscle and joint conditions. Theralase is developing patented Photo Dynamic Compound (PDC) technology that is able to target and destroy cancers, bacteria and viruses when light activated.
Theralase's (TLTFF) (TLT.V), Cancer Technology Demonstrates Vaccine-Like Properties
Whitefish, MT / June 16, 2014 / Conventional cancer treatment involves surgically removing cancerous tumors and then killing the remaining cells with toxic chemotherapy drugs. Unfortunately, these approaches involve invasive surgeries and the indiscriminant killing of cells that lead to the immune system being compromised. The success rates for these treatments, particularly in later stage cancers, also leave a lot to be desired.
Companies like Galena Biopharma (GALE), Inovio Pharmaceuticals (NYSE MKT: INO), and ImmunoCellular Therapeutics (IMUC) have tried to empower the patient's own immune system to selectively target cancer cells rather than killing indiscriminately. The idea is to create a kind of cancer vaccine that separates proteins from cancer cells and immunizes patients against those proteins to stimulate an immune reaction.
In this article, we'll take a look at a different non-invasive approach that's achieves similar vaccine-like properties using the power of light.
Killing Cancer with Light
Theralase Technologies Inc. (TLTFF) (TLT.V), a designer, manufacturer, and marketer of patented super-pulsed laser technologies used in eliminating pain and destroying cancer, has taken a different variation of that approach by introducing Photo Dynamic Compounds ("PDCs") into cancerous cells and then killing those cells by exposing them to cold laser light.
In preclinical animal testing at Princess Margaret Cancer Centre, University Health Network ("UHN"), the company injected mice with 350,000 colon cancer cells to produce tumors that grew to 5mm in size. They were subsequently treated with an intra-tumoral injection of the firm's lead PDC and exposed to Near InfraRed ("NIR") light to activate the PDCs and destroy the vast majority of tumors.
Vaccine-like Properties
The same mice that received the initial PDCs were re-injected with the same number of colon cancer cells 13 to 23 days later. Interestingly, with no further treatment intervention, 40% of the mice demonstrated either a small tumor regrowth that quickly regressed or in 60% of the mice, no tumor regrowth at all. The results suggest a short-term immune-mediated ("memory response") tumor rejection with vaccine-like properties.
Approximately 10 months after that injection, the same mice were injected for a third time with 350,000 additional colon cancer cells. 100% of the mice showed no signs of tumor regrowth, even at a 3-month follow-up, suggesting the presence of a long-term anti-tumor ("memory response") immunity responsible for complete tumor rejection. Mice in control experiments did not survive longer than a month following the cancer cell injection.
Potential Implications
The potential for short-term and long-term anti-cancer memory response – or vaccine-like properties, would represent a major breakthrough in cancer research and provide substantial treatment benefit and survival advantage to cancer patients. In addition to the immunity, the patented therapy's potential to rapidly kill patient-specific cancer cells and regress tumors provides the immediate efficacy needed.
"This is one of the first preclinical trials to show that it's possible to generate long-term anticancer memory response," said Theralase CSO Dr. Arkady Mandel. "For the first time in our research program, we have demonstrated that NIR Photo Dynamic Therapy (PDT) leads not only to long standing clearance of colon cancer cells, but also provides long lasting protection against further tumor cell challenge in young and older mice."
Looking Ahead
Theralase Technologies plans on continuing its pre-clinical studies to confirm the findings for a range of induced and spontaneous animal tumor models. Once the results have been adequately tested on animals, researchers hope to replicate the characteristics in humans and demonstrate the same efficacy. Successful results in humans could have immense implications on the war on cancer.
With a market capitalization of just $17.6 million, investors have the opportunity to buy into a promising cancer-fighting technology, as well as an existing pain management franchise that already generates revenue. Clinical trials on humans are slated for early 2015 and the potential for strategic partnerships and additional clinical results along the way could catalyze the stock higher.
Theralase (TSXV: TLT) (TLTFF) Stock Upgraded on US OTC Market
Toronto, Ontario / TNW-ACCESSWIRE / June 12, 2014 / Theralase Technologies Inc. ("Theralase") (TSXV: TLT) (TLTFF: OTC Link(R)) announced that effective June 3, 2014, its common shares, which trade in the United States Over The Counter (OTC) market under the trading symbol TLTFF, have been upgraded on a venue change from the Grey Market to the OTC Link Market.
OTC Markets facilitates electronic trading with its SEC registered Alternative Trading System known as OTC Link(R) ATS. This system is owned by OTC Link(R), a subsidiary company of OTC Markets Group, that is a fully registered broker-dealer and member of FINRA. The OTCQX(R), OTCQB(R) and OTC Pink(R) platforms traded $135 billion of transactions in 2012 with an average daily dollar volume of $600 million, comprising 10,000 corporate securities; which includes 650 U.S. banks, 2,300 companies that report to the Securities and Exchange Commission (SEC), 1,600 companies that pay dividends, 1,400 American Depository Receipts (ADRs) and 1,400 foreign companies. Together these corporations boast an aggregate market capitalization of approximately $11.6 trillion.
Roger Dumoulin-White, President and CEO of Theralase stated that, "As Theralase continues to execute on its strategic initiatives and accelerate our growth in both our therapeutic and anti-cancer divisions, there is a growing interest south of the border to invest in our common stock. By changing venues from Grey Market to OTC Link(R), the Company is able to provide further transparency and financial reporting to our US based investors allowing them access to more information and hence a greater comfort in investing in Theralase. As Theralase delivers on its corporate milestones in both divisions in 2014 and 2015, it would be reasonable to expect the interest in acquiring Theralase common stock to increase among US based investors, leading Theralase to pursue full financial reporting and disclosure to the SEC to allow an eventual listing on a major US exchange, such as NASDAQ."
About Theralase Technologies Inc.
Theralase Technologies Inc. ("Theralase") (TSXV: TLT) (TLTFF: OTC Link(R)) designs, manufactures and markets patented, superpulsed laser technology used in eliminating pain and destroying cancer. Theralase technology is safe and effective in eliminating pain, reducing inflammation and accelerating tissue regeneration in numerous nerve, muscle and joint conditions. Theralase is developing patented Photo Dynamic Compound (PDC) technology that is able to target and destroy cancers, bacteria and viruses when light activated.
Theralase (TSXV: TLT) (TLTFF: OTCBB) CEO Interviewed by CBC TV about Progress in Anti-Cancer and Pain Research
Roger Dumoulin-White talks to Amanda Lang about Theralase's strategy to deliver value to shareholders and patients
Toronto, Ontario / TNW-ACCESSWIRE / June 5, 2014 / Theralase Technologies Inc. ("Theralase") (TSXV: TLT) (TLTFF: OTCBB) announced today that CBC's senior business correspondent and anchor on The Lang and O'Leary Exchange, Amanda Lang, interviewed Theralase President and CEO, Roger Dumoulin-White about the Company and how the Company is breaking significant new ground in anti-cancer and pain management technology.
Link to the show: http://www.cbc.ca/revenuegroup/the-lang-oleary-exchange.html
Roger Dumoulin-White, President and CEO of Theralase, stated, "My appearance on Canada's top business program confirms that Theralase is emerging as a major research and manufacturing company in two of the most important sectors of the healthcare industry - seeking a cure for cancer and alleviating pain. It is estimated that $91 Billion is spent on the war on cancer and $100 Billion on pain in the United States, annually.
For the last 20 years, Theralase has designed and manufactured patented therapeutic laser technology, which is used for the elimination of pain, reduction of inflammation and dramatic acceleration of tissue healing. Theralase has sold over 800 systems in Canada and over 400 systems in the US and international markets to licenced healthcare practitioners such as: medical doctors, chiropractors, physical therapists and athletic therapists.
Theralase has been so successful in healing nerve, muscle and joint conditions in clinical practice that Theralase's scientists decided to investigate a new application for lasers, the destruction of cancer. Theralase's anti-cancer technology focuses on using specially designed molecules called Photo Dynamic Compounds or PDCs that are able to localize to the DNA of cancer cells and then, when activated by light, destroy the cancer cells.
Theralase recently completed research that demonstrated that its PDC technology is not only able to destroy the primary tumour, but also discovered a "memory response" for the technology. In these animal studies, once the primary tumour was destroyed, repeated injections of cancer cells at a few weeks post-treatment, or even 10 months post-treatment, did not generate cancerous tumours and in fact prevented the recurrence of cancer.
Roger Dumoulin-White, President and CEO of Theralase, stated, "Amanda Lang is extremely knowledgeable and understood the application and benefits of Theralase's therapeutic laser and anti-cancer technology for both the elimination of pain and the destruction of cancer, respectively. Our therapeutic laser technology has been clinically proven to eliminate pain, reduce inflammation and accelerate tissue repair, healing millions of patient's nerve, muscle and joint conditions, effectively. We are very excited about the possibilities for Theralase's anti-cancer technology. If it shows the same efficacy in humans that it has in animals, then our PDC anti-cancer technology and the implications of this "memory response" discovery are nothing short of game changing for both Theralase and for cancer patients."
About The Lang and O'Leary Exchange:
The Lang and O'Leary Exchange is a Canadian business news television series, which airs weekdays on CBC Television and CBC News Network. Hosted by CBC's senior business correspondent Amanda Lang and entrepreneur/investor Kevin O'Leary, the series presents a summary of the day's major business stories in a manner similar to Lang and O'Leary's earlier Business News Network series SqueezePlay.
About Theralase Technologies Inc.
Founded in 1994, Theralase Technologies Inc. ("Theralase") (TSXV: TLT) (TLTFF: OTCBB) designs, manufactures and markets patented superpulsed laser technology used in eliminating pain and destroying cancer. Theralase technology is safe and effective in eliminating pain, reducing inflammation and accelerating tissue regeneration of numerous nerve, muscle and joint conditions. Theralase is actively developing patented technology that is able to target and destroy cancers, bacteria and viruses when activated by light.
Additional information is available at www.theralase.com and www.sedar.com .
Theralase Laser Technology (TSXV:TLT) (OTC:TLTFF), Used By Star Athletes for Pain Management
Whitefish, MT / June 2, 2014 / Theralase Technologies Inc. (TSXV:TLT) (OTC:TLTFF), a key player in the life sciences industry is breaking ground with its laser pain treatments for celebrity athletes. Baseball legend Roy Halladay and tennis star James Blake are just two of many celebrity sports athletes that have extensively used and vouch for Theralase’s TLC-1000 Cold Laser System, a system developed and optimized over the last 20 years.
Extensive clinical research proves that the TLC-1000 is able to reduce pain and accelerate tissue healing, dramatically improving the lives of both professional athletes and the everyday person experiencing muscle pain, joint pain or fatigue. The Theralase super pulsed laser system can penetrate up to 4? into tissue, to promote cellular regeneration at the source of the injury and is the only laser on the market known to activate all three cellular pathways.
Theralase has over 800 systems installed and in use in Canada, with an additional 400 more systems in the US and internationally. To date, over 1 million patients have been successfully treated, and that number is growing daily.
“I had to withdraw from the Rogers Masters in Montreal due to a severe abdominal muscle strain,” said James Blake, #14 ranked professional tennis player in 2007. “For the next two weeks, I had two laser treatments per day with the Theralase(r) 1000 cluster laser, which accelerated the tissue healing and reduced the pain... Theralase(r) laser treatments were very helpful in accelerating my recovery time.”
In addition to healing injuries, many athletes use the technology to maintain musculoskeletal health. Roy Halladay, Cy Young Award Winner and former Major League Baseball all-star, used the technology in this way during his professional baseball career, saying, “I use the Theralase(r) laser to keep my throwing arm healthy. It reduces fatigue and allows me to play at my peak, game after game
Theralase (TSXV: TLT) (OTCBB: TLTFF) Releases 1Q2014 Financial Results
May 30, 2014 -- Theralase Technologies Inc. ("Theralase") (TSXV: TLT) (OTCBB: TLTFF) released its first quarter 2014 financial results today, demonstrating a slight increase in revenue for the three month period ended March 31, 2014, edging up 5% year over year, while successfully advancing its patented next generation therapeutic laser and cancer destruction technologies.
Total revenue for the three-month period ended March 31, 2014 increased 5% from $342,900 to $361,179 year over year.
The net loss for the three-month period ended March 31, 2014 was $344,074 (including $15,897 of net non-cash expenses) compared to a net loss of $332,435 in the same period in 2013 (including $56,829 of net non-cash expenses), a 3.5% increase.
The net loss reflects the ongoing commitment of Theralase to invest in the next generation of therapeutic laser and cancer destruction technologies, from existing therapeutic laser sales.
Selling and marketing expenses increased 12% from $109,391 to $122,278 for the same period in 2013, due primarily to increased spending on product marketing and travel costs.
Administrative expenses decreased 4% from $249,767 to $240,373 for the same period in 2013, due to reductions in administrative personnel and stock based compensation.
Research and development costs decreased 1% from $199,597 to $197,792 for the same period in 2013. The slight decrease reflects the approaching completion of the development of the patented TLC-2000 therapeutic laser technology and the ramp-up in the research and development costs associated with the cancer destruction technology.
Roger Dumoulin-White, President and CEO of Theralase stated that, "The Company is on-track to launch the next generation therapeutic laser technology in 4Q2014 in Canada. The patented TLC-2000 biofeedback therapeutic laser technology has been researched and designed to revolutionize the therapeutic laser industry, by providing patient specific treatments that adapt to a patient's physical characteristics delivering best-in-class performance in the elimination of pain, reduction in inflammation and dramatic acceleration of tissue healing. The medical community and especially the patients who suffer from pain and inflammation on a daily basis have been waiting for a technology of this efficacy and performance to enter the market for a long time."
Mr. Dumoulin-White went on to say, "Our patented cancer technology is demonstrating significant success in preclinical research and is on track for clinical evaluation in humans for bladder cancer as early as 1Q2015. If our PDC technology, with its recent advances in providing an immune-mediated "memory response" in the destruction of cancer is proven effective in cancer patients, the implications of this discovery are nothing short of game changing for both Theralase and for the cancer patients, who are inflicted with this deadly disease. The ability to destroy the original cancer and at the same time program the body's immune system to prevent its recurrence, after only a single treatment, is nothing short of miraculous. The scientific, clinical and engineering teams at UHN, Acadia and Theralase are all fully dedicated to bringing the Theralase anti-cancer PDC technology to the forefront of clinical treatment, as soon as possible, in order to help eradicate the world of cancer and assist cancer patients."
In order to help facilitate the launch of these two ground breaking technologies in 2014 and 2015, the Company closed a $3.15 M private placement on November 7, 2013, issuing 21,000,000 Units to investors at a price of $0.15 per Unit. Each Unit consisted of one common share in the capital of the Company and one non-transferable common share purchase warrant. Each whole Warrant will entitle the purchaser to purchase one additional common share in the capital of the Company until November 7, 2015 at a price of $0.20.
About Theralase Technologies Inc.
Theralase Technologies Inc. designs, manufactures and markets patented, superpulsed laser technology used in healing injured tissue and destroying cancer. Theralase technology is safe and effective in eliminating pain, reducing inflammation and dramatically accelerating tissue regeneration of numerous nerve, muscle and joint injuries. Theralase is actively developing patented technology that is able to target and destroy cancers, bacteria and viruses when light activated.
The complete interim consolidated financial statements and MD&A for the three month period ended March 31, 2014 may be viewed at www.theralase.com and www.sedar.com .
Theralase (TLT.V) (TLTFF:OTCBB) Discovers Anti-Cancer Memory Response
Toronto, Ontario / ACCESSWIRE / May 29, 2014 / Theralase Technologies Inc. ("Theralase") (TLT.V) (TLTFF:OTCBB) announced today that in preclinical animal testing, performed at Princess Margaret Cancer Centre, University Health Network ("UHN"), it has discovered that its lead Photo Dynamic Compound (PDC), intended for the destruction of cancer, has demonstrated an ability to render animals immune to repeated exposures of the same cancer.
This initial data has been accepted for presentation at the 37th Annual American Society for Photobiology taking place in San Diego, California in June 2014.
In previous research conducted at UHN by Theralase, mice were injected with 350,000 colon cancer cells (murine cell line CT26.CL25) to produce tumours that were allowed to grow to approximately five millimeters in size. They were treated with an intra-tumoural injection of Theralase's lead PDC (3 mg/kg TLDOsH2IP) and then illuminated by Near Infrared (NIR) light (808 nm, 600 J cm-2) to activate the PDC. The vast majority of tumours were completely destroyed, with the PDC treatment demonstrating prolonged tumour regression.
In this latest research, the same mice who received the initial, successful Photo Dynamic Therapy (PDT) were re-injected with the same number of colon cancer cells, 13 to 23 days later. With no further treatment intervention, mice in these experiments, demonstrated either a small tumour regrowth, which quickly regressed, or in the majority of animals, no tumour regrowth at all, suggesting a short-term immune-mediated (immune "memory response") tumour rejection.
To further prove the resilience of the PDT treatment, these same animals were then injected a third time with an additional 350,000 colon cancer cells at ten months post PDT treatment. None of these animals showed any sign of tumour regrowth, even at 3 months post follow up, suggesting the presence of a long-term anti-tumour immunity, responsible for complete tumour rejection.
To strengthen the data, control experiments were conducted where age matched mice without prior tumour exposure or PDT treatment were injected with the same number of colon cancer cells, where the majority of these mice proceeded to develop tumours and did not survive more than 1 month following the injection.
These initial results are now being further researched by Theralase and UHN scientists to confirm the immune-mediated (immune "memory response") tumour rejection in additional subject animals. This potential short term and long term anti-cancer memory response suggests a major breakthrough in cancer research and may provide substantial treatment benefit and survival advantage to cancer patients. Technology that is able to rapidly and effectively destroy "patient-specific" cancer cells, prevent their recurrence and provide long lasting protection against local and distant metastasis, offers immense clinical benefit to cancer patients and the facilities that treat their disease.
Dr. Arkady Mandel, Chief Scientific Officer of Theralase stated, "This is one of the first preclinical trials to show that it's possible to generate a long-term anticancer memory response. For the first time in our research program, we have demonstrated that NIR PDT leads not only to long standing clearance of colon cancer cells, but also provides long lasting protection against further tumour cell challenge in young (eight to ten weeks old) and older (ten to eleven month old) mice. It is our first step toward the long-term goal of developing an affordable and practical vaccine to prevent cancer recurrence. The next steps are to further validate this research with additional animals and then find the best way of translating this research into a human clinical trial. To complete our preclinical and clinical development in this ground breaking work, we are collaborating with experts in medical biophysics, immunology and clinical oncology at UHN and with other internationally acclaimed clinical research institutes to further advance this remarkable platform technology."
Dr. Lothar Lilge PhD, Professor in the Department of Medical Biophysics at the University of Toronto, Senior Scientist, Princess Margaret Cancer Centre, University Health Network stated that, "We are delighted that we were able to partner in the preclinical research for this ground breaking discovery. The ability to effectively destroy cancer and simultaneously stimulate the immune system to target micro metastasis beyond the initial treatment volume is necessary to provide long term disease control. We will now proceed to confirm these findings for a range of induced and spontaneous animal tumour models."
Dr. Michael Jewett MD, clinician investigator and uro-oncologist at UHN stated, "I am excited about the possibilities of this discovery. If this newly discovered characteristic of the Theralase PDCs can be replicated in humans and demonstrate the same efficacy that it has in small animals, then the implications to the war on cancer could be immense. I look forward to furthering this preclinical work to the clinical stage to validate its efficacy in humans."
Roger Dumoulin-White, President and CEO of Theralase stated that, "If our PDC technology is proven effective in cancer patients, the implications of this discovery are nothing short of game changing for both Theralase and for cancer patients. The ability to destroy the original cancer and also program the body's immune system to prevent its recurrence, after only a single treatment, is nothing short of miraculous. Born a technical person at heart, I have always marvelled at the complexity of the human body and regarded it as the single most complex and intricate machine ever devised. The opportunity to bring technology to market that could help preserve the integrity of the human body and destroy such a deadly disease as cancer, fills me with hope and a great sense of accomplishment. The scientific, clinical and engineering teams at UHN, Acadia and Theralase are all fully dedicated to bringing the Theralase anti-cancer PDC technology to the forefront of clinical success, as soon as possible, in order to help eradicate the world of cancer and assist cancer patients stricken with this deadly disease."
About Theralase Technologies Inc.
Theralase Technologies Inc. designs, manufactures and markets patented, superpulsed laser technology used in eliminating pain and destroying cancer. Theralase technology is safe and effective in eliminating pain, reducing inflammation and accelerating tissue regeneration of numerous nerve, muscle and joint conditions. Theralase is actively developing patented technology that is able to target and destroy cancers, bacteria and viruses when light activated.
Additional information is available at www.theralase.com and www.sedar.com .
Theralase (TSXV: TLT) (TLTFF: OTCBB) Anti-Cancer Technology Validated in Prestigious US Chemistry Publication
Toronto, Ontario / TNW-ACCESSWIRE / May 27, 2014 / Theralase Technologies Inc. ("Theralase') (TSXV: TLT) (TLTFF: OTCBB) announced today that its latest research on Photo Dynamic Compound (PDC) technology, proven effective in the destruction of bacteria and cancer, was peer reviewed and invited to be published in the prestigious US Elsevier publication, Coordination Chemistry Reviews.
The new research presents how Theralase's new class of PDCs incorporates systems that act as dual Type I/II PDCs (able to work in oxygenated and non-oxygenated tissue), opening up the possibility of treating hypoxic (low oxygen) tumours with Photo Dynamic Therapy (PDT). These PDCs are remarkable in-vitro centromere binders (localizing to the nucleus of a cell) and photocleavers (ability to damage nucleus), thus destroying cells when exposed to light. They also exhibit no nucleic damage in the absence of light, supporting their high safety and tolerability. This PDT effect translates effectively to animals and has proven superior to the FDA approved PDC Photofrin(R), in this research. The ability to activate the Theralase PDCs from visible to Near Infra Red (NIR) light marks an unprecedented versatility that can be exploited to match treatment depth to tumour target depth, giving rise to PDCs for multi-wavelength activated PDT.
Photo Dynamic Therapy (PDT) is an elegant method for destroying cancer cells. PDCs accumulate in cells intended for destruction and when light activated destroy the intended cell; hence, PDT is best described as a combination therapy that offers selectivity through local interactions between a PDC, light and oxygen. Briefly, light absorption by the PDC produces a reactive excited state that can participate in electron (Type I) or energy (Type II) transfer to ground state molecular oxygen forming either superoxide radical anions or cytotoxic singlet oxygen, respectively. The production of a cytotoxic (cell killing) burst of Reactive Oxygen Species (ROS), notably singlet oxygen has proven effective in eliminating tumours and/or tumour vasculature. The primary advantage of light-based approaches in treating diseases, such as cancer, is that guided light delivery confines drug activity to malignant sites; thereby, reducing collateral damage to surrounding healthy tissue. Consequently, due to the high photostability of the Theralase PDC, very low drug doses can be used (nanograms) with activation at higher light doses, simultaneously eliminating the side effects caused by conventional systemic chemotherapeutics, such as cisplatin.
Dr. Arkady Mandel, Chief Scientific Officer of Theralase stated, "A number of successful efforts have been made by Theralase's research team to satisfy the clinical requirements and to improve the pharmaceutical and therapeutic properties of the original PDCs. The results of our collaborative research with Dr. Lothar Lilge's scientific team at Princess Margaret Cancer Centre, University Health (UHN) and Dr. Sherri McFarland's chemistry team at Acadia University (Acadia) reveal an unprecedented versatility and efficacy of the Theralase's PDCs. The research data published in the high impact journal Coordination Chemistry Reviews may lead to development of the first-line of patient specific PDT. I am delighted that Theralase has established a very strong partnership with UHN and Acadia to progress this pivotal technology to the next milestone, the completion of an orthotopic animal model for bladder cancer. Together with clinical guidance by Dr. Michael Jewett, a Professor of Surgery (Urology) at the University of Toronto and one of the lead clinician investigators and uro-oncologists at UHN, our research provides excellent preclinical support to Theralase to finalize the regulatory submissions and prepare us for a Phase 1/2a human clinical trial to evaluate the technology in patients inflicted with bladder cancer."
Dr. Lothar Lilge PhD, Professor in the Department of Medical Biophysics at the University of Toronto, Senior Scientist, Princess Margaret Cancer Centre, University Health Network stated that the, "Publication of our research in Coordination Chemistry Reviews validates the importance of the efforts of Acadia University and UHN, with the fully committed support of Theralase, in developing a novel approach for the destruction of solid tumours, preferably in a single administration, thus significantly improving the quality of life of cancer patients. The results obtained to date provide strong support and encouragement to complete the small outstanding preclinical work at UHN to properly position this exciting technology for human clinical studies at the earliest feasible point in time."
Dr. Sherri McFarland PhD, Professor of Chemistry at Acadia University stated that, "I am delighted to work with a strong partner such as Theralase in the development of these PDCs that I originally invented and optimized with the support of my partners. These PDCs have proven to be very potent compounds in the destruction of cancer cells in very small doses and I am excited to lead the development of the PDCs and be part of the team completing the preclinical work in 2014 to support human clinical studies in early 2015."
Roger Dumoulin-White, President and CEO of Theralase stated that, "Coordination Chemistry Reviews is a highly renowned publication known for publishing chemistry research of the highest calibre. It is an honour for this cutting-edge research to be recognized in a publication of this level, further lending credence to the importance of the cancer research we are undertaking with our partners, UHN and Acadia. Targeting cancer cells regardless of tissue depth, enables Theralase to customize its patented technology to be "patient specific" to destroy cancer regardless of where it may reside in the body."
About Theralase Technologies Inc.
Theralase Technologies Inc. designs, manufactures and markets patented, superpulsed laser technology used in eliminating pain and destroying cancer. Theralase technology is safe and effective in eliminating pain, reducing inflammation and accelerating tissue regeneration of numerous nerve, muscle and joint conditions. Theralase is actively developing patented technology that is able to target and destroy cancers, bacteria and viruses, when light activated
Highbank Resources Mobilizes for Summer Aggregate Production
VANCOUVER, B.C., May 21, 2014 (GLOBE NEWSWIRE) -- The Prince Rupert area in Northern British Columbia is about to undergo a construction boom to rival Saudi Arabia's recent infrastructure bonanza.
Multiple massive construction projects include Petronas' commitment to a $36 billion LNG (Liquid Natural Gas) transfer station, and the $11 billion LNG facility in the Port of Prince Rupert area. Total announced construction projects in the region add up to about $60 billion.
Some local suppliers and "picks and shovels" business are going to reap the rewards from the 20 years-plus construction boom.
Highbank Resources (TSX-V:HBK) appears to be one of those companies. Swamp Point North Aggregate Project is just 78 miles north of Prince Rupert and has an at-surface NI 43-101 compliant aggregate resource of 72 million tonnes, with initial off-take commitments at least $22.50 per tonne. Aggregate is an industrial crushed rock that is the primary ingredient in concrete.
Highbank's path to production dominates the company agenda for this summer. HBK has received its Notice of Work (NoW) permit and is currently completing the remaining permit conditions prior to gaining access to the site.
The company expects to receive a timber cutting permit by the middle of May and permit for barging operations shortly after. The environmental baseline study has been completed and will form the basis of an application to expand production in the future. The company is now finalizing the mine operating procedures which are required prior to commencement of operations.
The location of the Swamp Point North Aggregate Project is one of Highbank's competitive advantages. Close to the Prince Rupert construction boom, it is also on tidewater, which creates significant cost advantages when moving bulk materials. Highbank can load the aggregate directly onto barges, whereas many of its competitors are forced to truck in the product.
"We have just completed a $2.7 million financing, which is the first tranche of $4.0 million to bring the property into production," states CEO and President Victor Bryant in an exclusive interview with Financial Press. "Those funds have been used to purchase two 35-ton trucks, a D-8 bulldozer, a 27 foot boat for personnel and supply transportation, a crusher and a washing plant and much ancillary equipment – basically everything we need to develop the site and start mining our at-surface aggregate."
Six individuals were involved in the current financing. Some of them are long term shareholders who believe in Highbank's upside and potential, harnessed to the $60 billion construction boom. Bryant describes them as 'entrepreneurial investors.'
Highbank recently signed a Memorandum of Understanding with Hobiyee-Matrix Logistics, outlining a mutually beneficial agreement between the two companies. This agreement complements a cooperative agreement signed in November 2012 with the Metlakatla.
"Matrix Logistics are a Yellowknife - based company, offering helicopter solutions and exploration logistics," states Bryant, Matrix has a Joint Venture Agreement with Hobiyee Management, a First Nation Corporation established to assist in ensuring that the Nisga'a people are able to participate in business opportunities as they arise. It is possible that Highbank will enter into service agreements with the Nisga'a Village of Gingolx, B.C to provide camp staff-cooks, medics and other personnel.
"It is our intention to employ as many qualified first nation people as possible in equipment operation and camp logistics. We see this not only as smart business, but also as a symbiotic relationship. Highbank has also offered to provide technical and advisory support to the Gingolx in developing other projects."
The Highbank Cooperation Agreement with the Metlakatla First Nation, states that they will participate in the economic benefits of aggregate project at Swamp Point North and through a working relationship in the Prince Rupert area.
In April 2014 Highbank received permission from Fisheries and Oceans Canada, to "Construct a barge loading facility, comprised of barge moorage, barge mooring dolphins and a pile supported aggregate conveyor, and barge landing ramp."
HBK also received verbal confirmation from the Canadian Coast Guard that the Nisga'a has attached no conditions as to the traversing of its traditional marine areas by Highbank's barges.
Aggregate is the world's most mined material next to oil. 2013 global sales revenues are around $100 billion. Annual Canadian consumption of aggregate is 10 to 15 tons per person.
About 75% of Highbank aggregate will be used in concrete. Much of the ground in the in the BC North has a heavy clay composition, which is not stable to build on. Construction companies will excavate the clay and use the more-stable aggregate to back-fill to ensure foundation strength.
It is often a good entry point to invest in companies on the concrete-supply chain just prior to a construction boom.
For context, Saudi Cement (SACCO-AB) manufactures building materials like Portland concrete and oil well cements. Its primary market is Saudi Arabia, which is undergoing an infrastructure boom. SACCO stock price has increased 300% in the last three years.
"We anticipate being in commercial production by the end of August, 2014, achieving our annual production rate of 235,000 tonnes by November," states Bryant, "starting with the 150,000 tonne order from North Coast Concrete. But of course our big opportunity is the $60 billion LNG market which will explode in 2015."
Highbank is currently trading at $0.14 with a market cap of $11.3 million
IntelGenx (TSX-V:IGX) (OTCQX:IGXT) and RedHill Biopharma Report Positive Bioavailability Study Results in Support of Planned European Marketing Application in Q3/2014 for Anti-Migraine VersaFilm(TM) Product
SAINT LAURENT, Quebec, May 21, 2014 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) ("IntelGenx"), a Canadian drug delivery company focused on oral drug delivery, today reported, together with RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) ("RedHill"), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage proprietary drugs, positive results from a comparative bioavailability study with their anti-migraine VersaFilm™ product, an oral thin film formulation of rizatriptan for acute migraines. The study compared the anti-migraine VersaFilm™ product to the European reference drug Maxalt® lingua, marketed in Germany by MSD SHARP & DOHME GMBH, to support the planned submission of a European Marketing Authorization Application ("MAA") for the anti-migraine VersaFilm™ product during the third quarter of 2014.
The results of the study are subject to final quality assurance and an independent study report by the Canadian clinical research organization ("CRO") that conducted the study. The final independent report from the CRO is expected in the coming weeks.
The single-dose, crossover, comparative bioavailability study conducted in Canada followed a positive scientific advice meeting with the German Federal Institute for Drugs and Medical Devices (BfArM) previously announced by RedHill in November 2013. The study, which included 26 healthy volunteers, established the bioequivalence of the anti-migraine VersaFilm™ product and the European reference drug, Maxalt® lingua.
In light of the positive results from the bioavailability study and data from prior clinical studies conducted with the anti-migraine VersaFilm™ product, and subject to various regulatory requirements, IntelGenx and RedHill plan to submit a European MAA during the third quarter of 2014.
IntelGenx and RedHill previously conducted a successful bioavailability study which demonstrated the required U.S. Food and Drug Administration ("FDA") criteria for therapeutic bioequivalence between the anti-migraine VersaFilm™ soluble oral thin film product and the U.S. reference drug, Maxalt-MLT®. Following the successful bioequivalence study, IntelGenx and RedHill announced in 2013 the submission to the FDA and acceptance for review of a New Drug Application ("NDA") seeking marketing approval of the anti-migraine VersaFilm™ product. Following a Complete Response Letter received from the FDA in February 2014, which raised questions primarily related to Chemistry, Manufacturing and Controls ("CMC"), IntelGenx and RedHill recently reported that they believe that FDA approval of the anti-migraine VersaFilm™ product NDA is subject to the satisfactory resolution of the remaining CMC questions, as well as securing a compliant source of the raw material. Accordingly, the companies continue to work with the FDA in order to address and resolve all remaining CMC questions and to secure a compliant source of the raw material.
About the VersaFilm™ Oral Film Product:
The product is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.'s Maxalt®. Rizatriptan is considered one of the most effective oral triptans, a class of molecules that constrict blood vessels in the brain to relieve swelling and other migraine symptoms. The worldwide annual sales of triptans were estimated to have exceeded $1 billion in 20131.
The product is based on IntelGenx' proprietary "VersaFilm™" technology. It dissolves rapidly in the mouth, leading to the absorption of the drug through the gastro intestinal track and into the bloodstream. The administration method of the oral thin film does not require the patient to swallow a pill or consume water, and presents a potentially attractive therapeutic alternative for many migraine patients, including those who suffer from migraine-related nausea, estimated at approximately 80% of the total migraine patient population2.
About IntelGenx:
IntelGenx is a drug delivery company focused on the development of oral controlled-release products as well as novel rapidly disintegrating delivery systems. IntelGenx uses its unique multiple layer delivery system to provide zero-order release of active drugs in the gastrointestinal tract. IntelGenx has also developed novel delivery technologies for the rapid delivery of pharmaceutically active substances in the oral cavity based on its experience with rapidly disintegrating films. IntelGenx' development pipeline includes products for the treatment of indications such as severe depression, hypertension, erectile dysfunction, migraine, insomnia, CNS indications, idiopathic pulmonary fibrosis, oncology and pain, as well as animal health products. More information is available about the company at www.intelgenx.com.
About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) is an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, proprietary formulations and combinations of existing drugs for the treatment of inflammatory and gastrointestinal diseases, including cancer and related conditions. RedHill's current pipeline of proprietary products includes: (i) RHB-104 - an oral combination therapy for the treatment of Crohn's disease, with an ongoing Phase III study, (ii) RHB-105 - an oral combination therapy for Helicobacter pylori infection, with an ongoing Phase III study; (iii) RHB-106 - an encapsulated formulation for bowel preparation licensed to Salix Pharmaceuticals Ltd.; (iv) RHB-103 - an oral thin film formulation of rizatriptan for acute migraines with a U.S. NDA under FDA review and a European marketing application planned to be filed during Q3, 2014; (v) RHB-102 - a once-daily oral pill formulation of ondansetron for the prevention of nausea and vomiting, in advanced development stages for multiple indications and, (vi) RHB-101 - a once-daily oral pill formulation of the cardio drug carvedilol. For more information please visit: www.redhillbio.com
Zack's Research Initiates Coverage on Theralase (TLTFF) (TLT.V) With a Price Target of $1.00
Theralase Lights Up Cancer Therapeutics
Whitefish, MT / May 20, 2014 / Update: Zacks Small Cap Research recently initiated coverage of Theralase Technologies with a price target of $1.00 per share that represents a 270% premium to the May 6th stock price of $0.27 per share. The Full Zack’s Report can be read here. Investors in the cancer therapeutics space, including those in companies like Cell Therapeutics Inc. (CTIC) or Osiris Therapeutics Inc. (OSIR), may want to take a closer look at the company given these recent developments.
Cancer patients don’t have many good treatment options. Once the disease is detected, most oncologists will surgically remove as much as possible and then use powerful radiation and chemotherapy to kill as many cells in those areas as possible. The side effects from these treatments can be terrible and patients are at a higher risk of additional complications given the weakened state of the immune system.
Theralase Technologies Inc. (TLTFF) (TLT.V) aims to provide a better treatment option using the power of laser light and photodynamic compounds (“PDCs”). In this article, we’ll take a look at how these technologies could revolutionize cancer treatment as well as other areas like pain management.
SECFILINGS.COM Executive Interview | Theralase Technologies (TLTFF) []
Theralase Overcomes Key Hurdles
Theralase Technologies delivers light-sensitive PDCs directly into cancerous tumors, via injection, where they are selectively absorbed by cancer cells. A very specific type of laser light is then applied to the region via fiber optic wires, forcing the PDCs to become cytotoxic and inducing apoptosis – or cell death – in the cancer cells. Since no surgery is necessary, the process is more affordable and minimally invasive.
The company’s approach is unique in that it’s effective in hypoxic environments (low oxygen), seen in solid-core cancers like: brain, breast, lung and prostate and in hypoxic areas like bladder cancer. Hypoxic cancers are extremely aggressive, resistant to standard therapies, and are very difficult to destroy. Tumor hypoxia is also known to play a role in cancer metastasis and resistance to therapy.
The effectiveness of the approach has already been highlighted in numerous published studies. For example, a December 2013 study published in Photodiagnosis and Photodynamic Therapy found that the company’s TLD1411 and TDL1433 maintained photodynamic inactivation (“PDI”) potency under hypoxic conditions becoming even more effective in the low-oxygen environment.
Clear Pathway to Commercialization
Theralase Technologies has outlined a very clear path towards commercializing its unique technology platform with a uniquely qualified management team. President & CEO Roger Dumoulin-White founded the company back in 1995 and has 27+ years of senior management experience with private and public companies, while CSO Dr. Arkady Mandel was a key founder of therapeutic lasers in numerous clinical areas.
On April 3, 2014, the company announced that it executed a research agreement with Acadia University to supply PDCs necessary to commence toxicity studies and ramp up manufacturing. These steps are necessary to file Investigational New Drug (“IND”) applications with the U.S. FDA and Health Canada and begin Phase 1/2a human clinical trials for bladder cancer as early as Q1 2015.
The company hopes to expedite the process using the FDA’s new Breakthrough Therapy program initiated on July 9, 2012 with the Safety and Innovation Act. Management believes that the designation could lead to its PDC technology being available to bladder cancer patients as early as 2016.
Additional Play in Pain Management
Theralase Technologies’ superpulsed laser technology is already being used as a safe and effective way to eliminate pain, reduce inflammation, and accelerate tissue regeneration in nerve, muscle, and joint injuries. The company’s TLC-1000 is a best-in-class technology that has already helped millions of patients throughout Canada and there are plans to launch an even more effective technology, the next generation TLC-2000, in Q4 2014.
Using the technology, monochromatic laser light is delivered into the therapeutic window (wavelength range where laser light can be delivered deep into tissue without heat) in wavelengths ranging from 600 to 950 nanometers. Light particles from these lasers penetrate up to 10 centimeters into tissue and are absorbed into the elements of cell mitochondria, where they increase the rate of ATP production, nitric oxide production and rebalance what is called the sodium potassium pump. ATP production fuels the cells and actuates the healing process, nitric oxide production brings more blood, oxygen and fuel molecules to the injured area to further accelerate healing and rebalancing the sodium potassium pump eliminates pain. A very effective one, two, three punch for effective healing.
On April 15, 2014, the company announced the hiring of Mr. Derek Small as Director of Sales and Marketing to jumpstart revenues in these areas. With over 15 years of experience in both the U.S. and Canada, Mr. Small notably helped another U.S.-based aesthetic laser company grow sales from no revenue to $20 million in annual revenue within five years, taking increasingly senior roles.
Potential Investment Opportunity
Theralase Technologies represents an attractive investment opportunity for a variety of different reasons. In the cancer treatment space, the company’s unique approach could open the door to significant long-term revenue potential. Commercialization partnerships with major pharmaceutical companies in oncology, like GlaxoSmithKline plc. (NYSE:GSK), could also boost its near-term potential.
In the meantime, the company’s existing cold laser therapy division continues to generate revenue. The hiring of Mr. Small could significantly expand that revenue through 2014, particularly if his prior experience serves as any indicator. These revenues could make the stock attractive in the pain management space as an alternative to options like Pain Therapeutics Inc.’s (NASDAQ:PTIE) REMOXY.
GainClients, Inc.(GCLT) Signs Coldwell Banker Franchise as a Reseller of its SikkU Service
TUCSON, Ariz., May 20, 2014 /PRNewswire/ -- GainClients, Inc. (GCLT), announced that R&M Realty dba Coldwell Banker Premier Realty ("CBPR"), a company organized and existing under the laws of Nevada signed a Reseller Agreement to distribute GainClients' SikkU service.
CBPR will be introducing the SikkU Service to the mortgage industry as a purchase money solution initiative to increase a lender's capture and conversion of existing and new clients for more mortgage loans. With SikkU, banks and mortgage companies will have a comprehensive home search service that includes a suite of marketing features including a mobile app and the SikkU text messaging platform.
"We're excited that CBPR recognizes the mortgage industry's need for a new purchase money solution in the current real estate market and that we can provide it", stated Ray Desmond the company's CEO.
"Controlling the point of entry into the buy-sell event is critical to increasing market share in today's hyper-competitive environment. With SikkU, lenders will be able to provide their clients with valuable real estate information, increase their internal cross-selling opportunities and enhance their brand", stated Brian Krueger, SVP of Strategic Services for Coldwell Banker Premier Realty.
CBPR was purchased in 1998 and under new ownership and direction, increased the company's gross commission income by more than $35 million in less than ten years. In the past few years, CBPR ranked #8 in the Top-50 Companies for all of Coldwell Banker, out of over 1,200 companies, with their Sahara, NV Office recognized as the #1 office in Coldwell Banker's Western Region. CBPR has three offices in Southern Nevada (Summerlin, Henderson and Centennial Hills) and presently has over 225 agent affiliates.
About GainClients, Inc.
GainClients, Inc. trades on the OTC Market under the symbol GCLT. Its product, SikkU, is the first lead generation and marketing service that is integrated with local REALTOR® association data and that is based on a networking platform. GainClients generates revenue through monthly subscriptions from individual real estate, mortgage title and escrow professionals, along with real estate related organizations such as banks, credit unions, real estate and lender brokerages and title companies. The service is available in the following areas: AZ, ID, IL, NV, OR, TX and WA via the web, text and android and iOS applications. Learn more at www.sikku.com.
Levon Resources (TSX: LVN; OTCQX: LVNVF) Begins Trading on OTCQX®
NEW YORK, May 15, 2014 /PRNewswire/ -- OTC Markets Group Inc. (OTCQX: OTCM), operator of Open, Transparent and Connected financial marketplaces, today announced that Levon Resources Ltd. (TSX: LVN; OTCQX: LVNVF), a mid-tier mineral exploration company, has been approved to trade on OTCQX®, the best marketplace with qualified companies.
Logo - http://photos.prnewswire.com/prnh/20110118/MM31963LOGO
Levon begins trading today on OTCQX under the symbol "LVNVF." U.S. investors can find current financial disclosures and Real-Time Level 2 quotes for the company on www.otcmarkets.com.
"We are pleased to welcome Levon to the OTCQX marketplace," said R. Cromwell Coulson, President and CEO of OTC Markets Group. "Trading on OTCQX will enable Levon to leverage its existing Canadian disclosure to broaden its exposure to U.S. investors. We look forward to working with Levon as the company expands its visibility in the U.S. market."
"Trading on OTCQX is a natural step in the growth of Levon," commented Ron Tremblay, President and CEO of Levon Resources Ltd. "Levon is at an exciting stage in its development and rapid growth phase, and with the assistance of Euro Pacific Capital we look forward to elevating the awareness of the company to a broader U.S. shareholder base. With this new access, we are excited to start increasing our market visibility and sharing our vision with a larger audience of investors. We believe that Euro Pacific will broaden the company's access to both current and prospective U.S. shareholders. This should increase our exposure to U.S. investors with more efficient access and liquidity to our stock in the United States. We also believe that all shareholders will benefit from Euro Pacific's access to a larger number of retail and institutional investors."
Euro Pacific Capital, Inc. serves as Levon's Principal American Liaison ("PAL") on OTCQX, responsible for providing professional guidance on OTCQX requirements.
Levon Resources is exploring one of the world's largest silver resources at the company's 100%-owned Cordero Project in northwest Mexico. In less than four years, Levon has amassed a resource at Cordero containing 364 million ounces silver indicated plus 91 million ounces silver inferred. Further indicated resources of 945,000 ounces gold, 6.1 billion pounds zinc and 3.3 billion pounds lead have established Cordero as one of Mexico's premier polymetallic porphyry targets.
About OTC Markets Group Inc.
OTC Markets Group Inc. (OTCQX: OTCM) operates Open, Transparent and Connected financial marketplaces for 10,000 U.S. and global securities. Through our OTC Link® ATS, we directly link a diverse network of broker-dealers that provide liquidity and execution services for a wide spectrum of securities. We organize these securities into marketplaces to better inform investors of opportunities and risks – OTCQX®, The Best Marketplace; OTCQB®, The Venture Stage Marketplace; and OTC Pink®, The Open Marketplace. Our data-driven platform enables investors to easily trade through the broker of their choice at the best possible price and empowers a broad range of companies to improve the quality and availability of information for their investors. To learn more about how we create better informed and more efficient financial marketplaces,
Theralase (TSXV: TLT) Partners with Princess Margaret Cancer Centre
Toronto, Ontario / TNW-ACCESSWIRE / May 15, 2014 -- Theralase Technologies Inc. ("Theralase') (TSXV: TLT) (TLTFF: OTCBB) announced today that it has partnered with Princess Margaret Cancer Centre, University Health Network ("UHN") to complete preclinical research on its Photo Dynamic Compound (PDC) technology for the destruction of cancer.
Under the terms of the agreement, Theralase's scientific and engineering teams will work with UHN's scientific and medical cancer specialists to complete preclinical research for the anti-cancer technology in the destruction of cancer and to advance the technology to the clinical stage. Anticipated 2014 milestones include the destruction of bladder cancer in a rat model, verification of the lead PDC for bladder cancer, validation of manufactured PDC quality and toxicology analysis assistance.
Dr. Arkady Mandel, Chief Scientific Officer of Theralase stated, "I am delighted that we have partnered with UHN to complete this pivotal preclinical research. UHN is one of the top five cancer centres in the world and provides excellent clinical and scientific support to our existing teams to complete the preclinical work required to prepare us for a Phase 1/2a human clinical trial for bladder cancer.
Dr. Lothar Lilge, PhD, Senior Research Scientist at UHN stated, "The initial in-vitro and small animal in-vivo work using Theralase's anti-cancer PDC technology has been excellent, demonstrating elimination of a wide range of cancer cells at sub micromolar concentations (nanograms of PDC) when light activated and without toxicity in the absence of light. Eliminating subcutaneous tumours in in vivo small animals with this non-invasive and non-ionizing technology bodes very well for the anticipated clinical destruction of cancer in the future."
Dr. Michael Jewett MD, clinician investigator and uro-oncologist at Princess Margaret/UHN stated, "I am encouraged that Theralase has continued to pursue investigating the possibility of destroying bladder cancer with their anti-cancer PDC technology. Bladder cancer is a devastating disease with over 386,000 new cases annually worldwide and no new drug treatments approved since 1998. If, with the support of UHN, Theralase is able to prove its safety and efficacy in clinical trials, we have a game changer on our hands in the management and treatment of patients with bladder cancer."
Roger Dumoulin-White, President and CEO of Theralase stated that, "I am pleased that Theralase has chosen a strong partner like UHN to help us complete our preclinical research and help us to prepare for human clinical trials. UHN will be strategic for Theralase to help complete our preclinical work by early 2015 and allow us to commence human clinical trials with them and a large US cancer facility soon thereafter."
About Theralase Technologies Inc.
Theralase Technologies Inc. designs, manufactures and markets patented, superpulsed laser technology used in eliminating pain and destroying cancer. Theralase technology is safe and effective in eliminating pain, reducing inflammation and accelerating tissue regeneration of numerous nerve, muscle and joint conditions. Theralase is actively developing patented technology that is able to target and destroy cancers, bacteria and viruses when light activated
Altima (TSX VENTURE:ARH) Update Regarding Chambers Area Well and Pipeline Transfers
VANCOUVER, BRITISH COLUMBIA--(Marketwired - May 14, 2014) - Altima Resources Ltd. (TSX VENTURE:ARH)(FRANKFURT:AKC)(PINKSHEETS:ARSLF) announces that the Company has accepted the Transfer and Operatorship of three wells and two associated pipeline Licences from Unbridled Energy Corporation. The transfer is part of a process Altima has initiated to enable evaluating the on-stream potential of the subject wells. Altima holds an average Working Interest of 80.52% in the three wells being 90.34% in 3-17-41-11 W5M, 90.89% in 6-18-41-11 W5M, and 60.00% in 16-21-41-11 W5M.
A total of 1.93 kilometers of pipeline has been transferred and an additional 2.4 kilometers licensed for a future tie in of the 6-18 well to the 3-17 header. Altima has also undertaken an evaluation of constructing an estimated 3.37 kilometers of new pipeline from the 16-21 well to the header at 1-16-41-11 W5M which is part of the pipeline infrastructure Altima constructed in October 2013 in bringing the 14-15-41-11 W5M well on stream. The 16-21 well is completed and fracture stimulated in the Elkton formation.
The Company also plans to workover the 3-17 well and bring it back on-stream through its existing 1.9 km pipeline to the COPOL compressor at 9-4-41-11 which is connected to the Keyera Strachan sales point. An evaluation will be done on the 6-18 well to determine the feasibility of working over and tying in the Elkton zone and/or re-completing the well uphole.
The Company's mostly contiguous land base at Chambers-Ferrier totals twenty seven (27) sections (17,280 gross acres) with an approximate average working interest of 86% in 16 of the 27 sections and varying interests in eleven (11) wells.
Richard Switzer, CEO, President and a Certified Professional Geologist, is the Qualified Person under National Instrument 51-101 responsible for preparing and reviewing the data contained in this press release.
ON BEHALF OF THE BOARD
SIGNED: "Richard Switzer"
IntelGenx (IGXT) Reports Q1 2014 Results and Provides Corporate Development Update
SAINT LAURENT, Quebec, May 13, 2014 (GLOBE NEWSWIRE) -- IntelGenx Corp. (IGX.V) (IGXT) ("IntelGenx") today announced financial results for the three months ended March 31, 2014 and provided an update on corporate developments. All amounts are in U.S. Dollars, unless otherwise stated.
Corporate Development Update
Par Pharmaceutical, Inc.
On January 13, 2014 we announced the execution of a second development and commercialization agreement with Par Pharmaceutical, Inc. ("Par") for two new products utilizing our proprietary oral drug delivery platforms.
Under the terms of the agreement, Par has obtained certain exclusive rights to market and sell our products in the USA. In exchange we will receive upfront and milestone payments, together with a share of the profits upon commercialization. In accordance with confidentiality clauses contained in the agreement, the specifics of the products and financial terms remain confidential.
Anti-migraine VersaFilm(TM) product
On February 4, 2014 we, together with our co-development partner RedHill Biopharma Ltd. ("RedHill"), announced receipt of a Complete Response Letter ("CRL") from the U.S. Food and Drug Administration ("FDA") regarding the New Drug Application ("NDA") for our VersaFilm(TM) product for the treatment of acute migraines. The anti-migraine VersaFilm(TM) product is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.'s Maxalt(R).
A CRL is issued by the FDA's Center for Drug Evaluation and Research to inform companies that certain questions and deficiencies remain that preclude the approval of the application in its present form. The questions raised by the FDA in the CRL regarding the NDA for the anti-migraine VersaFilm(TM) product primarily relate to Chemistry, Manufacturing and Controls ("CMC") and to the packaging and labeling of the product. No questions or deficiencies were raised relating to the product's safety and the FDA's CRL does not require additional clinical studies.
On March 3, 2014 we, together with RedHill, announced the submission of a response to the FDA's CRL and on April 24, 2014 IntelGenx and RedHill (the "Companies"), reported that the FDA had acknowledged receipt of our response and has requested additional CMC data, which the Companies believe they can supply within several weeks based on available information.
The Companies further reported that a supplier of raw material for the anti-migraine VersaFilm(TM) product is currently holding compliance discussions with the FDA, which are independent of RedHill and IntelGenx and are not specific to our anti-migraine VersaFilm(TM) product. The Companies are diligently working on a variety of options to ensure continued supply of the raw material regardless of the result of these compliance discussions.
The Companies believe that FDA approval of the anti-migraine VersaFilm(TM) product NDA is subject to the satisfactory resolution of the remaining CMC questions, as well as securing a compliant source of the raw material. Therefore, IntelGenx and RedHill will continue to work with the FDA in order to submit all the data requested, and will provide an update as and when applicable.
On April 28, 2014 the Companies announced the commencement of a comparative bioavailability clinical study comparing the anti-migraine VersaFilm(TM) product to the European reference drug. The study is intended to support the planned submission of a European Marketing Authorization Application ("MAA") and follows a positive scientific advice meeting with the German Federal Institute for Drugs and Medical Devices ("BfArM") announced by RedHill in November 2013. This single-dose, crossover, comparative bioavailability study includes 26 healthy volunteers and is intended to evaluate and compare the relative bioavailability and to assess the bioequivalence of the anti-migraine VersaFilm(TM) product and the reference drug, Maxalt(R) lingua, marketed in Germany by Merck Sharp & Dohme GmbH.
Results of the bioavailability study are anticipated by June 2014. Subject to the results of the study and to the required regulatory process, and in light of the data from prior successful studies conducted with the anti-migraine VersaFilm(TM) product, the Companies plan to submit a European MAA in the third quarter of 2014, with Germany as the reference member state, under the European Mutual Recognition Procedure ("MRP").
Erectile Dysfunction VersaFilm(TM) product
On February 24, 2014 we announced the completion of a pilot biostudy with our proprietary VersaFilm(TM) tadalafil product for erectile dysfunction that indicated bioequivalence with the leading brand reference listed drug ("RLD") tadalafil product.
This was a randomized, two-period, two-way crossover study in healthy male subjects. The study was designed to determine whether VersaFilm(TM) tadalafil was bioequivalent as measured by industry standard pharmacokinetic measures of peak plasma concentration (Cmax) and area under the curve (AUC). The study results demonstrated that VersaFilm(TM) tadalafil was within an acceptable range of bioequivalency with the RLD on both of these measures.
Government Funding for CNS VersaFilm(TM) product
On April 30, 2014 we announced financial support from the National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP). In addition to advisory services and technological expertise, the funding provided by NRC-IRAP will support further development of a product for the treatment of central nervous system (CNS) diseases and disorders. The product will be based upon our proprietary, oral thin film, VersaFilm(TM), technology.
In order to maintain our competitive advantage, no specific details related to this project are being disclosed at this time.
U.S. patent allowances
On February 26, 2014 we announced receipt of a Notice of Allowance ("NOA") from the United States Patent and Trademark Office ("USPTO") for U.S. Patent Application Serial No. 11/647,033 entitled "Multilayer tablet" which covers the technology used in our hypertension product currently under development. A second NOA has been received for U.S. Patent Application Serial No. 11/782,838 entitled "Controlled-release pharmaceutical tablets" which is related to the drug delivery technology used in Forfivo XL(R), our first FDA-approved product currently commercialized in the U.S. These two NOA's conclude the examination of each U.S. patent application and will result in the issuance of two U.S. patents after administrative processes are completed.
On April 16, 2014 we announced receipt of a further NOA from the USPTO for U.S. Patent Application Serial No. 12/836,810 entitled "Oral mucoadhesive dosage form" which covers IntelGenx' proprietary AdVersa(TM) mucoadhesive drug delivery technology. This NOA concludes the examination of the U.S. patent application and will result in the issuance of a U.S. patent after the administrative process is completed.
Financial Results:
Cash on hand at March 31, 2014 increased to $5.2 million and compares with a cash balance of $5.0 million as at December 31, 2013. The increase in cash on hand at the end of Q1, 2014 relates to net cash provided by financing activities of $1.1 million (Q1, 2013 - $0.2 million), partly offset by net cash used in operating activities of $0.6 million (Q1, 2013 - $0.0 million), net cash used in investing activities of $0.1 million (Q1, 2013 - $0.1 million), and an unrealized foreign exchange loss of $0.2 million (Q1, 2013 - $0.0 million). The net cash provided by financing activities in Q1, 2014 consists of approximately $1.1 million in proceeds received from the exercise of warrants.
Revenue of $222 thousand during the quarter ended March 31, 2014 (Q1, 2013 - $157 thousand) primarily relates to revenue generated by Forfivo XL(R), our first FDA-approved product.
Total expenses in the first quarter of 2014 were $664 thousand compared with $643 thousand in the same period of 2013. The increase in R&D expenses relates to the costs of a pilot clinical study for our VersaFilm(TM) product for erectile dysfunction that indicated bioequivalence with the leading brand reference listed drug tadalafil product, partly offset by a reduction in R&D staff salaries.
The net loss decreased from $486 thousand in Q1, 2013 to a loss of $442 thousand in Q1, 2014. The loss per share was $0.01 in Q1, 2014 and $0.01 in Q1, 2013.
Highbank (TSX VENTURE:HBK) Compliments B.C. Government LNG Milestones
VANCOUVER, BRITISH COLUMBIA--(Marketwired - May 9, 2014) - Highbank Resources Ltd. (TSX VENTURE:HBK)(FRANKFURT:V7O) (the "Company" or "Highbank").
President Victor N. Bryant reports: "Highbank, and its board of Directors on behalf of the shareholders compliments B.C. Premier, Christy Clark; B.C. LNG Minister, Rich Coleman and their staff on an absolutely outstanding job in furthering the B.C. LNG build." "We British Columbians are being well served under Christy Clark's, Premiership." "Having some familiarity with seeing large scale projects through to completion I foresee many of these proposed projects building sufficient momentum to see them through to commercial fruition." "The milestones of the last 9 days are indicative to the Standing B.C. Governments, extraordinary efforts in building a strong economic future for British Columbia and Canada."
April 30, 2014 - Province opens doors to Asian investment in LNG. Launches 5th Trade mission to Malaysia, Singapore and Hong Kong May 02-09 2014. Rich Coleman: "By supporting the development of this new export industry, we are creating unprecedented economic opportunities for the people of British Columbia."
Story and Video link http://ow.ly/wDP7H
May 02, 2014 - B.C. LNG Minister Reports Grassy Point, Aurora LNG project obtains support from the National Energy Board. http://ow.ly/wDNWw LNG Minister Rich Coleman states, "Our government's strategy to build this new industry continues to gain momentum. This is now the ninth export licence to receive approval. We look forward to working alongside Aurora LNG as they continue to plan a project at Grassy Point near Prince Rupert following the signing of a sole proponent agreement with us last year."
May 05, 2014 - B.C. Government and PETRONAS commit to developing LNG Industry. From Kula Lumpur, Malaysia, Premier, Christy Clark States: "Our goal is to be the most competitive jurisdiction in the world for LNG, and build a sustainable industry that creates 100,000 jobs, and opportunities for generations to come - and we're gaining momentum every day."
Story and Video http://ow.ly/wDRjn
May 07, 2014 - Commitment between B.C. and Woodfibre advances LNG Woodfibre. Spokesperson, Imelda Tanoto. "Reaching this agreement with Premier Christy Clark is a strong signal to our company that the Government of British Columbia is committed to the success and viability of the LNG sector."
Story and Video http://ow.ly/wDF6n
Highbank Resources Ltd. has the distinct honour of being a guest exhibitor of LNG-Buy BC at the upcoming 2014 International LNG in B.C. Conference - May 21-23, 2014, being held at the B.C. Trade and Convention Center. Come visit with us at our booth # 903. To register http://ow.ly/wE10X.
On behalf of the Board of Directors of HIGHBANK RESOURCES LTD.
Victor N. Bryant, CEO/President
Altima (TSX VENTURE:ARH) Update Regarding Chambers 5-35-41-11 W5M Well and Pipeline
VANCOUVER, BRITISH COLUMBIA--(Marketwired - May 9, 2014) - Altima Resources Ltd. (TSX VENTURE:ARH)(PINKSHEETS:ARSLF)(FRANKFURT:AKC) announces that the Altima Chambers 5-35-41-11 W5M well (5-35 well) will be completed and the pipeline connecting the well to Altima's production infrastructure will commence operations within the next two weeks.
The 5-35 well will be fracture stimulated over multiple prospective zones. The operation is anticipated to take approximately 24 days, and will be timed such that the well can be brought on stream in conjunction with the Keyera Strachan facility turnaround. Altima will immediately commence construction of a 1.37 Kilometer 4 inch natural gas pipeline and facilities from the 5-35 well to a riser at 9-35-41-11 W5M. The new line will tie into Altima's existing Chambers North production and gathering system.
As reported in the Company's March 3 and March 17, 2014 News Releases, the 5-35 well is the second well drilled under Altima's Participation Agreement with Whistler Oil and Gas Pty. Ltd., and was drilled to a Total Depth of 3,158 meters and Rig Released on March 16, 2014. The 5-35 well is located approximately 1.1 kilometers south of the 15-35-41-11 W5M well (which was drilled, completed, and placed on production in 2013), and 4 kilometers to the north of the COPOL ET AL HZ CHAMBERS 14-15-41-11 W5M well (which was drilled and completed in 2012, and placed on production in 2013).
The Company's mostly contiguous land base at Chambers-Ferrier totals twenty seven (27) sections (17,280 gross acres) with an approximate average working interest of 86% in 16 of the 27 sections and varying interests in eleven (11) wells.
Richard Switzer, CEO, President and a Certified Professional Geologist, is the Qualified Person under National Instrument 51-101 responsible for preparing and reviewing the data contained in this press release.
ON BEHALF OF THE BOARD
Richard Switzer, CEO and President
Altima (TSX VENTURE:ARH) Intends to Complete Equity Financing for $12,500,000 at a Premium to Market and Consolidate Share Capital on an 8:1 Basis
VANCOUVER, BRITISH COLUMBIA--(Marketwired - May 5, 2014) -
NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES
Altima Resources Ltd. (TSX VENTURE:ARH) ("Altima" or the "Company") announces that it intends to complete a private placement for gross proceeds of $12,500,000 (the "Financing"), subject to acceptance by the TSX Venture Exchange. These funds will be raised by the issuance of 138,888,886 Units (the "Units") at a price of $0.09 per Unit (currently being a premium to the Company's market price), each Unit consisting of one common share and one-half share purchase warrant (the "Warrants"), each whole Warrant entitling the holder thereof to purchase one additional common share, exercisable for a period of one (1) year from the date of issuance at a price of $0.15 per share. The Units will be issued to five investors.
Proceeds raised from the Financing will be used to fund drilling and advancing development of oil and gas wells on the Company's assets towards commercial production, and for general working capital.
No finders' fees are being paid in connection with the Financing.
The Financing is expected to close on or about May 21, 2014, and is subject to certain conditions, including, but not limited to, receipt of acceptance from the TSX Venture Exchange.
8:1 Consolidation
Following closing of the Financing, the Company intends to consolidate its share capital on an 8 old shares for 1 new share basis, to be implemented by the Company's Board of Directors in its discretion, subject to receipt of acceptance from the TSX Venture Exchange ("TSX-V"). The Company does not intend to change its name in connection with the consolidation. The Company will disseminate a further News Release upon receipt of acceptance from the TSX-V, which will set out the Effective Date for the consolidation.
ON BEHALF OF THE BOARD
Joe DeVries, Director
Highbank Reports: Approvals & Updates-"Swamp Point North Aggregate Project"
VANCOUVER, BRITISH COLUMBIA--(Marketwired - May 1, 2014) - Highbank Resources Ltd. (TSX VENTURE:HBK)(FRANKFURT:V7O) (the "Company").
Mr. Victor N. Bryant, CEO reports:
On April 11, 2014 Highbank had the honour of hosting a meeting at its corporate office in Vancouver with representatives of the Nisga'a Nation. Attending the meeting were the Nisga'a Chief Administrator Officer - Les Clayton and Chief Councilor - Franklin Alexcee. Also in attendance was Peter Lambright, President of Hobiyee Management-Matrix Logistics & Hobiyee Management Ltd. http://ow.ly/wlBM6 and Michael Kenney, General Manager of Matrix Aviation Solutions http://ow.ly/wlFkY . Highbank's board was represented by CEO, Victor N. Bryant and CFO, Gary Musil.
As a result of the meeting a Memorandum of Understanding ("MOU") was signed between Hobiyee-Matrix Logistics, Hobiyee Management Ltd. ("HML") and Highbank Resources Ltd. The purpose of the MOU is to outline the relationship moving forward between the companies and principle agreements as follows:
- Highbank agrees to utilize services of HML, provide such services are on a competitive basis and recognizing the rights of other First Nations groups with traditional rights in the area. Some of the services may include: camp rentals and/or upgrading existing facilities; supplying local labour (ie. camp staff-cooks, medics); fuel supply; helicopter and barging support.
- HML will facilitate a relationship between the Company and the Nisga'a Village of Gingolx, B.C.
- Highbank and HML will help the Village of Gingolx, market and develop the feasibility of the Gingolx community granite quarry project.
On April 22, 2014, Highbank received written notice from Fisheries and Oceans Canada, that they have accepted our December 4, 2013, proposal to "Construct a barge loading facility, comprised of barge moorage, barge mooring dolphins and a pile supported aggregate conveyor, and barge landing ramp on Portland Canal". The acceptance was received from the Pacific Biological Station, Fisheries Protection Program, Pacific Region - Nanaimo, B.C.
On April 28, 2014, Highbank received verbal confirmation from the Canadian Coast Guard that the Nisga'a has no conditions as to the traversing of its traditional marine areas as a result of Highbank's barging activity.
Mr. Bryant further adds: "Highbank is in the final stages of achieving all other NoW permit requirements which will enable Highbank to commence site work this month, prior to production."
Other
The Company announces that it has granted 125,000 incentive stock options to consultants. Subject to the approval of the TSX Venture Exchange, each stock option is exercisable into one common share of the Company for a period of three years from the date of grant, at a price of $0.15 per share.
ON BEHALF OF THE BOARD OF DIRECTORS OF HIGHBANK RESOURCES LTD.
Theralase (TSXV: TLT) Releases 2013 Financials
Toronto, Ontario / TNW-ACCESSWIRE / April 30, 2014 / Theralase Technologies Inc. (herein "Theralase") (TSXV: TLT) (TLTFF: OTCBB) released its 2013 financial results today, demonstrating an increase in profitability by 24% year over year, while successfully advancing its patented next generation therapeutic laser and cancer destruction technologies.
Total revenue for the year ended December 31, 2013 decreased 34% from $1,824,313 to $1,203,620 year over year.
The net loss for the year ended December 31, 2013 was $1,152,209 (including $211,543 of net non-cash expenses) compared to a net loss of $1,509,569 in 2012 (including $322,915 of net non-cash expenses), demonstrating an improvement of 24% year over year.
The net loss is a reflection of the ongoing commitment of Theralase to invest in the next generation of therapeutic laser and cancer destruction technologies, from existing therapeutic laser sales.
Selling and marketing expenses decreased 31% from $626,380 to $433,622 for the same period in 2012. The decrease was due to reduced spending on salaries for sales personnel and a reduction in associated marketing costs.
Administrative expenses decreased 24% from $1,238,900 to $942,069 for the same period in 2012. The decrease in administrative expenditures was due to reductions in administrative personnel, stock based compensation and commercial rent.
Research and development costs decreased 40% from $873,335 to $527,233 for the same period in 2012. The decrease reflects the approaching completion of the patented next generation TLC-2000 therapeutic laser technology and the pending ramp-up in the research and development costs associated with the cancer destruction technology in 2014.
The Company is focused on achieving the following strategic initiatives in 2014:
-- Increasing product sales and market acceptance of the TLC-1000 laser technology in Canada, the US and international medical markets, supported by the latest independent scientific and clinical research, which continues to confirm that the Company's proprietary technology has a higher safety and effectiveness as compared to other competitive technologies.
-- Investing in scientific and clinical research aimed at unlocking the mechanisms of action as to how Theralase laser light can so dramatically heal tissue versus competitive technologies.
-- Launch its patented next generation TLC-2000 biofeedback laser technology in Canada and the US in 4Q2014.
-- Research and development of its patented Photo Dynamic Compound (PDC) technology proven effective pre-clinically in the destruction of cancer by completing preclinical research in 2014 and commencing a FDA Phase 1/2a human clinical trial in bladder cancer in 1Q2015.
Roger Dumoulin-White, President and CEO of Theralase stated that, "2013 was a pivotal year for Theralase, where we relocated our head office to a better corporate location, streamlined our operations and made advancements in both the therapeutic laser and anti-cancer divisions. 2014 will be a very exciting year for Theralase as we increase our revenues through expansion of our sales and marketing initiatives, launch our next generation therapeutic laser technology and prepare to commence human clinical trials in our anti-cancer division in early 2015. Due to the on-going requirement of capital to fund the Company's growth in 2014 in both divisions, the Company will continue to investigate financing options on both the debt and the equity side, in order to achieve its strategic initiatives and unlock shareholder value."
About Theralase Technologies Inc.
Theralase Technologies Inc. designs, manufactures and markets patented, superpulsed laser technology used in healing injured tissue and destroying cancer. Theralase technology is safe and effective in eliminating pain, reducing inflammation and accelerating tissue regeneration of numerous nerve, muscle and joint injuries. Theralase is actively developing patented technology that is able to target and destroy cancers, bacteria and viruses when light activated.
Levon (TSX:LVN) Intersects 308 m of 70.77 g/t Ag Eq Including 36 m of 255.96 g/t Ag Eq From Surface, in the Center of the Cordero Resource Chihuahua, Mexico
VANCOUVER, BRITISH COLUMBIA--(Marketwired - April 30, 2014) - Levon Resources Ltd. ("Levon" or "the Company") (TSX:LVN)(BERLIN:LO9)(FRANKFURT:LO9)(PINKSHEETS:LVNVF) is pleased to report final drill hole assays from the Phase 4 drilling completed February 13, 2014 on the recently acquired Aida claim (see news release dated July 10, 2013) at the Company's wholly owned Cordero project near Hidalgo Del Parral, Chihuahua, Mexico. Twenty four (24) core holes 13,072 metres ("m") were drilled on a 100 to 150 m line spacing drill grid, testing the Aida claim which is located in the center of the Cordero resource (Technical report dated July 31, 2012, as amended and restated May 10, 2013 ).
Assays from the first 14 holes of the drill program were reported previously (February 26, 2014 press release, as corrected in the April 28, 2014 press release).
The results from the remaining 10 holes confirm mineralization extends from surface and to depths of 700 to 1000+ m, revealing wide, higher grade mineralization within volcanic feeders beneath the Cordero Felsic Volcanic Dome Complex (the "Dome"). The drill results establish that the Dome is mushroom shaped and mineralized to the surface. The stem feeders appear to elongate northeast through the strike direction of the Dome, and extend through the 600 m strike length of the Aida claim. The feeders consist of mineralized dacite and rhyolite dikes, and composite stocks which are gradational with the upper reaches of the mineralized Dome.
Drilling Highlights
Hole C14-267.
Hole C14-267 is a vertical hole drilled down the feeder stem of the Dome on section 443,100 m E through the Dome cap mineralization, and returned 308 m of 70.77 grams per tonne silver equivalent (g/t Ag Eq) (or 1010.2 feet (ft) of 2.28 ounces per metric tonne (oz/t) Ag Eq) (from 12 m to 320 m hole depths) including 36 m of 255.96 g/t Ag Eq (or 118.1 ft. at 8.23 oz/t Ag Eq) (hole depths 236 m to 272 m).
Table 1. Hole C14-267 composited drill assay intersections.*
HoleID From
m To
m Interval
m Interval
ft g/t
Ag Eq. oz/t
Ag Eq. g/t
Ag g/t
Au %
Zn %
Pb
C14-267 12 320 308 1010.5 70.77 2.28 26.40 0.082 1.07 0.43
Including
C14-267 198 224 26 85.3 165.45 5.32 73.17 0.129 1.89 1.28
Including
C14-267 236 272 36 118.1 255.96 8.23 80.39 0.137 5.05 1.16
Including
C14-267 300 312 12 39.4 164.67 5.29 62.20 0.262 1.67 1.68
C14-267 384 456 72 236.2 46.73 1.50 14.44 0.02 0.65 0.50
C14-267 468 496 28 91.9 51.50 1.66 18.85 0.029 0.81 0.33
*(USD$6.00 NSR/t cutoff grade. Ag Eq calculated using $25/oz Ag, $1,000/oz Au, $1.00/lb Zn and Pb directly from the assays within the composited intervals).
Hole C14-266.
Hole C14-266 is collared on section 443,100 m E, 150 m south of C14-267 and is an angle hole (-60 degrees) drilled north intersecting 70 m of 26.11 g/t Ag Eq (229.6 ft of 0.84 oz/t Ag Eq) (0m to 70m hole depths) in the upper part of the Dome, and 268 m of 87.25 g/t Ag Eq (or 879 ft of 2.81 oz/t Ag Eq) (from 94 to 362 m) in the volcanic feeder beneath the Dome. The widest and highest grade intersection within the volcanic feeder in C14-266 is 46 m of 170.53 g/t Ag Eq (or 150.9 ft of 5.48 oz/t Ag Eq) (from 236m to 282m) with other wide 3+ oz/t Ag Eq intersections down hole (Table 2).
Table 2. Hole C14-266 composited drill assay intersections.*
HoleID From
m To
m Interval
m Interval
ft g/t
Ag Eq. oz/t
Ag Eq. g/t
Ag g/t
Au %
Zn %
Pb
C13-266 0 70 70 229.7 26.11 0.84 16.27 0.023 0.20 0.13
C13-266 94 362 268 879.3 87.25 2.81 37.42 0.067 0.99 0.73
Including
C13-266 116 142 26 85.3 119.94 3.86 59.87 0.052 1.22 0.90
Including
C13-266 172 228 56 183.7 101.06 3.25 50.54 0.065 0.86 0.89
Including
C13-266 236 282 46 150.9 170.53 5.48 64.26 0.134 2.27 1.41
Including
C13-266 294 312 18 59.1 193.65 6.23 75.59 0.16 2.27 1.81
C13-266 380 430 50 164.0 102.70 3.30 32.96 0.065 1.83 0.62
Including
C13-266 402 430 28 91.9 153.43 4.93 51.37 0.096 2.64 0.94
C13-266 448 462 14 45.9 74.97 2.41 30.54 0.019 0.99 0.60
*(USD$6.00 NSR/t cutoff grade. Ag Eq calculated using $25/oz Ag, $1,000/oz Au, $1.00/lb Zn and Pb directly from the assays within the composited intervals).
"Finding the mineralized volcanic feeder zones beneath the Cordero Volcanic Dome Complex, gives us a new perspective on the project. The feeders are higher grade, with some big geometry right in the middle of the existing resource, and are capped by nearly continuous mineralization that comes right to the surface. These results were a direct result of being able to purchase the Aida claim consolidating our 100 % ownership of the District," said Ron Tremblay, President, CEO. "The latest drill holes complete the Phase 4 discovery drilling at Cordero, we look forward to seeing how the results affect the global resource, and the modeled economics of the pit designs."
Geometry
The grid drilling indicates feeder zone map widths of about 130 m (425 ft) along the 443,100 m E drill section. Angle hole C13-257 is collared 300 m south of C14-266 and is -60 degrees drilled north along section 443,100 m E which intersected a southern part of the feeder. C13-257 returned 50 m of 150.89 g/t Ag Eq (or 164.0 ft. of 4.85 g/t Ag Eq) (270 to 320 m hole depths) and 72 m of 91.41 g/t Ag Eq (or 236.2 ft. of 2.94 oz/t Ag Eq) (334 m to 406 m hole depths) including 16 m of 268.2 g/t Ag Eq (or 52.5 ft. of 8.63 oz/t Ag Eq) (374 m to 390 m hole depths).
Hole C14-271. Hole C14-271 intersected the feeders about 160 m to the west on drill section 442,940 m E. Dome cap mineralization: 186 m of 52.71 g/t Ag Eq (or 610.2 ft of 1.69oz/t Ag Eq) (6 m to 192 m hole depths) and then intersected higher grade mineralization along the contact of the volcanic feeder zone with limestone host rocks over 32 m of 348 g/t Ag Eq (or 111.5 ft of 11.21 oz/t Ag Eq) (448 m to 482 m hole depths). The true width of the intersection is unknown.
Table 3. Hole C14-271 composited drill assay intersections.*
HoleID From
m To
m Interval
m Interval
ft g/t
Ag Eq. oz/t
Ag Eq. g/t
Ag g/t
Au %
Zn %
Pb
C14-271 6 192 186 610.2 52.71 1.69 26.98 0.087 0.36 0.45
C14-271 202 264 62 203.4 29.34 0.94 13.08 0.124 0.16 0.25
C14-271 290 308 18 59.1 16.90 0.54 6.17 0.04 0.21 0.13
C14-271 324 364 40 131.2 56.12 1.80 24.22 0.07 0.57 0.49
C14-271 448 482 34 111.5 348.57 11.21 161.02 0.176 3.63 2.95
Including
C14-271 460 480 20 65.6 570.08 18.33 262.96 0.257 5.99 4.84
*(USD$6.00 NSR/t cutoff grade. Ag Eq calculated using $25/oz Ag, $1,000/oz Au, $1.00/lb Zn and Pb directly from the assays within the composited intervals).
Hole C14-274. Hole C14-274 is a -70 degree angle hole drilled west from the C14-271 drill site on section 442,940 m E. C14-274 drilled across the contact of the Dome, and the Pozo de Plata Diatreme Complex portion of the resource drilling through the mineralized cap, and intersecting 230 m of 52.22 g/t Ag Eq (or 754.4 ft. of 1.68 opt Ag Eq) (10 m to 240 m hole depths), including higher grades in mineralized breccias within the Dome (e.g. 30 m of 112.01 g/t Ag Eq (or 98.4 ft. of 3.60 oz/t Ag Eq) (158m to 188 m hole depths) (Table 4).
Table 4. Hole C14-274 drill assay composites.*
HoleID From
m To
m Interval
m Interval
ft g/t
Ag Eq. oz/t
Ag Eq. g/t
Ag g/t
Au %
Zn %
Pb
C14-274 10 240 230 754.6 52.22 1.68 25.28 0.151 0.33 0.44
Including
C14-274 158 188 30 98.4 112.01 3.60 54.47 0.297 0.73 0.93
C14-274 288 312 24 78.7 68.78 2.21 32.37 0.243 0.31 0.66
C14-274 328 344.1 16.1 52.8 15.55 0.50 3.78 0.107 0.17 0.11
*(USD$6.00 NSR/t cutoff grade. Ag Eq calculated using $25/oz Ag, $1,000/oz Au, $1.00/lb Zn and Pb directly from the assays within the composited intervals).
Composite drill hole assays from the 24 hole drill program, drill maps and cross sections are posted on the Levon website for review (www.levon.com).
"The latest drill results are better than expected. Excellent down hole grade continuities of mineralization, are present in 22 of the 24 holes from surface. Wide, higher grade mineralized feeder zones in the center of the resource present a significant advance in the discovery drilling. Drill core geology and field evidence, indicate the Cordero resource is hosted within a chain of mineralized volcanoes, and related intrusives and diatremes that mineralized themselves during volcanism, forming locally mineralized constructional volcanic topography, which is still preserved. We believe these latest drill results are very positive for the project and its future," states Vic Chevillon, VP Exploration, Director.
Planned Resource Update
The drilling and 3D geologic modeling data are being assembled and forwarded to IMC for preparation of an updated Cordero resource estimate.
Assay Reporting
•The final lab assays for Ag, Au, Zn, Pb from the 2 m sawed and continuously sampled core samples are summarized in this release.
•Assays and calculated silver equivalent grams per metric tonne (g/t Ag Eq) are reported for the composited drill intersections in metres (m) and also in feet (ft), and troy ounces per metric tonne (oz/t Ag Eq).
•Drill hole assay composites were calculated using the metal prices and cut offs that Independent Mining Consultants (IMC), and M3 Engineering and Technology (M3) used in their calculation of the Cordero resource, (see July 31, 2012 technical report, as amended and restated May 10, 2013) and modeling in the Preliminary Economic Analysis (PEA) (see March 12, 2012 PEA, as amended and restated May 8, 2013). The PEA provides the details of the NSR/t cutoff grade modeling. Management believes the metal prices used in the PEA continue to be realistic long term estimates, and the prices used are: USD$25/oz Ag, $1,000/oz Au, $1.00/ Pb Zn and Pb.
•Composite intervals were selected using a USD $6 NSR/t cut-off which equates to about 10 g/t Ag Eq. Minimum down hole grade continuity is 10 m in any of the composites.
•The composites were calculated directly from the assays and represent in-situ Ag Eq.
Qualified Person
Vic Chevillon, AIPG QPG # 11054, the Company's VP, Exploration and a qualified person as such term is defined in NI 43-101 of the Canadian Securities Administrators has reviewed and approved this news release.
About Levon Resources
Levon is a well-funded gold and precious metals exploration Company, exploring the company's 100% owned flagship Cordero bulk tonnage silver, gold, zinc, and lead project near Hidalgo Del Parral, Chihuahua, Mexico.
Levon's most recent mineral resource estimate is contained in a technical report prepared by IMC titled "Cordero Project June 2012 Mineral Resource Update, Chihuahua, Mexico" dated July 31, 2012, as amended and restated May 10, 2013,
IntelGenx (IGXT) Announces Government of Canada Funding for CNS VersaFilm(TM) Project
Saint Laurent, Quebec--(Newsfile Corp. - April 30, 2014) - IntelGenx Corp. (TSXV: IGX) (OTCQX: IGXT) ("IntelGenx"), a Canadian drug delivery company focusing on oral drug delivery, today announced financial support from the National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP). In addition to advisory services and technological expertise, the funding provided by NRC-IRAP will support further development of a product for the treatment of central nervous system (CNS) diseases and disorders. The product will be based upon IntelGenx' proprietary, oral thin film, VersaFilm™, technology.
"We are extremely pleased to have support from NRC-IRAP for this project", said Rajiv Khosla, IntelGenx' President and Chief Executive Officer. "This is further testimony of our scientific innovation and expertise, which we believe will enable us to develop a new therapeutic entity offering a treatment benefit to certain CNS patients in the future."
In order to maintain IntelGenx' competitive advantage, no specific details related to this project are being disclosed at this time.
About IntelGenx:
IntelGenx is a drug delivery company focused on the development of oral controlled-release products as well as novel rapidly disintegrating delivery systems. IntelGenx uses its unique multiple layer delivery system to provide zero-order release of active drugs in the gastrointestinal tract. IntelGenx has also developed novel delivery technologies for the rapid delivery of pharmaceutically active substances in the oral cavity based on its experience with rapidly disintegrating films. IntelGenx' development pipeline includes products for the treatment of indications such as severe depression, hypertension, erectile dysfunction, migraine, insomnia, CNS indications, idiopathic pulmonary fibrosis, oncology and pain, as well as animal health products.
Levon (TSX:LVN) Corrects Silver Equivalent Calculations in February 26, 2014 Press Release
VANCOUVER, BRITISH COLUMBIA--(Marketwired - April 28, 2014) - Levon Resources Ltd. ("Levon" or "the Company") (TSX:LVN) (PINKSHEETS:LVNVF) (BERLIN:LO9) (FRANKFURT:LO9) has identified calculation errors in the silver equivalent (Ag Eq) values for the composited drill hole intersections reported in its press release of February 26, 2014 (the "Press Release"). The silver equivalent calculations contained in the Press Release understated the actual calculated silver equivalent for the reported drill hole composites by approximately 5.4% due to an error in the metal prices used in the calculation.
The Ag Eq values in the Press Release were presented in a series of five tables, and certain of these values were mentioned in the accompanying text in the Press Release. The correct values appear in the tables below and will be posted for all the holes on the Levon website (www.levon.com). The corrected composite widths are unchanged and are reported in metres (m) and feet (ft), and calculated Ag Eq in grams per ton (g/t) Ag Eq, and ounces per ton (oz/t) Ag Eq.
To view Tables 1 - 5 that are associated with this release, please visit the following link: http://media3.marketwire.com/docs/941878-t1-5.pdf
Assay Reporting
•The final lab assays for Ag, Au, Zn, and Pb from the 2 m sawed and continuously sampled core intercepts are summarized in this press release.
•Assays and calculated silver equivalent grams per metric tonne (g/t Ag Eq) are reported for the composited drill intersections in metres (m) and also in feet (ft), and troy ounces per metric tonne (oz/t Ag Eq).
•Drill hole assay composites were calculated using the metal prices and cut offs that Independent Mining Consultants (IMC) and M3 Engineering and Technology (M3) used in their calculation of the Cordero resource, (see July 31, 2012 technical report, as amended and restated May 10, 2013) and modeling in the Preliminary Economic Analysis (PEA) (see March 12, 2012 PEA, as amended and restated May 8, 2013). The PEA provides the details of the NSR/t cutoff grade modeling. Management believes the metal prices used in the PEA continue to be realistic long term estimates, and the prices used are: USD$25/oz Ag, $1,000/oz Au, $1.00/ Pb Zn and Pb.
•Composite intervals were selected using a USD $6 NSR/t cutoff, which equates to about 10 g/t Ag Eq. Minimum down hole grade continuity is 10 m in any of the composites.
•The composites were calculated directly from the assays and represent in-situ Ag Eqs.
Qualified Person
Vic Chevillon, AIPG QPG # 11054, the Company's VP, Exploration and a qualified person as such term is defined in NI 43-101 of the Canadian Securities Administrators has reviewed and approved this news release.
About Levon Resources
Levon is a well-funded gold and precious metals exploration Company, exploring the company's 100% owned flagship Cordero bulk tonnage silver, gold, zinc, and lead project near Hidalgo Del Parral, Chihuahua, Mexico.
Levon's most recent mineral resource estimate is contained in a technical report prepared by IMC titled "Cordero Project June 2012 Mineral Resource Update, Chihuahua, Mexico" dated July 31, 2012, as amended and restated May 10, 2013,
IntelGenx ( IGXT ) and RedHill Biopharma Announce Commencement of a Bioavailability Study With Anti-Migraine VersaFilm(TM) Product to Support European Marketing Application Planned for Q3/2014
SAINT LAURENT, Quebec, April 28, 2014 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) ("IntelGenx"), a Canadian drug delivery company focused on oral drug delivery, together with RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) ("RedHill"), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage proprietary drugs, today announced the commencement of a comparative bioavailability clinical study comparing their anti-migraine VersaFilm™ Product to the European reference drug. The study is intended to support the planned submission of a European Marketing Authorization Application ("MAA") for the anti-migraine VersaFilm™ Product, a proprietary oral thin film formulation of rizatriptan for the treatment of acute migraines.
The comparative bioavailability study follows a positive scientific advice meeting with the German Federal Institute for Drugs and Medical Devices ("BfArM") announced by RedHill in November 2013. This single-dose, crossover, comparative bioavailability study includes 26 healthy volunteers and is intended to evaluate and compare the relative bioavailability and to assess the bioequivalence of the anti-migraine VersaFilm™ Product and the reference drug, Maxalt® lingua, marketed in Germany by MSD SHARP & DOHME GMBH.
Results of the bioavailability study are anticipated by June 2014. Subject to the results of the study and to the required regulatory process, and in light of the data from prior successful studies conducted with the anti-migraine VersaFilm™ Product, IntelGenx and RedHll plan to submit a European MAA in the third quarter of 2014, with Germany as the reference member state, under the European Mutual Recognition Procedure ("MRP").
IntelGenx and RedHill previously conducted a successful bioavailability study which demonstrated the required U.S. Food and Drug Administration ("FDA") criteria for therapeutic bioequivalence between the anti-migraine VersaFilm™ soluble oral thin film product and the U.S. reference drug, Maxalt-MLT®. Following the successful bioequivalence study, IntelGenx and RedHill announced in 2013 the submission to the FDA and acceptance for review of a New Drug Application ("NDA") seeking marketing approval of the anti-migraine VersaFilm™ Product. Following a Complete Response Letter ("CRL") received from the FDA in February 2014, which raised questions primarily related to Chemistry, Manufacturing and Controls ("CMC"), IntelGenx and RedHill recently reported that they believe that FDA approval of the anti-migraine VersaFilm™ Product NDA is subject to the satisfactory resolution of the remaining CMC questions, as well as securing a compliant source of the raw material. Accordingly, the companies continue to work with the FDA in order to address and resolve all remaining CMC questions and to secure a compliant source of the raw material.
About the VersaFilm™ Oral Film Product:
The product is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.'s Maxalt®. Rizatriptan is considered one of the most effective oral triptans, a class of molecules that constrict blood vessels in the brain to relieve swelling and other migraine symptoms. The worldwide annual sales of triptans were estimated to have exceeded $1 billion in 20131.
The product is based on IntelGenx' proprietary "VersaFilm™" technology. It dissolves rapidly in the mouth, leading to the absorption of the drug through the gastro intestinal track and into the bloodstream. The administration method of the oral thin film does not require the patient to swallow a pill or consume water, and presents a potentially attractive therapeutic alternative for many migraine patients, including those who suffer from migraine-related nausea, estimated at approximately 80% of the total migraine patient population2.
About IntelGenx:
IntelGenx is a drug delivery company focused on the development of oral controlled-release products as well as novel rapidly disintegrating delivery systems. IntelGenx uses its unique multiple layer delivery system to provide zero-order release of active drugs in the gastrointestinal tract. IntelGenx has also developed novel delivery technologies for the rapid delivery of pharmaceutically active substances in the oral cavity based on its experience with rapidly disintegrating films. IntelGenx' development pipeline includes products for the treatment of indications such as severe depression, hypertension, erectile dysfunction, migraine, insomnia, CNS indications, idiopathic pulmonary fibrosis, oncology and pain, as well as animal health products. More information is available about the company at www.intelgenx.com.
About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) is an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, proprietary formulations and combinations of existing drugs for the treatment of inflammatory and gastrointestinal diseases, including cancer and related conditions. RedHill's current pipeline of proprietary products includes: (i) RHB-104 - an oral combination therapy for the treatment of Crohn's disease, with an ongoing Phase III study, (ii) RHB-105 - an oral combination therapy for Helicobacter pylori infection, with an ongoing Phase III study; (iii) RHB-106 - an encapsulated formulation for bowel preparation licensed to Salix Pharmaceuticals Ltd.; (iv) RHB-103 - an oral thin film formulation of rizatriptan for acute migraines with a U.S. NDA under FDA review; (v) RHB-102 - a once-daily oral pill formulation of ondansetron for the prevention of nausea and vomiting, in advanced development stages for multiple indications and, (vi) RHB-101 - a once-daily oral pill formulation of the cardio drug carvedilol.
IntelGenx (IGXT) and RedHill Biopharma Provide an Update on FDA's Ongoing Review of the NDA for Migraine VersaFilm(TM) Product
Saint Laurent, Quebec--(Newsfile Corp. - April 24, 2014) - IntelGenx Corp. (TSXV: IGX) (OTCQX: IGXT) ("IntelGenx"), a Canadian drug delivery company focusing on oral drug delivery, together with RedHill Biopharma Ltd. (NASDAQ: RDHL; TASE: RDHL) ("RedHill"), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage proprietary drugs, today reported that the U.S. Food and Drug Administration ("FDA") acknowledged receipt of their response to the Complete Response Letter ("CRL") for the VersaFilm™ Oral Film Product New Drug Application ("NDA") and has requested further clarifications. The VersaFilm™ Oral Film Product is a proprietary oral thin film formulation of rizatriptan for the treatment of acute migraines.
IntelGenx and RedHill (the "Companies") reported on March 3, 2014 that they had submitted their response to the FDA's CRL for the VersaFilm™ Oral Film Product NDA, which had raised questions primarily related to Chemistry, Manufacturing and Controls (CMC). In response, the FDA has requested from the Companies additional CMC data, which the Companies believe they can supply within several weeks based on available information.
The Companies further report that a supplier of raw material for the VersaFilm™ Oral Film Product is currently holding compliance discussions with the FDA, which are independent of RedHill and IntelGenx and are not specific to the VersaFilm™ Oral Film Product. The Companies are diligently working on a variety of options to ensure continued supply of the raw material regardless of the result of these compliance discussions.
The Companies believe that FDA approval of the VersaFilm™ Oral Film Product NDA is subject to the satisfactory resolution of the remaining CMC questions, as well as securing a compliant source of the raw material. Therefore, IntelGenx and RedHill continue to work with the FDA in order to submit all the data requested, and will provide an update as and when applicable.
About the VersaFilm™ Oral Film Product:
The product is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.’s Maxalt®. Rizatriptan is considered one of the most effective oral triptans, a class of molecules that constrict blood vessels in the brain to relieve swelling and other migraine symptoms. The worldwide annual sales of triptans were estimated to have exceeded $1 billion in 20131.
The product is based on IntelGenx' proprietary "VersaFilm™" technology. It dissolves rapidly in the mouth, leading to the absorption of the drug through the gastro intestinal track and into the bloodstream. The administration method of the oral thin film does not require the patient to swallow a pill or consume water, and presents a potentially attractive therapeutic alternative for many migraine patients, including those who suffer from migraine-related nausea, estimated at approximately 80% of the total migraine patient population2.
About IntelGenx:
IntelGenx is a drug delivery company focused on the development of oral controlled-release products as well as novel rapidly disintegrating delivery systems. IntelGenx uses its unique multiple layer delivery system to provide zero-order release of active drugs in the gastrointestinal tract. IntelGenx has also developed novel delivery technologies for the rapid delivery of pharmaceutically active substances in the oral cavity based on its experience with rapidly disintegrating films. IntelGenx’ development pipeline includes products for the treatment of indications such as severe depression, hypertension, erectile dysfunction, migraine, insomnia, CNS indications, idiopathic pulmonary fibrosis, oncology and pain, as well as animal health products. More information is available about the company at www.intelgenx.com.
About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ: RDHL) (TASE: RDHL) is an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, proprietary formulations and combinations of existing drugs for the treatment of inflammatory and gastrointestinal diseases, including cancer and related conditions. RedHill’s current pipeline of proprietary products includes: (i) RHB-104 - an oral combination therapy for the treatment of Crohn's disease, with an ongoing Phase III study, (ii) RHB-105 - an oral combination therapy for Helicobacter pylori infection, with an ongoing Phase III study; (iii) RHB-106 - an encapsulated formulation for bowel preparation licensed to Salix Pharmaceuticals Ltd.; (iv) RHB-103 - an oral thin film formulation of rizatriptan for acute migraines with a U.S. NDA under FDA review; (v) RHB-102 - a once-daily oral pill formulation of ondansetron for the prevention of nausea and vomiting, in advanced development stages for multiple indications and, (vi) RHB-101 - a once-daily oral pill formulation of the cardio drug carvedilol.
Theralase (TSXV: TLT) Anti-Cancer Technology Validated at International Conference
Toronto, Ontario / TNW-ACCESSWIRE / April 24, 2014 / Theralase Technologies Inc. ("Theralase') (TSXV: TLT) (TLTFF: OTCBB) announced today new research on its Photo Dynamic Compound (PDC) technology, proven effective in the destruction of bacteria and cancer, has been peer reviewed and approved for presentation at the 16th Annual Laser Optics International Conference to be held in June 2014.
The new research scientifically proves that Theralase's patented PDC technology can be activated by Near Infrared (NIR) laser light destroying cancer cells that reside deep into tissue, providing a higher kill rate in a single Photo Dynamic Therapy (PDT) treatment, than previously possible, setting a new standard in the industry. The scientific and medical community considers the research pivotal because the Theralase PDCs are able to provide a solution to a problematic issue in cancer treatment, the ability to destroy cancerous tumours via PDT deep into tissue.
Cancer is a major worldwide disease, causing great threats to human health. Tumour recurrence, metastasis (spread of cancer to distant body parts) and drug resistance are making the disease untreatable in many instances. There is therefore an urgent need to develop technology that is effective in destroying cancer before it has an opportunity to metastasize to distant body parts and render the patient incurable. Providing a technology that is able to eliminate ongoing cancer proliferation and destroy deep seated tumours with a higher kill rate in a single PDT treatment is ground breaking.
Dr. Arkady Mandel, Chief Scientific Officer of Theralase stated, "Conventional cancer therapies, including chemotherapy and radiation therapy, have many limitations such as toxic side effects, drug resistance and the fact that they quite often fail to completely destroy the tumour. PDT utilizes a class of minimally invasive PDCs with many advantages such as an ability to administer the treatment with minimal side effects, improved selectivity to target only the cancer cells and virtually zero toxicity to the body; however, light penetration is one of the major challenges in PDT. Light in the UV to visible range (300 to 700 nm) has limited tissue penetration depth restricting the therapeutic efficacy of PDT for large or deep tumours for competitive PDCs. The NIR window in the range of 700 to 970 nm, in which biological tissues have minimal light absorption, is ideal for targeted cancer therapy. Activation of the Theralase PDCs by NIR light now addresses this issue. Therefore the results of our preclinical research are of great scientific and potential clinical significance."
Roger Dumoulin-White, President and CEO of Theralase stated that, "I am encouraged that the latest Theralase anti-cancer research continues to receive such high accolades from the international scientific and medical community. This validation of our technology from some of the most well known experts in the field supports the magnitude of our research and the fact that we are breaking new ground in cancer research. By being able to target cancer cells in deeper tissue than currently available allows Theralase the ability to use our patented technology to target cancer regardless of where it may lurk in the body."
About Theralase Technologies Inc.
Theralase Technologies Inc. designs, manufactures and markets patented, superpulsed laser technology used in eliminating pain and destroying cancer. Theralase technology is safe and effective in eliminating pain, reducing inflammation and accelerating tissue regeneration of numerous nerve, muscle and joint conditions. Theralase is actively developing patented technology that is able to target and destroy cancers, bacteria and viruses when light activated
Theralase (TSXV: TLT) Research Accepted at International Conference
(via Thenewswire.ca)
Toronto, Ontario / TNW-ACCESSWIRE / April 22, 2014 / Theralase Technologies Inc. (TSXV: TLT) (TLTFF: OTCBB) announced today that its Photo Dynamic Compound (PDC) technology, proven effective in the destruction of bacteria and cancer, has been peer reviewed and approved for presentation at the renowned International Conference on Laser Applications in Life Sciences to take place in Ulm, Germany in June 2014.
Theralase's ability to destroy two types of bacteria (Staphylococcus aureus and Methicillin Resistant Staphylococcus aureus (MRSA)) up to 99.99999% with a new class of PDCs has caught the attention of the global scientific and medical community after recent publication in the journal Photodiagnosis and Photodynamic Therapy.
The latest Theralase research is considered pivotal by the international community because the PDCs were able to destroy two types of bacteria in both normal and low oxygenated tissue in nanomolar concentrations (micrograms of the PDCs were lethal to bacteria when light activated) and were proven especially effective in low oxygen environments, where certain types of bacteria and cancer thrive.
Dr. Arkady Mandel, Chief Scientific Officer of Theralase stated that, "Theralase's PDC technology addresses the challenge of bacteria that develop an immunity to destruction due to an acquired resistance to treatment, such as antibiotic drugs. The latest research confirms that the Theralase PDCs are a reliable alternative to antibiotics and have none of the acquired resistance limitations. This new approach provides a novel and effective treatment to destroying bacteria by improving selectivity, reducing treatment time and improving safety for clinical applications, which is critical for a broad international acceptance of the technology. Moreover, the fact that the Theralase PDCs are effective in low oxygen and have a higher stability than FDA approved PDCs may have a tremendous impact in limiting the further spread of antibiotic-resistant strains of bacteria and simultaneously provide superior health care worldwide."
Roger Dumoulin-White, President and CEO of Theralase stated that, "I am delighted that our research in PDCs has attracted the international attention of the scientific and medical community. By being extremely effective in microgram concentrations, Theralase now has the opportunity for early partnership with large pharmaceutical organizations interested in alternatives to antibiotics for bacteria destruction. This is a billion dollar market in need of technology that is able to eliminate the bacterial load quickly and effectively, while minimizing risk to the patient."
About Theralase Technologies Inc.
Theralase Technologies Inc. designs, manufactures and markets patented, superpulsed laser technology used in eliminating pain and destroying cancer. Theralase technology is safe and effective in eliminating pain, reducing inflammation and accelerating tissue regeneration of numerous nerve, muscle and joint conditions. Theralase is actively developing patented technology that is able to target and destroy cancers, bacteria and viruses when light activated.
IntelGenx (OTCQX:IGXT) Announces Receipt of an Additional U.S. Patent Allowance Related to Proprietary Technology
SAINT LAURENT, Quebec, April 16, 2014 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) ("IntelGenx"), a Canadian drug delivery company focusing on oral drug delivery, today announced that it has received a Notice of Allowance ("NOA") from the United States Patent and Trademark Office ("USPTO") for U.S. Patent Application Serial No. 12/836,810 entitled "Oral mucoadhesive dosage form" which covers IntelGenx' proprietary AdVersa™ mucoadhesive drug delivery technology. This NOA concludes the examination of the U.S. patent application and will result in the issuance of a U.S. patent after the administrative process is completed.
"This patent allowance by the USPTO is another important achievement in protecting the innovation and commercial potential of IntelGenx drug delivery technologies and products," said Rajiv Khosla, IntelGenx' President and Chief Executive Officer. "This NOA is the latest example of how our scientific innovation continues to establish IntelGenx as a leader in pharmaceutical drug delivery."
About IntelGenx:
IntelGenx is a drug delivery company focused on the development of oral controlled-release products as well as novel rapidly disintegrating delivery systems. IntelGenx uses its unique multiple layer delivery system to provide zero-order release of active drugs in the gastrointestinal tract. IntelGenx has also developed novel delivery technologies for the rapid delivery of pharmaceutically active substances in the oral cavity based on its experience with rapidly disintegrating films. IntelGenx' development pipeline includes products for the treatment of indications such as severe depression, hypertension, erectile dysfunction, migraine, insomnia, CNS indications, idiopathic pulmonary fibrosis, oncology and pain, as well as animal health products. More information is available about the company at www.intelgenx.com
Skyharbour Resources Ltd. (TSX VENTURE:SYH) Western Athabasca Syndicate Provides Drill Program Update at Preston Property: Discovers Elevated Radioactivity and Expands Drilling at Swoosh Target
VANCOUVER, BRITISH COLUMBIA--(Marketwired - April 15, 2014) - Skyharbour Resources Ltd. (TSX VENTURE:SYH)(PINKSHEETS:SYHBF)(FRANKFURT:SC1N) ("Skyharbour") is pleased to provide an update at its ongoing first-phase diamond drill program on its flagship Preston Uranium Property (the "Property") in the southwest Athabasca Basin. The Western Athabasca Syndicate (the "Syndicate") has drilled five holes thus far for a total of 986 metres with three to four additional holes planned.
All five of the holes intersected a broad, hydrothermally altered and reactivated, structural zone. Three holes returned elevated radioactivity. As a result of these highly encouraging early findings, the Syndicate has decided to increase the budget and expand the testing of the Swoosh target. The additional drilling on this target will continue until late April. Drilling is planned to recommence in early to mid-May after breakup to test the CHA and Fin targets.
The initial five drill holes tested the Swoosh target, a six-kilometre long corridor consisting of geophysically anomalous areas as defined by gravity, magnetic and EM surveys, coincident with surficial geochemical anomalies. Four holes were completed down to depths of between 200 and 275 metres while the fifth hole was abandoned due to poor drilling conditions. Overburden depth varies from 4 to 38 metres and immediately overlies basement rock.
Preston Property - Swoosh Target Map:
http://skyharbourltd.com/_resources/maps/SYH_Swoosh_Drill_Locations.jpg
Three of the holes at Swoosh intersected zones of elevated radioactivity as defined by a downhole gamma probe with the best results to date occurring in hole PN14003 which contained several radioactive intervals; the most notable being 802 counts per second (cps) over 1.95 metres from 186.68 to 188.63 metres downhole in a background of 80 to 100 cps. The initial three holes also intersected multiple graphitic units within sheared and altered basement lithologies. The alteration commonly consists of pervasive chlorite, hematite and clay development; features which are associated with uranium mineralization in the Athabasca Basin. A review of final assays and geochemistry will be carried out upon receipt of results expected in May.
All holes were angle holes, drilled at -45 to -50 degrees. They were radiometrically surveyed using a RS-230 gamma-ray spectrometer, and a Mount Sopris 2PGA-1000 downhole natural gamma probe. Natural gamma radiation in drill core reported in this news release was measured in counts per second (cps). All intersections are downhole and core interval measurements and true thicknesses are yet to be determined. The reader is cautioned that a total counts gamma probe reading is the result of natural gamma radiation that may come from various sources including cosmic radiation, thorium, potassium and uranium and its radioactive decay products. CPS values cannot be certain to correlate with uranium grades of the rock but are a general guide of the radioactivity of minerals present in rock placed in proximity to the instrument.
The Syndicate's Technical Team considers these findings in the early stages of the first drill program to be a significant breakthrough towards locating shallow uranium mineralization, and have decided to expand the initial drill plan at the Swoosh target as a result. Two to three additional holes will be drilled at Swoosh before breakup at the end of April with drilling to recommence in early May.
Preston Uranium Property Map and Regional Exploration Corridors:
http://skyharbourltd.com/_resources/SYH_Regional_Corridors.jpg
The three initial target areas, out of a growing target base currently standing at fifteen, were selected by the Syndicate's Technical Committee for drilling based on encouraging fieldwork results and coincident anomalies from ground gravity, airborne and ground EM and magnetics (graphitic conductors and structures), radon, soil, biogeochem, lake sediment, prospecting and geological mapping surveys. This drill campaign represents the first modern-day drill exploration program on the Preston Uranium Property with follow up programs planned for later this year given the encouraging results to date.
Jordan Trimble, President and CEO of Skyharbour Resources, states: "We are very excited with the early findings in this ongoing first phase of drilling and are planning to extend the program into May as a result. The visual signatures and elevated radioactivity seen in the core from these first few holes confirm the prospectivity of the Swoosh target and illustrate the strong discovery potential at the Preston Property."
The Preston Uranium Property:
The 246,643 hectare Preston Uranium Property is the largest individual property proximal to Fission Uranium Corp.'s Patterson Lake South ("PLS") high-grade uranium discovery and the recent discovery made by NexGen Energy on the Rook 1 Project (see NexGen's news release dated Feb. 19, 2014). The Syndicate is the largest land tenure holder in the southwest Athabasca Basin region including properties strategically situated to the southwest and to the northeast of the PLS and NexGen discoveries.
Over $2.5 million dollars in exploration has been carried out to date by the Syndicate on the Preston property and many priority targets remain for further follow up with both fieldwork and drill testing. The Syndicate continues to employ a systematic, proven exploration methodology that has led to numerous uranium discoveries in the region and throughout the Athabasca Basin. This has been very effective in identifying numerous high-quality targets at Preston with similar geological features and exploratory indicators as those at the nearby PLS and NexGen discoveries as well as other deposits in the Athabasca Basin.
About the Western Athabasca Syndicate:
The Western Athabasca Syndicate is a strategic partnership formed between Skyharbour, Athabasca Nuclear, Lucky Strike and Noka to explore and develop a 287,130 hectare suite of uranium properties that is the largest land position along the highly prospective margin of the Western Athabasca Basin controlled by a single group. Under the terms of the agreement, each of the four companies has an option to earn 25% of the five uranium properties comprising the Western Athabasca Syndicate Partnership by making a series of cash payments, share payments, and incurring their pro-rata amount of the total $6,000,000 in exploration expenditures over the two-year earn-in term of the agreement. The properties were acquired for their proximity to the PLS discovery and interpreted favourable geology for the occurrence of PLS style uranium mineralization. The bulk of the Syndicate land package is bisected by all-weather Highway 955 which runs north through the PLS discovery on to the former Cluff Lake uranium mine.
The Athabasca Basin of Saskatchewan hosts the world's largest and richest high-grade uranium deposits which have grades substantially higher than the world average grade of about 0.1% U3O8. The Patterson Lake area has received escalating exploration attention and claim acquisition activity as a result of the new, near surface discoveries made by Fission which includes the recently reported drill interval of 38.49% U3O8 over 10.5 metres in drill hole PLS14-129. Consistent high-grade, near surface U3O8 assays from Fission demonstrate the potential for high-grade uranium mineralization on the geologically prospective yet underexplored margins of the western side of the Athabasca Basin.
Calyx (TSXV: CYX) Provides Corporate Update and Cancels Private Placement Financing
VANCOUVER, BRITISH COLUMBIA--(Marketwired - April 9, 2014) - Calyx Bio-Ventures Inc. (TSX VENTURE:CYX) ("Calyx" or the "Company") announces that it has entered into an agreement with BDC Capital Inc. and Agrisoma Biosciences Inc. ("Agrisoma") pursuant to which Calyx has agreed to waive its pre-emptive right in order to allow a third party to finance Agrisoma. The proposed Agrisoma financing, if it were to proceed as proposed and without Calyx's participation will, upon closing, dilute Calyx's interest in Agrisoma from 49.96% to approximately 29%. Following an evaluation by an Independent Committee of Calyx's board of directors, it was determined that in Calyx's view, Agrisoma's business had not progressed as expected, and no options for financing Agrisoma could be found that would be satisfactory to shareholders of Calyx.
Additionally, intellectual property ("IP") which was exclusively licensed to Agrisoma by Calyx is no longer under exclusive license to Agrisoma. With the IP reverting to Calyx, Calyx is now able to license and utilize its IP in other agricultural sector opportunities that it is currently investigating. The unique and powerful features of this technology provide clear advantages for the development of plant-based products. Calyx is in discussions and pursuing a number of new business opportunities in the agriculture and agri-pharmaceutical sectors including the MMPR (Marijuana for Medical Purposes Regulations) and marijuana biotech where we can bring our depth of agriculture capacities.
Accordingly, the Calyx board has determined to cancel the dilutive non-brokered private placement for the issuance of up to 35 million units at a price of six cents per unit for cash proceeds of up to $2.1-million previously announced on March 31, 2014.
About Calyx
Calyx Bio-Ventures Inc. (TSX VENTURE:CYX) is an agricultural technology company which is developing early stage agriculture ventures. Calyx brings its depth of experience, capital and other capacity, including its proprietary intellectual property, to enhance plant yields. In addition to Calyx's shareholding in Agrisoma Biosciences Inc., a company which is producing a non-food energy feedstock crop for bioenergy, Calyx is pursuing agri-pharmaceutical opportunities in the MMPR (Marijuana for Medical Purposes Regulations) and the agri-tech space. The medical marijuana industry is in its infancy and is an emerging multibillion-dollar opportunity undergoing significant regulatory and legal reform which offers strong growth opportunities to early participants. For further information about Calyx, please visit www.calyxbio.com
DLPM: Development Capital Group Names New Executives
MIAMI, FL--(Marketwired - April 08, 2014) - DEVELOPMENT CAPITAL GROUP, INC. (OTCQB: DLPM) ("the Company") is pleased to announce the appointment of two new Executives and Directors as outlined in the 8K filing of April 3, 2014. DLPM welcomes Shahbod "Shoubi" Rastegar as the new Chairman of the Board, CEO and Corporate Secretary; and Andrew Fleischer as a new Director, CFO and Company Treasurer. Johnathan Lindsay will step down as CEO and remain as a Director.
Shahbod Rastegar, 42, brings a strong background and network in online marketing to DLPM. He is the founder, Chief Executive Officer, and Chairman of Board of Clearance.co. From its inception on April 22, 2013, until present, he has run the day-to-day operations of Clearance.co and the development of strategic opportunities. Prior to Clearance.co, Mr. Rastegar was a co-founder of NextStepSocial, a social media agency focused on creating engagement, influence, awareness and action for corporate brands, products, celebrities, athletes and publications. Earlier in his career, Mr. Rastegar served as the president and co-founder of Metrix360, LLC and Pacific Media Project, both trusted Internet consulting agencies specializing in e-commerce marketing strategies.
In 1999, Mr. Rastegar was the VP and co-founder of TrafficMarketPlace, which is still one of the top 10 largest ad distribution networks in the world. TrafficMarketPlace, now renamed epicmarketplace.com, was sold to Vivendi/Universal in 2001. Mr. Rastegar began his Internet media career in 1998 at L90, Inc., a leading digital advertising network, as VP of sales. L90 executed a successful IPO on the NASDAQ exchange in 2000. Prior to L90, Mr. Rastegar served as Director of Sales at Servinet Consulting, a San Francisco based company specializing in providing custom network infrastructure, client/server software, Internet/Intranet development, and e-business integration.
Andrew Fleischer, 45, as CFO and Corporate Treasurer his primary duties involve overseeing the Company's financial reporting, fundraising, and advising on business strategy. Mr. Fleischer is the President of Strategic CFO Services, LLC, a Maryland-based business advisory professional services firm that provides CFO consulting services to technology firms, manufacturers and distributors, contractors, and other service businesses.
From 2008 to 2010, Mr. Fleischer was the Chief Financial Officer, North America, of GoIndustry-DoveBid PLC, a publicly-traded international e-Commerce leader in the online auction of used industrial assets. Mr. Fleischer played a key role in the integration of US-based DoveBid, Inc. into London-based GoIndustry PLC. From 2000 to 2008, Mr. Fleischer was the Chief Financial Officer of Alabanza Corporation and BulkRegister.com, Inc., industry leading Internet infrastructure companies. From 2004 to 2008, Mr. Fleischer was a Director and Treasurer of privately-held Alabanza Corporation. In 2006 and 2007, Mr. Fleischer led two successful divestiture transactions to sell BulkRegister and Alabanza to achieve shareholder objectives. From 1996 to 2000, Mr. Fleischer held financial and systems management positions with Honeywell that included implementing new financial systems and pricing service contracts. From 1990 to 1996, Mr. Fleischer held auditing and advisory roles with national and regional public accounting firms.
Mr. Fleischer is a licensed Certified Public Accountant (CPA) and received his Master's in Business Administration (MBA) from The Johns Hopkins University.
President, Joseph Ricard said of the recent appointments, "It is truly and honor to have the caliber of expertise that Mr. Rastegar and Mr. Fleischer bring to the Company. DLPM is building a management team that has a proven track record and we feel these are the ingredients for a successful future."
About Development Capital Group, Inc.
Development Capital Group, Inc. (OTCQB: DLPM) develops businesses and technologies with significant potential for growth and customer acquisition. The Company analyzes market trends and seeks opportunities to develop innovative technologies that capitalize on antiquated or under-serviced sectors. Our first internal application RealtyValuator.com is currently in private beta analyzing real-estate auction data for the State of Florida. For more information visit www.DevelopmentCapital.com.
About Clearance.co
Clearance.co is revolutionizing the shopping experience by bringing customers the finest quality, the best selection, the best service, and the lowest priced merchandise. Working directly with Manufacturers and Distributors, Clearance.co is the premiere online destination for close-out and clearance products and genuinely helpful customer service. Clearance.co is headquartered in Los Angeles, California. For more information visit www.clearance.co.
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Theralase (TSXV: TLT) Advances Anti-Cancer Technology Platform
(via Thenewswire.ca)
Toronto, Ontario / TNW-ACCESSWIRE / April 3, 2014 / Theralase Technologies Inc. ("Theralase") (TSXV: TLT) (TLTFF: OTCBB) announced today that it has advanced its anti-cancer technology platform through an executed research agreement with Acadia University ("Acadia"). Under the terms of the agreement, Acadia will supply initial quantities of Theralase's lead Photo Dynamic Compounds (PDCs) and the Standard Operating Procedures (SOPs) of how to synthesize them.
The lead PDCs will be used by Theralase to commence toxicity analysis and manufacturing ramp up via Contract Manufacturing Organization (CMO); both mandatory prerequisites in the evolution towards an approved Investigational New Drug (IND) application from the FDA and Health Canada. With larger quantities of the PDCs in hand and an approved IND; Theralase would be in the position to commence a Phase 1/2a human clinical trial for the lead indication of bladder cancer, as early as 1Q2015.
The lead PDCs have advanced towards international patent protection under a filed Patent Cooperation Treaty (PCT) application. Once approved at this phase, the Company plans to provide wide spread patent coverage of the PDCs across numerous countries during the national phase.
Dr. Sherri McFarland, Professor of Chemistry at Acadia University, the originator of the PDCs under worldwide exclusive licence to Theralase stated, "I am truly excited to work with Theralase in the development of these PDCs and be associated with their lead scientists and clinical oncologists to develop the next generation of anti-cancer technology. From the raw research I have observed, this technology has the potential to not only destroy one type of cancer, but many. I am convinced that this technology has the opportunity to go mainstream as a primary treatment in the destruction of cancer, within the next few years."
Dr. David MacKinnon, Dean, Research and Graduate Studies at Acadia University stated, "We are pleased to have partnered with Theralase in the development of these PDCs for the destruction of cancer. It is rewarding to advance research originally developed in our chemistry labs from conception through to commercialization knowing that it may one day be a cure for cancer."
Dr. Arkady Mandel, Chief Scientific Officer of Theralase stated that, "Sherri's strong background as a medicinal chemist and specialist in photochemistry, coupled with my scientific and medical knowledge as to how laser light interacts at the molecular and cellular level, will bring a new platform of cutting-edge anti-cancer technologies to the forefront within the next few years."
Roger Dumoulin-White, President and CEO of Theralase stated that, "I am delighted that Acadia has partnered with Theralase in the commercialization of technology that may provide a new front line treatment for cancer in the not too distant future. With good partners, disruptive technologies are born, which can make marked impacts on devastating diseases such as cancer, in our lifetime. I am humbled to be part of the process."
About Theralase Technologies Inc.
Theralase Technologies Inc. designs, manufactures and markets patented, superpulsed laser technology used in eliminating pain and destroying cancer. Theralase technology is safe and effective in eliminating pain, reducing inflammation and accelerating tissue regeneration of numerous nerve, muscle and joint injuries. Theralase is actively developing patented technology that is able to target and destroy cancers, bacteria and viruses when light activated.
Tekmira and Theralase Leaders in Innovative Drug Therapies
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Without aggressive research and regulatory approval, cancer could soon overtake heart disease as the leading cause of disease-related death in the United States. In Canada, cancer is already the number one killer, far and away outpacing heart disease. Small molecule drugs remain the standard of care, but the problem is that most are systemic and highly toxic or have dose-limiting qualities that minimize their efficacy and support the development of resistance. While the small molecule sector certainly still has upside, investors should be attentive to companies that are developing therapies with different mechanisms of action as the industry undergoes a dynamic shift towards accelerated approvals of innovative technologies.
The often-overlooked Canadian biotech space has grown into a $53-billion sector that offers a robust growth opportunity for investors. To that point, Tekmira Pharmaceuticals (TSX: TKM)(NASDAQ: TKMR) and Theralase Technologies (TSX-V: TLT)(OTCBB: TLTFF) are two dually-listed companies with large upside potential that have little competition to their pipelines, which are focused on RNA interference and photodynamic therapy, respectively.
RNA interference, or RNAi, was discovered essentially by accident just over a decade ago when Richard Jorgensen and colleagues found that by adding genes to petunias (in a bid to make them deeper purple), other native genes in the flower were silenced (turning the petunia white). This discovery of “switching off” genes via other cells has already led to promising research in viral conditions, such as hepatitis C and AIDS, and is taking root with new treatments for cancer on the horizon.
It’s discoveries like this and growing body of evidence for other treatments that makes the “Holy Grail” cure for cancer through new approaches, such as those of Tekmira and Theralase, even more attainable than ever before.
Tekmira has a pipeline of novel RNAi therapeutics as well as a lipid nanoparticle (LNP) drug delivery technology. The Burnaby, BC-based company has reached commercialization by licensing Marqibo, an FDA-approved liposomal formulation of vincristine for the treatment of certain acute lymphoblastic leukemia (ALL) patients, to Talon Therapeutics, which was subsequently acquired by Spectrum Pharmaceuticals (NASDAQ: SPPI) last July.
On its own or through partner Alnylam Pharmaceuticals (NASDAQ: ALNY), which uses Tekmira’s LNP technology in three trials, Tekmira has five drug candidates in the clinic, including Alnylam’s ALN-VSP for liver cancer and its own lead therapy TKM-PLK1 for solid tumors. PLK1 (short for polo-like kinase 1) is a protein known to be overexpressed is specific cancers. Tekmira hypothesizes – and data to date supports – that using the RNAi approach of TKM-PLK1 can inhibit the protein, disrupting tumor cell division and leading to apoptosis in the cancerous cells.
In August, Tekmira built upon encouraging data collected in a Phase 1 trial of TKM-PLK1 to initiate a Phase 1/2 trial enrolling patients with either advanced Gastrointestinal Neuroendocrine Tumors (GI-NET) or Adrenocortical Carcinoma (ACC). Interim data from this trial, which is scheduled to enroll about 20 patients, is expected in the second half of this year.
GI-NET carries a terrible prognosis, with one-quarter of those diagnosed with advanced neuroendocrine tumors dying within one year. With no FDA-approved drugs to treat, it is a prime candidate for accelerated pathways for development.
Tekmira also plans to soon initiate another Phase 1/2 trial of TKM-PLK1 for patients with primary liver cancer. This is a compelling part of Tekmira as it is strengthening its own cornerstones by sponsoring clinical trials focused on therapies, rather than being dependent on milestone and royalties payments centered on partners using its LNP technology.
Theralase Technologies is generating revenue already with its highly effective TLC-1000 system and building out additional products based on patented superpulse laser technologies for biostimulative and biodestructive clinical applications.
On the biostimulative front, the Toronto-based company sells its TLC-1000 cold laser system that can penetrate up to 4 inches of tissue to deliver subcutaneous light pulses that years of clinical research have proven to eliminate pain, reduce inflammation and promote cellular regeneration. In the simplest sense, the scaffolding of this technology is built upon the ability of cytochromes to absorb light energy and convert it to chemical energy to heal tissue without side effects.
The TLC-1000 system delivers efficacy in the range of 80% to 90% and Theralase is preparing to take that to the next level with the planned fourth-quarter launch of an enhanced version, dubbed TLC-2000. This system, according to Theralase CEO Roger Dumoulin-White, can increase efficacy up to 100% by using state-of-the-art technologies to define and deliver the precise amount and intensity of light energy necessary to treat patients on an individual basis. In the $100-billion pain management industry in the U.S. alone, for which traditional drug therapies and surgeries comprise only about $50 billion, Theralase could establish itself as a significant player in the business.
To date, Theralase has sold about 1,200 of the TLC-1000 systems (800 in Canada and 400 in the U.S.) that have successfully treated more than one million patients. Sales tallied $1.17 million through the first three quarters of 2013 and are projected to increase to about $6 million going forward as it launches the new product and transitions into an annuity-based model, as opposed to a one-time-sale model.
This steady revenue stream helps mitigate risk as Theralase moves strategically ahead with its true value proposition utilizing its expert photodynamic skill set to develop new treatments for cancer and bacterial infections.
Theralase has introduced a new method for selectively targeting cancer cells through the use of patented Photo Dynamic Compounds (PDCs), small molecules that are activated into tumor-killing form when exposed to very specific light sources. In order to provide the appropriate light energy, Theralase has custom designed the TLC-3000 medical laser system. In vitro and animal model studies, in part conducted at the world renowned Ontario Cancer Institute located at Princess Margaret Hospital, University Health Network, have demonstrated the unique potential and powerful results of the treatment across a broad array of cancer lines, including breast, brain, colon, pancreatic, prostate and bladder. In the research, low concentration doses have demonstrated up to 100% tumor destruction with no adverse side effects.
One particular mouse model study best exemplifies the potential of this novel therapy. In the study, about 350,000 cells from a bladder cancer line were injected into mice and tumors were allowed to grow to 5 millimeters in size. At that point, the mice underwent a single treatment of the PDCs and light therapy. In short, this process involves using a catheter to insert the PDCs into the bladder where they enter the cancer cell and lock onto the cell nucleus. The bladder is then drained and filled with distilled water to give it shape and a fiber optic bundle is inserted. The light activates the PDCs, which induces apoptosis, destroying the tumor from the inside out. The dead cells exit the body through urine. The single treatment eradicated 100% of the cancerous cells and had no side effects, according to the company. Follow-up 20 months after treatment showed the mouse models remained cancer-free, with no scar tissue. Considering 20 months is the life expectancy of a mouse, it seems fair to say that they were “cured” of cancer.
A one-treatment cure for cancer is almost unimaginable, yet this study showed it to be possible.
Of course, this is only one animal study and there is no guarantee that the robust efficacy will translate to humans, but it certainly offers hope and provides scientific evidence that is worthy of clinical trials. One of the best parts is that this Theralase process for bladder cancer takes less than three hours from start-to-finish, meaning that it holds the potential to be conducted on an outpatient basis should the therapy eventually garner regulatory approval.
Theralase is planning to commence clinical trials for bladder cancer in the first quarter of 2015. Bladder cancer is the fifth most common cancer in the U.S., with about 72,000 new diagnoses annually and 15,000 deaths attributed to the disease that carries a stark recurrence rate in the area of 80 percent. The indication represents an area of great unmet medical need, qualifying it for a potential FDA “Breakthrough Therapy” designation, a regulatory pathway passed into law in 2012 as a means to expedite development of innovative technologies for hard-to-treat diseases where patients have little to no options. Theralase has stated that this is a path that they intend to pursue should the Phase 1 clinical trial meet its endpoints.
Realistically, this only scratches the surface of Theralase. The company plans to expand its clinical pipeline by building on preclinical data targeting other localized cancer lines, such as breast and lung cancer. Further, a newly published scientific report showed that the company’s PDCs have been shown to destroy Staphylococcus aureus (s. aureus) and Methicillin Resistant Staphylococcus aureus (MRSA) in low oxygen atmospheres. This new discovery supports the intrinsic value of the Theralase platform technology, as cancerous and bacterial cells are aggressive and express strong drug resistance in hypoxic conditions.
Because Theralase is still preclinical with its cancer and bacterial therapies, the markets haven’t given any real valuation to these key components of Theralase’s business, holding the market capitalization around $25 million. It’s arguable that this valuation is low based solely upon Theralase’s commercialized product. Consider that generic drug giant Sun Pharma spent $230 million to acquire Dusa Pharmaceuticals in November 2008 to gain control of Dusa’s approved photodynamic treatment for a few skin conditions. The markets that Theralase is pursuing with its TLC-1000 and TLC-2000 are much larger. While the TLC biostimulative series is formidable and fair for comparatives, the real beauty of biotechs is the speculative nature of pipelines and the tremendous market opportunities that accompany novel therapeutics for large indications. It doesn’t get much bigger than the cancer and bacteria arenas and the markets have not yet baked-in this potential into Theralase’s valuation.
The life sciences equities on Bay and Wall Streets have been on fire for the past year, with U.S. biotechs essentially doubling in 2013, only to be topped by the 111% gain that Canadian stocks delivered. Both Tekmira and Theralase have been strong performers in the past four months and both have revenue streams to support further clinical research. It is companies like these that have assumed leadership positions with innovative approaches that are likely to continue to attract the attention of investors and other bigger pharmas in the future as they deliver this clinical data to validate their drug candidates.
Written by Robert James.
Highbank (HBK.V) Signs Tug & Barging Letter of Intent and Completes 'OLTC' Timber Assessment
VANCOUVER, BRITISH COLUMBIA--(Marketwired - March 27, 2014) - Highbank Resources Ltd. (TSX VENTURE:HBK)(FRANKFURT:V7O) (the "Company" or "Highbank") is pleased to announce:
TUG & BARGING LETTER OF INTENT ("LOI")
Highbank has signed a LOI with West Coast Tug & Barge Ltd.("West Coast Tug") of Campbell River, B.C. for barging aggregate from the Swamp Point North operation to destinations in the Port Simpson and Prince Rupert area. Highbank is pleased with the scheduling from West Coast Tug to provide two barges to operate from the property, which allows one to be loaded while the other is en route with aggregate to its destination or returning for re-loading.
It is anticipated that this LOI will be formalized soon and be in operation for the duration of all the construction projects in the northwest coast area. Victor N. Bryant comments, "With this agreement in place, Highbank is now able to deliver aggregate production at very competitive prices."
OCCUPANT LICENCE TO CUT ("OLTC")
Mr. Stan Spletzer, V.P. of Aggregate Operations, accompanied by a representative of Cypress Forest Consultants Ltd. of Terrace, B.C. helicoptered to the Swamp Point North site on March 24, 2014. A merchantable timber assessment was compiled and a report was delivered to Highbank. This assessment will be used to compile our OLTC application to the Ministry of Forests, Lands and Natural Resource Operations ("FLNRO").
Highbank is proceeding forward with providing the Ministry of Energy and Mines ("MEM"), with final engineered construction drawings, and further documents, as required within (30) days prior to mobilization to the site.
On behalf of the Board of Directors of
HIGHBANK RESOURCES LTD.
Victor N. Bryant, CEO/President
Theralase (TSXV: TLT) Developing Next Generation Medical Lasers
Toronto, Ontario / TNW-ACCESSWIRE / March 25, 2014 / Theralase Technologies Inc. (TSXV: TLT) (TLTFF: OTCBB) announced today the expansion of its engineering team to develop and commercialize its next generation of smart medical laser technologies. This highly trained engineering team will be instrumental in developing Theralase products to eliminate pain and heal tissue, a $100 Billion industry in the US and to destroy cancer, a $77 Billion industry in the US.
The first of these cutting-edge technologies under development is the patented TLC-2000, a technology that eliminates pain by automatically adjusting its laser parameters in direct relation to a patient's condition and their physical characteristics allowing the delivery of an optimized laser treatment, specific to a particular patient, each and every time. This dramatic advancement in pain medicine will allow much more effective patient specific treatments than currently available and also provide valuable treatment feedback information to the practitioner to further enhance the effectiveness of their patient's treatments. The second cutting-edge technology under development is the TLC-3000 anti-cancer medical laser, a patient specific cancer solution, which is able to deliver a specific dose of laser light through fibre optic bundles directly to cancerous tissues. The technology will be specifically designed to destroy tumours, wherever they may reside in the body, by activating patented Photo Dynamic Compounds (PDCs), already previously disclosed by the Company to be extremely effective in the destruction of cancer.
The newly expanded engineering team, managed by Wayne Embree, a senior engineering manager, who has been involved in leading engineering teams in the design and development of complex electronic technologies over the past 38 years. His team consists of 5 full time and 4 consultant engineering personnel, who are all resident experts in their respective fields of hardware, software, firmware and radio frequency communication design.
Mr. Embree, VP Engineering for Theralase, stated that, "I am excited to join Theralase and be associated with some of the leading minds in engineering, chemistry, biology, physics and medicine to develop the next generation of medical laser technology. The technology they have amassed to date is ground breaking and with its commercialization in the next few years, they will undoubtedly introduce to main stream medicine truly disruptive technology, which will have a dramatic effect on the way medicine is practiced for years to come."
Dr. Arkady Mandel, Chief Scientific Officer of Theralase stated that, "Wayne's strong engineering background coupled with my in-depth scientific and medical knowledge in how laser light interacts at the molecular, cellular and tissue levels in the human body, will bring a whole new platform of cutting-edge laser technologies to the forefront in the next few years."
Roger Dumoulin-White, President and CEO of Theralase stated that, "I am delighted that Wayne has joined the Theralase management team and am confident in his ability to commercialize the next generation medical laser technologies. His skill set will be an asset to the corporation as we launch these disruptive technologies, allowing the Company an ability to significantly increase its revenues."
About Theralase Technologies Inc.
Theralase Technologies Inc. designs, manufactures and markets patented, superpulsed laser technology used in eliminating pain and destroying cancer. Theralase technology is safe and effective in eliminating pain, reducing inflammation and accelerating tissue regeneration of numerous nerve, muscle and joint injuries. Theralase is actively developing patented technology that is able to target and destroy cancers, bacteria and viruses when light activated.
Additional information is available at www.theralase.com and www.sedar.com
Theralase (TSXV: TLT) Developing Next Generation Medical Lasers
Toronto, Ontario / TNW-ACCESSWIRE / March 25, 2014 / Theralase Technologies Inc. (TSXV: TLT) (TLTFF: OTCBB) announced today the expansion of its engineering team to develop and commercialize its next generation of smart medical laser technologies. This highly trained engineering team will be instrumental in developing Theralase products to eliminate pain and heal tissue, a $100 Billion industry in the US and to destroy cancer, a $77 Billion industry in the US.
The first of these cutting-edge technologies under development is the patented TLC-2000, a technology that eliminates pain by automatically adjusting its laser parameters in direct relation to a patient's condition and their physical characteristics allowing the delivery of an optimized laser treatment, specific to a particular patient, each and every time. This dramatic advancement in pain medicine will allow much more effective patient specific treatments than currently available and also provide valuable treatment feedback information to the practitioner to further enhance the effectiveness of their patient's treatments. The second cutting-edge technology under development is the TLC-3000 anti-cancer medical laser, a patient specific cancer solution, which is able to deliver a specific dose of laser light through fibre optic bundles directly to cancerous tissues. The technology will be specifically designed to destroy tumours, wherever they may reside in the body, by activating patented Photo Dynamic Compounds (PDCs), already previously disclosed by the Company to be extremely effective in the destruction of cancer.
The newly expanded engineering team, managed by Wayne Embree, a senior engineering manager, who has been involved in leading engineering teams in the design and development of complex electronic technologies over the past 38 years. His team consists of 5 full time and 4 consultant engineering personnel, who are all resident experts in their respective fields of hardware, software, firmware and radio frequency communication design.
Mr. Embree, VP Engineering for Theralase, stated that, "I am excited to join Theralase and be associated with some of the leading minds in engineering, chemistry, biology, physics and medicine to develop the next generation of medical laser technology. The technology they have amassed to date is ground breaking and with its commercialization in the next few years, they will undoubtedly introduce to main stream medicine truly disruptive technology, which will have a dramatic effect on the way medicine is practiced for years to come."
Dr. Arkady Mandel, Chief Scientific Officer of Theralase stated that, "Wayne's strong engineering background coupled with my in-depth scientific and medical knowledge in how laser light interacts at the molecular, cellular and tissue levels in the human body, will bring a whole new platform of cutting-edge laser technologies to the forefront in the next few years."
Roger Dumoulin-White, President and CEO of Theralase stated that, "I am delighted that Wayne has joined the Theralase management team and am confident in his ability to commercialize the next generation medical laser technologies. His skill set will be an asset to the corporation as we launch these disruptive technologies, allowing the Company an ability to significantly increase its revenues."
About Theralase Technologies Inc.
Theralase Technologies Inc. designs, manufactures and markets patented, superpulsed laser technology used in eliminating pain and destroying cancer. Theralase technology is safe and effective in eliminating pain, reducing inflammation and accelerating tissue regeneration of numerous nerve, muscle and joint injuries. Theralase is actively developing patented technology that is able to target and destroy cancers, bacteria and viruses when light activated.
Additional information is available at www.theralase.com and www.sedar.com
IntelGenx (IGXT) and RedHill Biopharma Receive Complete Response Letter From FDA for VersaFilm(TM) Oral Film Product for Acute Migraines
•FDA's letter accepted the bioequivalence study and safety information submitted and requires no additional clinical studies; IntelGenx and RedHill plan to address remaining issues, primarily related to third party manufacturing, packaging and labeling, within weeks based on available data
•In light of the increased regulatory clarity, IntelGenx and RedHill plan to rapidly advance ongoing discussions with potential partners for the commercialization of their Anti-Migraine "VersaFilm(TM)" Oral Film Product
•In addition to pursuing marketing approval in the U.S., IntelGenx and RedHill plan to complete the development program for the European market and submit a Marketing Authorization Application later this year
SAINT LAURENT, Quebec, Feb. 4, 2014 (GLOBE NEWSWIRE) -- IntelGenx Corp. (IGX.V) (IGXT) ("IntelGenx"), a Canadian drug delivery company focusing on oral drug delivery, and RedHill Biopharma Ltd. (RDHL) (RDHL) ("RedHill"), an Israeli biopharmaceutical company focused on the development and acquisition of late clinical-stage drugs, today announced that they received a Complete Response Letter ("CRL") from the U.S. Food and Drug Administration ("FDA") regarding the New Drug Application ("NDA") for their VersaFilm(TM) Oral Film Product for the treatment of acute migraines. The VersaFilm(TM) product is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.'s Maxalt(R).
A CRL is issued by the FDA's Center for Drug Evaluation and Research to inform companies that certain questions and deficiencies remain that preclude the approval of the application in its present form. The questions raised by the FDA in the CRL regarding the NDA for the anti-migraine VersaFilm(TM) product primarily relate to third party Chemistry, Manufacturing and Controls ("CMC") and to the packaging and labeling of the product. No questions or deficiencies were raised relating to the product's safety and the FDA's CRL does not require additional clinical studies.
While continuing to review the FDA's CRL, IntelGenx and RedHill believe that they can supply the requested information based on available data. IntelGenx and RedHill further believe that the majority of issues raised by the FDA were recently addressed in an amendment submitted by the companies to the FDA that has yet to be reviewed. The companies will work with the FDA to address the remaining questions in the CRL and plan to submit the requested information within a few weeks.
IntelGenx and RedHill have been in active discussions with potential partners for the commercialization of the product and expect to advance these discussions rapidly following FDA's CRL, which provides increased regulatory clarity, indicates that no further clinical trials are required, and raises no issues regarding to the product's safety.
"We appreciate the thorough review of the product NDA by the FDA. We remain committed to bringing the product to market as quickly as possible and will work closely with the FDA to advance the application and address all questions raised by the FDA," said Rajiv Khosla, IntelGenx' President and CEO and Dror Ben-Asher, RedHill's CEO in a joint statement. "We believe that the questions raised by the FDA can be addressed based on available data, and we plan to work vigorously to submit our response within a few weeks in order to bring this product to market as a new therapeutic option for the benefit of patients suffering from migraines."
In addition to pursuing marketing approval in the U.S., and following a positive meeting with the German pharmaceuticals regulation authority "BfArM" in October 2013, IntelGenx and RedHill plan to complete the development program for the European market and submit a Marketing Authorization Application for marketing approval of the product in Europe later this year, with Germany as the reference member state under the European Mutual Recognition Procedure.
About the VersaFilm(TM) Oral Film Product:
The product is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.'s Maxalt(R). Rizatriptan is considered one of the most effective oral triptans, a class of molecules that constrict blood vessels in the brain to relieve swelling and other migraine symptoms. The worldwide annual sales of triptans were estimated to have exceeded $1.6 billion in 20121, and the worldwide direct sales of Merck & Co.'s rizatriptan-based drugs exceeded $600 million in 20122.
The product is based on IntelGenx' proprietary "VersaFilm(TM)" technology. It dissolves rapidly in the mouth, leading to the absorption of the drug through the gastro intestinal track and into the bloodstream. The administration method of the oral thin film does not require the patient to swallow a pill or consume water, and presents a potentially attractive therapeutic alternative for many migraine patients, including those who suffer from migraine-related nausea - approximately 80% of the total migraine patient population3.
About IntelGenx:
IntelGenx is a drug delivery company focused on the development of oral controlled-release products as well as novel rapidly disintegrating delivery systems. IntelGenx uses its unique multiple layer delivery system to provide zero-order release of active drugs in the gastrointestinal tract. IntelGenx has also developed novel delivery technologies for the rapid delivery of pharmaceutically active substances in the oral cavity based on its experience with rapidly disintegrating films. IntelGenx' development pipeline includes products for the treatment of indications such as severe depression, hypertension, erectile dysfunction, migraine, insomnia, CNS indications, idiopathic pulmonary fibrosis, oncology and pain, as well as animal health products. More information is available about the company at www.intelgenx.com.