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Update leading in to the conference:
Enumeral Presents Research Results for Novel Class of Anti-PD-1 Antibodies at AACR’s 2016 Tumor Microenvironment Special Conference
Enumeral’s lead humanized anti-PD-1 antibodies demonstrated high levels of T-cell activation in ex vivo human immune cell assays and anti-tumor activity in in vivo studies
January 08, 2016 08:00 AM Eastern Standard Time
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Enumeral Biomedical Holdings, Inc. (OTCQB:ENUM) (“Enumeral” or the “Company”), a biotechnology company focused on discovering and developing novel antibody immunotherapies that help the immune system fight cancer and other diseases, today announced the presentation of research findings for the Company’s novel class of anti-PD-1 antibodies at the Function of the Tumor Microenvironment in Cancer Progression Conference, sponsored by the American Association for Cancer Research (AACR) and taking place in San Diego, CA, from January 7-10, 2016. Enumeral is advancing a novel class of potentially allosteric anti-PD-1 antibodies with distinctive properties compared to currently marketed anti-PD-1 antagonists, including a mechanism of action that does not appear to require the disruption of PD-1 interaction with PD-L1.
“Discovery and functional characterization of novel anti-PD-1 antibodies using ex vivo cell-based assays, single-cell immunoprofiling, and in vivo studies in humanized mice.”
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Enumeral is reporting in a poster presentation at the AACR conference that Enumeral’s anti-PD-1 antibodies can reverse T cell suppression in ex vivo assays by eliciting high levels of T-cell activation as measured by increased secretion of effector cytokines such as interferon gamma and increases in expression of the IL-2 receptor alpha chain, CD25. Further, in an in vivo preclinical model harboring a reconstituted human immune system, Enumeral’s fully humanized anti-PD-1 antibodies exhibited significant anti-tumor efficacy against a human lung adenocarcinoma xenograft.
In addition, Enumeral is presenting a second poster at the AACR conference detailing how Enumeral’s proprietary single-cell immune profiling technology was used to match T cell receptor alpha and beta (TCRa and TCRß) pair sequences from specified T cells isolated from the tumor of a metastatic melanoma patient and uniquely link them to their functional profiles. In this method, researchers first identified a subset of T cells of interest based on their functional profiles, including surface markers and secreted cytokines, and then isolated each individual T cell for TCR sequencing. Results presented demonstrated this method can be applied to T cells from both blood and solid tissues, enabling the identification of rare or expanded T cell clones.
Enumeral Abstracts at AACR’s 2016 Tumor Microenvironment Special Conference
“Determination of expressed T cell receptor sequences of single human T cells isolated after functional profiling.” Abstract #A14; Poster Session A: Tumor Immunity and Therapies; Thursday, January 7, 2016, from 7:30-9:30 PM Pacific Time.
“Discovery and functional characterization of novel anti-PD-1 antibodies using ex vivo cell-based assays, single-cell immunoprofiling, and in vivo studies in humanized mice.” Abstract #B30; Poster Session B; Friday, January 8, 2016, from 4:00-6:00 PM Pacific Time.
About Enumeral
Enumeral is a biopharmaceutical company discovering and developing novel antibody immunotherapies that help the immune system fight cancer and other diseases. The Company is building a pipeline focused on next-generation checkpoint modulators, with initial targets including PD-1, TIM-3, LAG-3, TIGIT, VISTA, and others. In developing these agents, Enumeral’s researchers apply a proprietary immune profiling technology platform that measures functioning of the human immune system at the level of individual cells, providing key insights for candidate selection and validation. For more information on Enumeral, please visit www.enumeral.com.
Forward Looking Statements Disclosure
This press release contains certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such statements reflect current beliefs of Enumeral Biomedical Holdings, Inc. (“Enumeral”) with respect to future events and involve known and unknown risks, uncertainties, and other factors affecting operations, market growth, Enumeral’s stock price, services, products and licenses. No assurances can be given regarding the achievement of future results, and although Enumeral believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, actual results may differ from the assumptions underlying the statements that have been made regarding anticipated events. Factors that may cause actual results, performance or achievements, or industry results to differ materially from those contemplated by such forward-looking statements include, among others, the risks that (a) Enumeral’s expectations regarding market acceptance of the Company’s business in general and the Company’s ability to penetrate the antibody discovery and development fields in particular, as well as the timing of such acceptance, (b) Enumeral’s ability to attract and retain management with experience in biotechnology and antibody discovery and similar emerging technologies, (c) the scope, validity and enforceability of Enumeral’s and third party intellectual property rights, (d) Enumeral’s ability to raise capital when needed and on acceptable terms and conditions, (e) Enumeral’s ability to comply with governmental regulation, (f) the intensity of competition, (g) changes in the political and regulatory environment and in business and fiscal conditions in the United States and overseas and (h) general economic conditions.
More detailed information about Enumeral and risk factors that may affect the realization of forward-looking statements, including forward-looking statements in this press release, is set forth in Enumeral’s filings with the Securities and Exchange Commission. Enumeral urges investors and security holders to read those documents free of charge at the Commission’s website at http://www.sec.gov. Forward-looking statements speak only as to the date they are made, and except for any obligation under the U.S. federal securities laws, Enumeral undertakes no obligation to publicly update any forward-looking statement as a result of new information, future events or otherwise.
Contacts
Burns McClellan, Inc., on behalf of Enumeral Biomedical Holdings
Investors
Steve Klass, 212-213-0006
sklass@burnsmc.com
or
Media
Justin Jackson, 212-213-0006, ext. 327
jjackson@burnsmc.com
http://www.businesswire.com/news/home/20160108005067/en/Enumeral-Presents-Research-Results-Class-Anti-PD-1-Antibodies
Leo Visited by Government Officials from Fushun, China
SEOUL, SOUTH KOREA / ACCESSWIRE / January 6, 2016 / Leo Motors Inc. (OTCQB: LEOM) hosted a meeting with Mr. Yingzhong Yuan, Vice Mayor of Fushun Municipal People's Government in the Liaoning Province of China. Four high ranking Fushun government officials accompanied the Vice Mayor. LEO's electric bus and truck manufacturing facilities are to be built in Fushun City.
This visit is meaningful because China has mandated beginning this year (2016) fifty percent (50%) of all new government vehicle purchases are to be electric powered in order to fight pollution and cut energy use. The mandate is facilitated by an exemption from sales tax.
LEO's electric cars and boats will be sold to government offices in three Northeastern Provinces of China (Liaoning, Jilin and Heilongjiang) encompassing Eastern Inner Mongolia.
LEO Executives and Chinese Government Officials
LEO demonstrated its proprietary electric vehicle technology for the visiting officials including a providing a demonstration ride on LEO's electric boat.
Leo has joint venture agreement with Fushun Jinyuan Technology Machinery Manufacturing Co., Ltd. ("JTY" or "Jinyuan") creating a Joint Venture Company ("JVC") in Fushun City in to develop, manufacture, and sell electric vehicles for Chinese and international markets.
In spite of the central government's mandate, there are very few electric vehicles in three Northeastern Provinces because of the extremely cold winters, at times dropping below -22 degrees F. In such cold temperatures traditional batteries do not function, making electric vehicles useless. LEO has solved the cold region problem with its recently invented electric vehicle battery power pack using Carbon Nano Tube (CNT) Technology that is fully functional and supplies full power in low temperatures (under -49 degrees F) without any capacity or power loss.
Dr. Kang, CEO of Leo Motors commented, "City government officers were satisfied with our technology. This visit will make our marketing to the Chinese government easier."
This press release includes "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements labeled with the terms "believes," "belief," "expects," "intends," "anticipates," "will," or "plans" to be uncertain and forward looking. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the company's reports and registration statements filed with the Securities and Exchange Commission.
For more information please call
Princeton Research, Inc
Mike King 702 650 3000
SOURCE: Leo Motors
https://www.accesswire.com/435351/Leo-Visited-by-Government-Officials-from-Fushun-China
Nice to see the action here I was pleased to add 2's this week on that news to the 2's I bought over a year ago lol
Always liked the outlook here, S/S,restructured debt with 0 convertibles and extremely responsible management This looks to be the year .10 could come very fast and sustain gains.
Chart has every indicator going positive nothing not to like here.
Very undervalued with market cap under a million I think we will see an uptrend here finally ...it is an extremely attractive stock that is clearly not going lower and tightly held.
I wonder if we'd seen 4's today if Form 4 had been done properly...it's coming
Thanks to all for pointing that blunder out today, I obviously thought it was a disposition and while that doesn't inspire buyers and even caused me to move on to others this morning, I would have been OK had that been the case and just figured good time to get that business done lol .. after all our CEO owns what is now 12 512 580 commons and I also checked the total on his last form 3.... today's 720 000 were an acquisition indeed.
Now I want more too then lol
Microphase Corp still has at least 8 666 666 shares locked up as well
http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=10167963
Low Locked Float I look forward to seeing continued volume and new buyers arrive in 2016
Happy New Year AMPG!
Wow this is big news Ms. Coffeenut thank you kindly for pointing it out. I missed this one I see now it was released on a Sunday evening ...much like LEOM it went under the radar.
Was a flash test I hope there is another, will be certain to set some GTC orders this week, I too want to add as much as I can this time of year presenting bargains galore.
More awareness will come rapidly 2016 after finishing 2015 with a notable running start!
http://www.ebdgroup.com/bts/presenters/prs_comps.php
Approx. 33% retrace from recent highs started a position as of last week
40900 ($45K) top bidder CSTI $1.10
3000 CANT also @ $1.10
100 Ask NITE $1.11
Premarket looks thin to the upside congrats to all holding I feel a fast move coming this morning
http://www.prnewswire.com/news-releases/sciclone-to-pursue-development-of-sgx942-in-china-following-soligenix-report-of-positive-phase-2-preliminary-results-in-oral-mucositis-300195617.html
SciClone To Pursue Development Of SGX942 In China Following Soligenix' Report Of Positive Phase 2 Preliminary Results In Oral Mucositis
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SciClone Pharmaceuticals, Inc. Logo.
SciClone Pharmaceuticals, Inc. Logo.
FOSTER CITY, Calif., Dec. 21, 2015 /PRNewswire/ -- SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced plans to pursue development and registration of SGX942 in the Greater China market, for the treatment of oral mucositis. SGX942 is being developed by Soligenix, Inc. (OTCQB: SNGX), which recently reported positive preliminary results from its Phase 2 clinical trial for the treatment of oral mucositis in head and neck cancer. SGX942 is an innate defense regulator (IDR), a new class of short, synthetic peptides, with a novel mechanism of action in that it modulates the body's reaction to both injury and infection towards an anti-inflammatory and an anti-infective response. The Phase 2 preliminary results reported by Soligenix showed a significant reduction in the duration of severe oral mucositis in patients receiving chemoradiation therapy for treatment of their head and neck cancer.
In April 2013, SciClone and Soligenix established a commercial collaboration in which Soligenix received access to SciClone's oral mucositis clinical and regulatory data library in exchange for commercialization rights to SGX942 in the People's Republic of China, including Hong Kong and Macau. The data library derived from SciClone's development of SCV-07 for the treatment of oral mucositis caused by chemoradiation therapy in head and neck cancer which targeted the same patient population Soligenix is pursuing in its oral mucositis program. SciClone discontinued development of SCV-07 in 2012.
Friedhelm Blobel, PhD, SciClone Chief Executive Officer, commented: "The positive results demonstrated in the Phase 2 study of SGX942 are compelling, representing promise for an intervention for patients with head and neck cancer treated with chemoradiation who are suffering with oral mucositis. Cancer is one of China's most pressing healthcare challenges. We have significant development, regulatory and commercial expertise in the China oncology market, and believe that SGX942 could be a valuable addition to our oncology portfolio in the future. Our plans are to develop SGX942 for the Greater China market, and to work with Soligenix to define both a business and development path forward toward that goal."
"We were very excited with the outcome of the Phase 2 clinical study of SGX942, as oral mucositis is a devastating side effect of chemoradiation and represents a significant unmet medical need and commercial opportunity worldwide," said Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Access to SciClone's data library was of significant value to Soligenix in designing our Phase 2 program. We are delighted that SciClone intends to pursue development of SGX942 in the China market, where they have a significant commercial presence, and look forward to our companies continuing to work in collaboration."
Specific terms of the collaboration between SciClone and Soligenix have not been disclosed at this time.
About SciClone
SciClone Pharmaceuticals is a revenue-generating, specialty pharmaceutical company with a substantial commercial business in China and a product portfolio spanning major therapeutic markets including oncology, infectious diseases and cardiovascular disorders. SciClone's proprietary lead product, ZADAXIN® (thymalfasin), is approved in over 30 countries and may be used for the treatment of hepatitis B (HBV), hepatitis C (HCV), and certain cancers, and as a vaccine adjuvant, according to the local regulatory approvals. The Company has successfully in-licensed and commercialized products with the potential to become future market leaders and to drive the Company's long-term growth, including DC Bead®, a novel treatment for liver cancer. Through its promotion business with pharmaceutical partners, SciClone also markets multiple branded products in China which are therapeutically differentiated. SciClone is a publicly-held corporation based in Foster City, California, and trades on the NASDAQ Global Select Market under the symbol SCLN. For additional information, please visit www.sciclone.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding the development of SGX942, the prospects for SGX942 in the Greater China market and other matters. Readers are urged to consider statements that include the words "may," "will," "would," "could," "should," "might," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "designed," "goal," "approximately" or the negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject to risks and uncertainties that are difficult to predict and actual outcomes may differ materially. These include risks and uncertainties relating to risks relating to the product development and clinical trial process, including uncertainties regarding the time and costs related thereto, and risks relating to performance by us and by Soligenix of obligations under the agreement with Soligenix, as well as well as risks and uncertainties relating to: the course, cost and outcome of regulatory matters, including regulatory approvals and future pricing decisions by authorities in China; the on-going regulatory investigations and expenses related thereto, including potential fines and/or other remedies. Please also refer to other risks and uncertainties described in SciClone's filings with the SEC. All forward-looking statements are based on information currently available to SciClone and SciClone assumes no obligation to update any such forward-looking statements.
SciClone, SciClone Pharmaceuticals, the SciClone Pharmaceuticals design, the SciClone logo and ZADAXIN are registered trademarks of SciClone Pharmaceuticals, Inc. in the United States and numerous other countries.
Corporate Contacts
Wilson W. Cheung
Jane Green
Chief Financial Officer
Investors/Media
650.358.3434
650.358.1447
wcheung@sciclone.com
jgreen@sciclone.com
Logo - http://photos.prnewswire.com/prnh/20150722/240358LOGO
SOURCE SciClone Pharmaceuticals, Inc.
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Agreed but 2 entirely different disorders
Yep BMAK is mostly antagonizing to assist bids to fill at this point certainly hasn't been selling much for several weeks now ... I see he gone done the disappearing act again took an early week end weeeeeee
Friday buy day? Bids loaded .. or flat?
Testing that 38 with AON ...nothing .. what's there?
Mexican Stand Off
Derek Brand, Vice President of Business Development for Enumeral named to Bioentrepreneur Program
http://www.innovateli.com/nyc-exec-named-to-bioentrepreneur-program/
More News from Dec 7, 2015
Ramping up revs for 2016 I am accumulating all dips this range won't be here much longer.
Leom Subsidiary LGM Launches Iot-Based Life Vest
SOUTH KOREA / ACCESSWIRE / December 7, 2015 / Leo Motors Inc. (OTCQB: LEOM) LGM, a wholly owned subsidiary of Leo Motors announced the global launch of their "Connected Life Vest", a life vest that utilizes Internet of Things (IoT) technology, Carbon Nano Tubes (CNT), and our proprietary electric shock prevention system. The new vest provides a 300% increase in user survivability.
Mr. Won, CEO of LGM, said "Current Life Vests in the market are inadequate to preserve life in frigid water. We developed the Connected Life Vest save life using smarter and safer technology. When the Connected Life Vest is activated, it keeps the user's body warm for up to 4 hours, and sends user data including location, biometric status, and personal information."
Performance and IoT
Once the user enters the water, sensors of the Connected Life Vest detects water temperature and immediately activates the heating system and sends an SOS. Generally survivors cannot last over an hour in water 50°F or colder. However Connected Life Vest's heating system maintains the user's body heat for over 4 hours, dramatically increasing survivability.
The Connected Life Vest links to smartphones and NFC chips, continually monitoring and transmitting user's heart rate and temperature. All monitored data, including user's location, biometric data and crises level is transmitted to rescue centers, facilitating immediate lifesaving action. The Connected Life Vest's shoulders include LED features particularly useful in locating survivors in darkness.
Competitive Pricing & Initial Markets
LGM's pricing is competitive with conventional life vests. LGM's initial marketing targets passenger ships, and naval forces, and merchant marine organizations replacing expired life vests.
About LGM
LGM specializes in research, design, and production of electric ships, electric shock prevention technology, and electromagnetic wave prevention technology. The South Korea Ministry of Maritime Affairs and Fisheries recently selected LGM to provide electric fishing boats.
LGM is the first electric shipping company utilizing their patented battery cartridge system. It is extremely difficult to charge electric boats directly. Replacing the battery in boats weighing over 2 tons is arduous and heavy equipment intensive. LGM's modular system splits batteries into smaller cartridges weighing less than 20kg allowing easy manual replacement without relying on a crane.
On November 27th, LGM entered the market with three electric boats including 1.2 tons, 1.8 tons, and 3 tons. LGM's electric boats which use 120 hp. motors producing over 20 knots of speed are deliver more power than their Internal Combustion Engine (ICE) counterparts.
Because LGM's electric boats do not include batteries when sold, they're more affordable than their general ICE counterparts and the battery rental fee is cheaper than tax-free oil. Starting on March, 2016, LGM will accept potential buyers for practical demonstrations of the electric boats.
This press release includes "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements labeled with the terms "believes," "belief," "expects," "intends," "anticipates," "will," or "plans" to be uncertain and forward looking. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the company's reports and registration statements filed with the Securities and Exchange Commission.
For more information please call
Mike King 702 650 3000
SOURCE: Leo Motors Inc.
Source: Accesswire (December 7, 2015 - 2:17 AM EST)
http://www.baystreet.ca/quotedata/news-article.aspx
News never shows up on Ihub here was another PR out November 23, 2015
Leo Motors to Supply Its "Battery Swap System" In Electric Go Karts
SEOUL, SOUTH KOREA / ACCESSWIRE / November 23, 2015 / Leo Motors Inc. (OTCQB: LEOM) entered into a Memorandum of Understanding ("MOU") with the BRUNEI DARUSSALAM BIMP-EAGA BUSINESS COUNCIL (BDBEBC) to set up a GLOBAL Electric Go Kart (EGK) joint venture.
Image: https://www.accesswire.com/uploads/leom%2011-23%201.jpg
EGK's initial indoor Go Kart track installations will be in Brunei and on Jeju Island in Korea. Go Kart is one of most popular motor sports in Brunei where the venture is building the world's largest indoor Go Kart track of approximately 4 acres.
Leo will supply newly developed Go Kart using its proprietary cartridge battery swap system. Instead of the standard sidelining of the Go Kart for recharging, Leo's Go Karts swap a depleted battery for a fully charged one within seconds. Batteries are pre-charged in the charging center, eliminating the need for players to wait for charging.
Dr. Kang, CEO of Leo Motors said, "Because our Go Karts use electric motors without suffocating fumes or deafening noise, they are perfect for indoor use." He added, "Using our patented cartridge battery system, we eliminate all problems related to battery charging. This will revolutionize the electric Go Kart industry,"
Leo Motors and BDBEBC are also working together to convert all water boat taxis into electric boat taxies in the world's largest water village in Brunei. The new electric water taxies will be connected through the cloud server and smart phones. The battery condition and taxi locations are continuously monitored by the cloud computer. The battery logistics are to be governed by artificial intelligence. And electric water taxies can be called and automatically paid in the same manner of Uber.
This press release includes "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements labeled with the terms "believes," "belief," "expects," "intends," "anticipates," "will," or "plans" to be uncertain and forward looking. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the company's reports and registration statements filed with the Securities and Exchange Commission.
http://www.baystreet.ca/quotedata/news-article.aspx
http://www.baystreet.ca/quotedata/news-article.aspx
November 30. 2015
Leo Motors Launches Line of Electric Vehicles & Boats Using "Swappable" Batteries
SEOUL, SOUTH KOREA / ACCESSWIRE / November 30, 2015 / Leo Motors Inc. (OTCQB: LEOM) LEO unveiled five new electric vehicles: an electric cargo one-seater car, a delivery truck, a garbage truck, and two electric fishing boats (1.15 ton, 80 hp. and 1.85 ton, 20 hp.) at a product launch event in Busan, Korea. Busan is the largest marine city in Korea.
Dr. Shi Chul Kang, CEO of Leo Motors said, "'Batteries Not Included,' is our motto. Our customers do not need to purchase expensive batteries when buying Leo electric cars and boats. Instead, they rent charged batteries from our Battery Swap Centers. Our battery rental program lowers the financial burden of buying an electric vehicle. By eliminating the battery cost, Leo's electric vehicles are less expensive than their Internal Combustion Engine (ICE) counterparts."
Image: https://www.accesswire.com/uploads/LEOM%2011-30%201.jpg
The new 100% electric LEOM vehicles include:
E-Dot, a 100% electric cargo one-seater with a cargo space of 7 cubic feet. Its maximum weight capacity is 220 pounds and the cargo space can be replaced with a second passenger seat.
LC-1, a light delivery truck with low decks and wide ramps for easy loading, and a maximum carrying capacity of 1,100 pounds, making it ideal for small deliveries. Its sister model LC-2 has an 1,100 pound capacity garbage collection container.
Conventional delivery or garbage trucks drive for an average of 18 hours daily. This is a concern in considering an electric truck because of charging time. However Leo's trucks utilize our patented battery replacement system therefore eliminating charging down-time. Leo's new vehicle lines do not include batteries. Instead their drivers simply rent charged batteries from Leo's innovative battery swap stations.
Batteries at Leo's battery swap stations are owned by the station operators and rented to the electric vehicle owners. This not only significantly reduces the price of the vehicle but also eliminates concerns about battery life span.
Battery swap is not a new concept. 'Better Place' and 'Tesla' were each unable to bring such concepts to fruition. The reality is that an owner of a costly car like Model S (Tesla) would not swap his expensive, new battery for something pre-owned. Batteries comprise the biggest portion of the price of electric vehicles and once a driver-owned battery swap is made, the resale value of the car changes dramatically.
Another challenge of prior battery swap methods is that such stations were s extremely expensive. Swapping a battery power pack weighing more than 1,000 lbs. is not an easy task and requires an extravagant facility. Leo's solution for this dilemma is our proprietary CB (Cartridge Battery) technology. Leo's CB splits the battery into smaller, lightweight cartridges that are designed for quick and easy handling.
When CB works in harmony with Leo's newly innovated Battery Swapping Machines, the time required is equivalent to fueling gas vehicles of equivalent size. Leo's battery swapping machines are carts which replace battery cartridges eliminating the need for expensive large robot arms to handle massive battery packs. Using this shopping cart sized device, a typical 20 cartridge replacement takes 5 minutes.
A bonus feature is that Leo's battery power packs are connected through a mobile network via the driver's smart phone. Once the driver gets into the car, his or her smart phone automatically syncs with Leo's OS. Using an IoT (Internet of Things) platform, the driver can monitor battery life, receive replacement alert service (automatically sent when the battery is running low) and information on nearest swap station. Leo's platform also provides cloud based electric power management data and condition of electric power train monitoring services as well as EV fleet management services, roadside emergency battery charging or swap services, and self-certification services of chargers. If battery life is insufficient to reach a swap center, it transmits the emergency battery swap truck to swap the battery at roadside.
Regarding the rental cost, Dr. Kang added, "The rental price of charged batteries will vary based on the local electricity rates and subsidies given to the electric vehicles. In Korea, the government subsidizes up to 50% of the costs for purchasing electric cars or boats. The rental price is estimated to be less than price of gas."
In the launching event, Leo also demonstrated its electric shock prevention and electromagnetic radiation prevention technologies. The growing demand for electric and hybrid electric vehicles is creating a proliferation of batteries in excess of 300 Volts. Users of such cars are exposed to the potential of fatal electric shock accidents. E-boat power systems have traditionally presented electric shock hazards because of the proximity of water. LEO's new technologies eliminate such dangers. This new technology makes LEOM to be the first company in the world offering water friendly electric cars and boats.
Some hybrid and electric cars may be carcinogenic based on emission of extremely low frequency, electromagnetic radiation (EMR), or magnetic fields. Existing EV's have attempted to block EMR using shields on battery power packs, controllers, and the motor. But they cannot prevent EMR from wires connecting major components of an EV. Sometimes enormous EMR (like micro wave oven) is emitted when accelerating the EV. Leo uses proprietary EMR elimination circuits in each power source, thus no EMR is detected in all driving modes of Leo vehicles.
This press release includes "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements labeled with the terms "believes," "belief," "expects," "intends," "anticipates," "will," or "plans" to be uncertain and forward looking. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the company's reports and registration statements filed with the Securities and Exchange Commission.
For more information please call
Princeton Research, Inc
Mike King 702 650 3000
SOURCE: Leo Motors
Source: Accesswire (November 30, 2015 - 1:22 PM EST)
News by QuoteMedia
www.quotemedia.com
BMAK moved to $8 ..wonder if he just read your post lol ...seems to be holding 4's pretty well last few sessions since BMAK doesn't rain all day here anymore imo opinion it was him selling his quota for the day just now @ .0045 .. Have my GTC bids in will take more 3's if other sellers get bored
Soligenix Announces Initiation of its Pivotal Phase 3 Clinical Trial of SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma
NORD and CLF working with Soligenix to Accelerate Enrollment
PRINCETON, N.J., Dec. 14, 2015 /PRNewswire/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that patient enrollment has been opened for its Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating SGX301 (synthetic hypericin), as a treatment for cutaneous T-cell lymphoma (CTCL). SGX301 has previously been granted both orphan drug and fast track designations from the US Food and Drug Administration (FDA) for the first-line treatment of CTCL, a rare disease and a class of non-Hodgkin's lymphoma, a type of cancer of the white blood cells that are an integral part of the immune system.
Soligenix has been working with leading CTCL centers, as well as with the National Organization for Rare Disorders (NORD) and the Cutaneous Lymphoma Foundation (CLF) to initiate this pivotal Phase 3 clinical trial with SGX301, referred to as the FLASH study (Fluorescent Light Activated Synthetic Hypericin), that will enroll 120 evaluable subjects.
SGX301 is a novel, first-in-class, photodynamic therapy that combines synthetic hypericin, a potent photosensitizer that is applied to the cancerous skin lesions and activated using a brief safe, fluorescent light treatment. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging chemotherapeutic drugs and other photodynamic therapies that are dependent on ultraviolet exposure. Topical hypericin has demonstrated safety in a Phase 1 clinical study in healthy volunteers. In a Phase 2, double-blind, placebo-controlled clinical study in CTCL patients, the drug was safe and well tolerated, with 58.3% of the CTCL patients responding to SGX301 treatment compared to only 8.3% receiving placebo (p ≤ 0.04).
"I enthusiastically support Soligenix in their efforts to improve outcomes for patients with CTCL, affecting up to 50,000 patients in the US," stated Alain Rook, MD, Director, Cutaneous Lymphoma Program, Hospital of the University of Pennsylvania. "I have been working closely with the Soligenix team on this Phase 3 clinical program and I am pleased it is now open to enroll patients. I believe that SGX301 has the potential to be a major step forward in the treatment of CTCL by providing a safer alternative therapy over the course of the patients' disease than is currently available."
"The initiation of the Phase 3 trial marks an important step in the development of SGX301 as a treatment for CTCL," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We are excited to be working with many experienced clinicians as well as with NORD and CLF, as we look to enroll in this pivotal study in an effort to address the significant unmet medical need in this orphan disease."
Based on the positive results demonstrated in the Phase 2 study of SGX301, the Phase 3 protocol will be a highly powered, double-blind, randomized, placebo-controlled, multicenter trial and will seek to enroll 120 evaluable subjects. The trial will consist of three treatment cycles, each of 8 weeks duration. Treatments will be administered twice weekly for the first 6 weeks and treatment response will be determined at the end of Week 8. In the first treatment cycle, approximately 80 subjects will receive SGX301 and 40 will receive placebo treatment of their index lesions. In the second cycle, all subjects will receive SGX301 treatment of their index lesions and in the third cycle all subjects will receive SGX301 treatment of all their lesions. Subjects will be followed for an additional 6 months after the completion of treatment. The primary efficacy endpoint will be assessed on the percent of patients in each of the two treatment groups (i.e., SGX301 and placebo) achieving a Partial or Complete Response (yes/no) of the treated lesions defined as a ≥ 50% reduction in the total Composite Assessment of Index Lesion Disease Severity (CAILS) score for 3 index lesions at the Cycle 1 evaluation visit (Week 8) compared to the total CAILS score at baseline. Other secondary measures will assess treatment response (including duration), degree of improvement, time to relapse and safety. The study is anticipated to complete enrollment with primary data available in the second half of 2016.
About Cutaneous T-Cell Lymphoma
Cutaneous T-cell lymphoma (CTCL) is a class of non-Hodgkin's lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system. Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin. These malignant cells migrate to the skin, causing various lesions to appear that may change shape as the disease progresses, typically beginning as a rash and eventually forming plaques and tumors. Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL.
CTCL constitutes a rare group of NHLs, occurring in about 4% of the approximate 500,000 individuals living with the disease. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects over 20,000 individuals in the US, with approximately 2,800 new cases seen annually.
About SGX301
SGX301 is a novel first-in-class photodynamic therapy utilizing safe visible light for activation. The active ingredient in SGX301 is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions and then activated by fluorescent light 16 to 24 hours later. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging chemotherapeutic drugs and other photodynamic therapies that are dependent on ultraviolet exposure. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p ≤ 0.04) improvement with topical hypericin treatment whereas the placebo was ineffective: 58.3% compared to 8.3%, respectively. SGX301 has received orphan drug and fast track designations from the US Food and Drug Administration (FDA), as well as orphan designation from the European Medicines Agency (EMA).
About Soligenix, Inc.
Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our BioTherapeutics business segment is developing SGX301 as a first-in-class photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201), and our novel innate defense regulator technology (SGX942) for the treatment of oral mucositis.
Our Vaccines/BioDefense business segment includes active development programs for RiVax™, our ricin toxin vaccine candidate, VeloThrax®, our anthrax vaccine candidate, OrbeShield™, our GI acute radiation syndrome therapeutic candidate and SGX943, our melioidosis therapeutic candidate. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. Currently, this business segment is supported with up to $57 million in government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).
For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.
This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment. Statements that are not historical facts, such as "anticipates," "estimates," "believes," "intends," "potential," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats conducting preclinical and clinical trials of vaccines, obtaining regulatory approvals and manufacturing vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.
SOURCE Soligenix, Inc.
RELATED LINKS
http://www.soligenix.com
http://www.prnewswire.com/news-releases/soligenix-announces-initiation-of-its-pivotal-phase-3-clinical-trial-of-sgx301-synthetic-hypericin-for-the-treatment-of-cutaneous-t-cell-lymphoma-300191886.html
Once the sell the news crowd are done penny plus coming
Looks thin & all retail
As much as I wish BMAK was in hiding this morning like he has been on and off this month, he actually plays pretty fair here with buying pressure he will uptick his ask ...or perhaps he doesn't have much of anything he certainly is no where near as aggressive as earlier in the year
TapImmune Presents New Data at San Antonio Breast Cancer Symposium Showing Robust Generation of T-Cell Immunity
JACKSONVILLE, Florida, December 10, 2015 /PRNewswire/ --
Vaccination with TPIV 100 boosts T-cell immunity to HER2 in HER2+ Breast Cancer Patients
Provides catalyst to start Phase II studies
TapImmune, Inc. (TPIV), a clinical-stage onco-immunology company specializing in the development of innovative peptide and gene-based immunotherapeutics and vaccines for the treatment of cancer & metastatic disease, today presented new data at the San Antonio Breast Cancer Symposium in the poster titled, "Robust generation of T-cell immunity to HER2 in HER2+ breast cancer patients with a degenerate subdominant HLA-DR epitope vaccine." The poster was co-authored by Dr. Wilson, Dr. Knutson, Dr Degnim and other researchers from the Mayo Clinic in Rochester, Minnesota and presented by Dr. Glynn Wilson of TapImmune and Dr. Amy Degnim MD of the Mayo Clinic.
Results showing that 90% of patients produce robust T-cell immunity suggest that TPIV 100 may be useful in several therapeutic applications including: prevention of disease recurrence when administered following standard-of-care treatment in women with no evidence of disease; administered as a combination therapy including in HER2 metastatic patients; and used before surgery to potentially induce tumor regression.
"These encouraging data provide the rationale and catalyst for TapImmune to start Phase II clinical trials on TPIV 100," stated Dr. Glynn Wilson, Chairman and CEO of TapImmune. "There is a clear and unmet need for more efficacious treatment in a larger population of HER2+ breast cancer patients and the data show TPIV 100 has the potential to address this need through several different therapeutic applications, pre, post and in conjunction with current standard of care treatments."
These data show the Phase I results on TPIV 100, a vaccine containing 4 Class II HER2neu antigens. In summary, vaccination generates T-cell immunity to naturally processed HER2neu antigens. Responses to the individual peptide antigens was high (ranging from 68-88%), which led to the majority (90%) of patients generating T-cells that recognized naturally processed antigens, a clear improvement over previous vaccines with more limited utility. Elevated T-cell frequency to HER2 was observed 3 months after the last vaccination demonstrating memory immunity. Antibody immunity to HER2 was modestly increased in vaccinated patients.
About TapImmune Inc.
TapImmune Inc. is an immunotherapy company specializing in the development of innovative technologies for the treatment of cancer, including metastasis, and infectious disease. The Company's peptide or nucleic acid-based immunotherapeutics, comprise one or multiple naturally processed epitopes (NPEs) designed to comprehensively stimulate a patients' killer T-cells, helper T-cells and to restore or further augment antigen presentation by using proprietary nucleic acid-based expression systems. The Company's technologies may be used as stand-alone medications or in combination with current treatment modalities. Please visit the Company's website at www.tapimmune.com for details.
Forward-Looking Statement Disclaimer
This release contains forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company's expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are "forward-looking statements". Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stored in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company's most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at www.sec.gov. The Company assumes no obligation to update the forward-looking statements.
CONTACTS:
TapImmune Inc.,
Glynn Wilson, Ph.D.
Chairman & CEO
+1-866-359-7541
SOURCE TapImmune Inc.
http://www.prnewswire.com/news-releases/tapimmune-presents-new-data-at-san-antonio-breast-cancer-symposium-showing-robust-generation-of-t-cell-immunity-561407061.html
Merger PR confirmation this morning
Wakey wakey boys and girls
Hydrophi Technologies Purchases Pro Star Freight Systems and Pro Star Truck Center 2014 Reported Revenues of New Subsidiaries in Excess of $27 Million
December 10, 2015 08:00 ET | Source: HydroPhi Technologies Group, Inc.
CHICAGO, Dec. 10, 2015 (GLOBE NEWSWIRE) -- Hydrophi Technologies Group, Inc., (OTC:HPTG) ( “Company”, “we,” “us,” or “our”) announced today that it completed the transaction to purchase, all of the outstanding stock of Pro Star Freight Systems Inc. and Pro Star Truck Center Inc. (collectively, “Pro Star”). The Pro Star purchase is an attempt to preserve and enhance shareholder value in light of ongoing challenges in the execution of the Company’s business mission to bring hydrogen on demand technology to older, mechanical injection vehicles. Hydrophi Technologies Group believes that the addition of the freight business well complements its technology business. “We are excited to bring our real world trucking experience to complement Hydrophi Technologies Group’s technology prowess,” stated Pro Star founder, Nikola Zaric.
Pro Star had unaudited management reported 2014 revenue of $27.3 million with net income of $660,000. Pro Star was purchased with a combination of cash, notes and preferred stock. For the complete terms of the transaction please see the Company’s most recent public filings.
Roger M. Slotkin, CEO and Chairman of HydroPhi Technologies Group, Inc., states when he visited Pro Star, he had the privilege of meeting and getting to know Mr. Zaric. “We believe the Pro Star business model, growth potential and significant expansion possibilities make this acquisition extremely prudent and should yield significant shareholder value.”
About Pro Star:
Pro Star is a Mid-Western based, long haul freight transportation company serving the continental United States. With dispatch operations in Bensenville, Illinois, Belgrade Serbia and Niš Serbia, and truck service centers in Indiana and Illinois, the company services and manages a fleet of around 150 trucks.
Forward-looking statements:
The above news release contains forward-looking statements. The statements contained in this document that are not statements of historical fact, including but not limited to, statements identified by the use of terms such as "anticipate," "appear," "believe," "could," "estimate," "expect," "hope," "indicate," "intend," "likely," "may," "might," "plan," "potential," "project," "seek," "should," "will," "would," and other variations or negative expressions of these terms, including statements related to expected market trends and the Company's performance, are all "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and involve a number of risks and uncertainties. These statements are based on assumptions that management believes are reasonable based on currently available information, and include statements regarding the intent, belief or current expectations of the Company and its management. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performances, and are subject to a wide range of external factors, uncertainties, business risks, and other risks identified in filings made by the company with the Securities and Exchange Commission. Actual results may differ materially from those indicated by such forward-looking statements. The Company expressly disclaims any obligation or undertaking to update or revise any forward-looking statement contained herein to reflect any change in the company's expectations with regard thereto or any change in events, conditions or circumstances upon which any statement is based except as required by applicable law and regulations.
http://globenewswire.ca/news-release/2015/12/10/794492/0/en/Hydrophi-Technologies-Purchases-Pro-Star-Freight-Systems-and-Pro-Star-Truck-Center-2014-Reported-Revenues-of-New-Subsidiaries-in-Excess-of-27-Million.html
Not to mention any Tom Dick or Harry can post their unsubstantiated claims on that site ... it should be called 'crybabywhiners.com'
Soligenix Receives $490,000 in Non-Dilutive Financing from New Jersey's Technology Business Tax Certificate Transfer Program
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PRINCETON, N.J., Dec. 9, 2015 /PRNewswire/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has recently received approximately $490,000, net of transaction costs, in non-dilutive financing via the state of New Jersey's Technology Business Tax Certificate Transfer Program (the Program).
This Program enables approved, unprofitable biotechnology businesses to sell their unused Net Operating Loss Carryovers (NOLs) and unused Research and Development (R&D) Tax Credits to unaffiliated, profitable corporate taxpayers in the state of New Jersey. This allows biotechnology businesses with NOLs to turn their tax losses and credits into cash proceeds to fund more R&D, buy equipment and/or facilities, or cover other allowable expenditures. The New Jersey Economic Development Authority (NJEDA) determines eligibility for the Program, the New Jersey Division of Taxation determines the value of the available tax benefits (NOLs and R&D Tax Credits), and the New Jersey Commission on Science and Technology evaluates the technology and its viability. The state of New Jersey was the originator of this Program and the first state to implement and fund it.
"As we are always looking for non-dilutive ways to fund our company, we are once again very pleased with NJEDA's decision to support advancing technology companies with the approval of our application in this year's program," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "This is our 6th year receiving NOL funding and it continues to be a welcomed and important addition to other significant non-dilutive funding we have been awarded from BARDA and NIAID. We are, again, very thankful for New Jersey's continued support of its biotechnology industry."
About Soligenix, Inc.
Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our BioTherapeutics business segment is developing SGX301 as a first-in-class photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201), and our novel innate defense regulator technology (SGX942) for the treatment of oral mucositis.
Our Vaccines/BioDefense business segment includes active development programs for RiVax™, our ricin toxin vaccine candidate, VeloThrax®, our anthrax vaccine candidate, OrbeShield™, our GI acute radiation syndrome therapeutic candidate and SGX943, our melioidosis therapeutic candidate. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. Currently, this business segment is supported with up to $57 million in government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).
For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.
This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment. Statements that are not historical facts, such as "anticipates," "estimates," "believes," "intends," "potential," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats conducting preclinical and clinical trials of vaccines, obtaining regulatory approvals and manufacturing vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.
SOURCE Soligenix, Inc.
http://www.prnewswire.com/news-releases/soligenix-receives-490000-in-non-dilutive-financing-from-new-jerseys-technology-business-tax-certificate-transfer-program-300190188.html
BMAK gone from the ask .. just like a couple weeks ago he wasn't active on the ask I think we see a breather at least
Not sure if it's just the rest of the day BMAK took off but here's to hoping it's the rest of the year!
BMAK has left the building we have 5 minutes to get to .0047 lol GO!
This should stem the tide of the downtrend .. L2 already moving up hopefully volume absorbs any warrants that may still be selling
I reiterate a fairly reliable clue and my personal buy trigger yesterday was WABR soaking up shares on top bid at the same time stayed parked @ $1.70 on the ask
News today states all on track
http://www.prnewswire.com/news-releases/soligenix-provides-clinical-program-updates-for-december-2015-300188068.html
Soligenix Provides Clinical Program Updates for December 2015
PRINCETON, N.J., Dec. 4, 2015 /PRNewswire/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today the following clinical program updates for December 2015:
The Phase 2 proof-of-concept clinical trial of SGX942 for the treatment of oral mucositis in head and neck cancer patients remains consistent with prior guidance. The Company anticipates that the study will be unblinded and preliminary results reported by December 18, 2015.
The Phase 3 pivotal clinical trial of SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL) remains consistent with prior guidance. The Company anticipates initiating and opening the study for enrollment by December 18, 2015.
About Oral Mucositis
Mucositis is the clinical term for damage done to the mucosa by anticancer therapies. It can occur in any mucosal region, but is most commonly associated with the mouth, followed by the small intestine. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of mucositis, that mucositis affects approximately 500,000 people in the US per year and occurs in 40% of patients receiving chemotherapy. Mucositis can be severely debilitating and can lead to infection, sepsis, the need for parenteral nutrition and narcotic analgesia. The gastrointestinal damage causes severe diarrhea. In oral mucositis the pain can be so intense as to limit the patient's ability to eat and even drink even with the use of opioid pain-killers. These symptoms can limit the doses and duration of cancer treatment, leading to sub-optimal treatment outcomes.
The mechanisms of oral and gastrointestinal mucositis have been extensively studied and have been recently linked to the interaction of chemotherapy and/or radiation therapy with the innate defense system. In oral mucositis, bacterial infection of the ulcerative lesions is now regarded as a secondary consequence of dysregulated local inflammation triggered by therapy-induced cell death, rather than as the primary cause of the lesions.
It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of oral mucositis, that oral mucositis in head and neck cancer is a subpopulation of approximately 90,000 patients in the US, with a comparable number in Europe. Oral mucositis almost always occurs in patients with head and neck cancer treated with chemoradiation therapy (>80% incidence of severe mucositis) and is common (40-100% incidence) in patients undergoing high dose chemotherapy and hematopoietic cell transplantation, where the incidence and severity of oral mucositis depends greatly on the nature of the conditioning regimen used for myeloablation.
Oral mucositis in head and neck cancer remains an area of unmet medical need where there are currently no approved drug therapies.
About SGX942
SGX942 is an innate defense regulator (IDR), a new class of short, synthetic peptides that has a novel mechanism of action in that it has simultaneous anti-inflammatory and anti-infective activity. IDRs have no direct antibiotic activity but modulate host responses, increasing survival after infections with a broad range of bacterial Gram-negative and Gram-positive pathogens, as well as accelerating resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy. SGX942 has demonstrated safety in a Phase 1 clinical study in healthy human volunteers and efficacy in numerous animal disease models including mucositis, colitis, skin infection and other bacterial infections. SGX942 and related analogs has a strong intellectual property position, including composition of matter. SGX942 was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada and approximately $40 million has been put towards its development to date, inclusive of government grants.
SGX942 has received fast track designation from the US Food and Drug Administration (FDA) for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in head and neck cancer patients. Fast track is a designation that the FDA reserves for a drug intended to treat a serious or life-threatening condition and one that demonstrates the potential to address an unmet medical need for the condition. Fast track designation is designed to facilitate the development and expedite the review of new drugs. For instance, should events warrant, Soligenix will be eligible to submit a new drug application (NDA) for SGX942 on a rolling basis, permitting the FDA to review sections of the NDA prior to receiving the complete submission. Additionally, NDAs for fast track development programs ordinarily will be eligible for priority review, which imparts an abbreviated review time of approximately six months.
About Cutaneous T-Cell Lymphoma
Cutaneous T-cell lymphoma (CTCL) is a class of non-Hodgkin's lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system. Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin. These skin-trafficking malignant T-cells migrate to the skin, causing various lesions to appear that may change shape as the disease progresses, typically beginning as a rash and eventually forming plaques and tumors. Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL.
CTCL constitutes a rare group of NHLs, occurring in about 4% of the approximate 500,000 individuals living with the disease. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects over 20,000 individuals in the US, with approximately 2,800 new cases seen annually.
About SGX301
SGX301 is a novel first-in-class photodynamic therapy utilizing safe visible light for activation. The active ingredient in SGX301 is synthetic hypericin, a potent photosensitizer which is topically applied to skin lesions and then activated by fluorescent light 16 to 24 hours later. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p = 0.04) improvement with topical hypericin treatment whereas the placebo was ineffective: 58.3% compared to 8.3%, respectively. SGX301 has received orphan drug designation from the FDA.
About Soligenix, Inc.
Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our BioTherapeutics business segment is developing SGX301 as a first-in-class photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201), and our novel innate defense regulator technology (SGX942) for the treatment of oral mucositis.
Our Vaccines/BioDefense business segment includes active development programs for RiVax™, our ricin toxin vaccine candidate, VeloThrax™, our anthrax vaccine candidate, OrbeShield™, our GI acute radiation syndrome therapeutic candidate and SGX943, our melioidosis therapeutic candidate. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax™. Currently, this business segment is supported with up to $57 million in government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).
For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.
This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment. Statements that are not historical facts, such as "anticipates," "estimates," "believes," "intends," "potential," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats conducting preclinical and clinical trials of vaccines, obtaining regulatory approvals and manufacturing vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.
If I remember right there is now 30 days grace to get the bid up to .01 with no reapplication or fees
But I am still not convinced that is the entire reason ..there are filings required regarding the merger as well imo
I agree and believe it will be over .01 easily and forever on the eventual PR ..my take is while the merger has happened, they will not PR until all the necessary subsequent filings are done and it officially closes.
If it dips more it is another Christmas gift it won't stay down
The timing of the QB status is too bad unless you are ready to buy more fear lol
I wonder if the merging entity is another reason on losing QB though ie: if they now have to be vetted and update officers, audits etc
Super happy with my holdings/average/freebies at this point but one eye every day all day on L2 here where's it going next??
I'm buying more either way ;)
$27M Revs = ASSETS + PROFITABLE IN YEAR 3 (Lots of front end costs first 3 years behind this company with exponential leverage for rapid growth)
$HPTG Down but far from out
$SNGX Thank you for the Christmas gifts today bought some 58's and more @ .60
Market Cap dropped $8M before noon ?? nice discount here imo
Seems to have settled down now but will be pleased to catch some more if sellers get irrational again lol
WABR just stepped up to top bid as I type another good indicator going up from here imo WABR very wise ;) follow the leader
Well said ..the volume is evident this stock has attracted every 1 min chart trader & their dog ...
They will be with us in and out flip flopping all over the place all the way up now ;)
difference being the flippers will buy lunch, accumulators will buy the restaurant!
Hydrophi EU getting a ton of volume today and up 28%
http://www.gpwinfostrefa.pl/GPWIS2/pl/emitents/quotations/TERRA,PLTERRA00016
Not sure how you didn't see ..I almost thought he was the ax here .. lots of references from others since May here is just one
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=117021766&txt2find=arca
perhaps warrants?
After smothering the ask for months ARCA is no where to be seen today & BKRT is parked @ $5 all day
$TPIV bring us a November to remember!
Nice news and shot in the arm here today PPCH to join the OTCQB Venture Index!
http://www.baystreet.ca/articles/news-article.aspx
News just hit the wires and gets better LOL
I guess nobody here was in the courtroom today LMAO
Emerging from bankruptcy!
http://www.businesswire.com/news/home/20151023005987/en/Homex-Announces-Successful-Recapitalization-Restructuring
New Business Plan Update filed today is the 'pump' Not gonna be dumping anytime soon WEEEEEEEEEEEE
Click on 'english' top right
Then under 'Investor Kit' click on 'Restructuring Plan'
http://www.homex.com.mx/ri/index.php
I am not so sure about that take a look at the same company's gains today on the Mexico Stock Exchange up 705%!
I can't find any news but I'd have to say the move is for real
http://www.reuters.com/finance/stocks/HOMEX.MX/key-developments
$PPCH Bullish and positive divergences on relatively low volume
http://stockcharts.com/h-sc/ui?s=PPCH&p=D&b=5&g=0&id=p61493630789
Great synopsis I love both and my port is very heavily weighted between TPIV and that R/S stock
First time I have been part of an R/S for the right reasons, the right time and that didn't tank the pps ... It appears to be a great strategy over there so far and Naz will certainly bring larger exposure for the very near catalysts
With $TPIV, one of the compelling reasons for me to invest and accumulate was the relatively recent R/S and lessened likelihood of that happening ... and I still doubt highly that will happen for this ticker but in all honesty I am far less afraid after what we are witnessing when the science is doing the talking and the prognosis is grand.