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VistaGen Therapeutics, Inc. (VSTA) Holds Key Position in Pharmaceutical Marketplace
VistaGen Therapeutics is center stage in one of the most important developments in recent history for the pharmaceutical industry. The California biotechnology company is set to use stem cell technology to transform the way new drug candidates are developed by allowing preclinical drug testing on actual human cells, which is believed to be far more clinically relevant than the current animal testing paradigm.
VistaGen’s revolutionary bioassay system can help pharmaceutical companies avoid spending years and millions of dollars developing and testing a new drug, only to find out in late-phase human tests that the drug is toxic to the heart and has to be discontinued. It’s one of the industry’s biggest fears, largely because it is such a common event. Approximately one third of potential new drugs fail in preclinical or clinical trials due to heart safety issues. It’s a major concern for the rest of us as well, since it significantly slows the development and approval of new drugs.
VistaGen uses advanced stem cell technology to grow specialized mature human cells which can then be used to create novel bioassay systems for superior predictive toxicology. Companies and researchers can learn early on if a drug needs to be modified to reduce heart safety hazards, saving huge amounts of time and money, and giving the drug a solid chance of making it to market. In addition, past candidates that have been shelved for heart toxicity concerns can now be cost effectively re-evaluated in the lab, allowing the development of safer variants.
VistaGen’s “human clinical trials in a test tube” technology gives the company many unique advantages in the marketplace:
• Proprietary differentiation of human pluripotent stem cells into mature cells
• Mature cells available for drug rescue, drug discovery, and cell therapy
• Drug rescue leverages prior investment on shelved drugs
• Opportunity to build a pipeline of drug rescue variants
• Numerous cell therapies, including heart, liver, and cartilage repair
VSTA Holds Key Position in Pharmaceutical Marketplace
VistaGen Therapeutics is center stage in one of the most important developments in recent history for the pharmaceutical industry. The California biotechnology company is set to use stem cell technology to transform the way new drug candidates are developed by allowing preclinical drug testing on actual human cells, which is believed to be far more clinically relevant than the current animal testing paradigm.
VistaGen’s revolutionary bioassay system can help pharmaceutical companies avoid spending years and millions of dollars developing and testing a new drug, only to find out in late-phase human tests that the drug is toxic to the heart and has to be discontinued. It’s one of the industry’s biggest fears, largely because it is such a common event. Approximately one third of potential new drugs fail in preclinical or clinical trials due to heart safety issues. It’s a major concern for the rest of us as well, since it significantly slows the development and approval of new drugs.
VistaGen uses advanced stem cell technology to grow specialized mature human cells which can then be used to create novel bioassay systems for superior predictive toxicology. Companies and researchers can learn early on if a drug needs to be modified to reduce heart safety hazards, saving huge amounts of time and money, and giving the drug a solid chance of making it to market. In addition, past candidates that have been shelved for heart toxicity concerns can now be cost effectively re-evaluated in the lab, allowing the development of safer variants.
VistaGen’s “human clinical trials in a test tube” technology gives the company many unique advantages in the marketplace:
• Proprietary differentiation of human pluripotent stem cells into mature cells
• Mature cells available for drug rescue, drug discovery, and cell therapy
• Drug rescue leverages prior investment on shelved drugs
• Opportunity to build a pipeline of drug rescue variants
• Numerous cell therapies, including heart, liver, and cartilage repair
Integrated Device Technology (IDTI) Launches Industry First with Integrated Timing, Thermal Management Solution
Integrated Device Technology Inc., a semiconductor solutions provider, today highlighted its roll-out of the industry’s first integrated timing, thermal sensor and fan control solution targeted at PC mobile platforms, digital video recorders (DVRs), set top boxes (STBs), Network Attached Storage (NAS) and enterprise Ethernet switches and routers.
The company said the technology reduces bill of materials (BOM) and application footprint, saving costs and increasing board space in densely populated enclosures.
“IDT’s new integrated timing and thermal management solution takes a system-level approach to bring value to the application,” Ram Iyer, vice president and general manager of the Computing and Multimedia Division stated in the press release. “We’ve leveraged our timing expertise and combined it with precision analog functions to simplify our customers’ designs, resulting in a space-saving, lower-cost solution that allows our customers to get to market sooner.”
The IDT 9TCS108x devices use a low-power system timing solution integrated with two-channel thermal sensor, and four-wire pulse width modulation (PWM) fan controller on a single chip. Because of its low-power PLL design, battery life is extended in portable applications. The multiple clock outputs of the device can replace on-board crystals to reduce physical size and weight.
The integrated thermal sensor features two channels designed to detect overheating conditions and improve system reliability with precise accuracy. A separate temperature alert function for each channel can be programmed to generate reference data for the fan controller or an alert signal for the system, providing design flexibility for different applications.
In addition, the fan controller allows for direct fan control without requiring a system interrupt or supplementary control circuitry, further simplifying the design. The new family of devices offer a number of output and frequency variants, and also provide additional thermal sensors and other control pins, which allows system designers to choose the device best suited to their application.
For more information visit www.IDT.com
China BCT Pharmacy, Inc. (CNBI) Announces Launch of 11 New Retail Pharmacy Stores in Guangxi
China BCT Pharmacy, Inc., a company that engages in pharmaceutical distribution, pharmacy retailing, and the manufacture of pharmaceuticals products in the People’s Republic of China, recently announced that the Company is currently in the final stages of launching eleven new retail pharmacy stores in Guangxi.
The new retail stores are primarily located in Liuzhou City and Liucheng County and are, on average, a size of 67 square meters. The company has estimated that the total upfront capital investment that is needed to complete site renovations for the new stores is approximately RMB 6.1 million ($1.0 million). Management anticipates that the 11 stores will come together to generate approximately RMB 8.8 million ($1.4 million) in annual sales once they have reached a level of maturity, with a payback period of about four and a half years. China BCT is currently in process of obtaining all of the necessary licenses for the businesses and will be completely operational by the end of this year.
“The launch of these 11 self-opened stores will further strengthen our footprint in Guangxi by bringing the total number of ‘Baicaotang’ branded stores to 219,” commented Mr. Hui Tian Tang, Chairman and Chief Executive Officer of China BCT Pharmacy Group, Inc. “These stores will offer a full range of pharmaceutical products supported by excellent customer service. We remain focused on continuing the vertical integration of our growing retail network and our wholesale distribution and manufacturing businesses to become the leading retail pharmacy in Guangxi,” Mr. Tang added.
For more information on China BCT Pharmacy Inc and its new retail pharmacy stores, visit their website at www.china-bct.com
Hydrogenics Corp. (HYGS) Awarded German Contract
Hydrogenics Corp. is a leading developer and manufacturer of hydrogen generation and fuel cell products. The company’s products are used in various applications, including electric cars, freestanding power plants, fueling stations, industrial processes and in wind and solar power systems.
The company today announced that it has been selected by the city of Herten, Germany (a center for renewable energy projects) to provide a wind-hydrogen energy storage solution. Wind energy is renewable source of power for communities looking to offset the demand traditionally served by power plants fueled by fossil fuels such as coal, oil and natural gas. It is also ideal for Germany, which is scheduled to phase out all nuclear power by 2020.
To meet the project requirements, Hydrogenics will provide one HySTAT 30 hydrogen generation unit and a HyPM 50 kilowatt fuel cell power system to Herten in 2012. This combination will demonstrate the distinct advantage of hydrogen energy storage with its ability to be highly scalable and capable of storing significant amounts of energy for long periods of time with negligible loss and zero carbon emissions.
From storage, the energy will be redeployed through fuel cells as electricity to the grid. Or as an alternative, it will be used to fuel zero emission vehicles and other devices such as industrial equipment.
For further insight into Hydrogenics and its technology, please visit the company’s website at www.hydrogenics.com
SMTC Corp. (SMTX) Announces Manufacturing Partnership with Prim’Tools
SMTC Corp. just announced the execution of a manufacturing partnership with Prim’Tools, one of the world’s most prominent manufacturers and distributors of laser level surveying equipment and measurement devices. Prim’Tools is part of Hexagon Group, a world leader in design, measurement, and visualization technologies and solutions.
SMTC’s Dongguan, China based manufacturing facility will provide Prim’Tools with a complete turn-key manufacturing solution for its next generation of laser precision measurement equipment. SMTC has assembled a dedicated core team for new product introduction (NPI) and performed design for manufacturing (DFM) analyses as part of its engineering solution based services. The company has also agreed to provide complex electronic manufacturing services, including Printed Circuit Board Assembly (PCBA) production, board level assembly and testing.
By leveraging SMTC’s expertise in Supply Chain Management (SCM) services, Prim’Tools gains a well-established network of material sourcing and purchasing power to help drive costs and reduce delivery times. Eric Lee, General Manager of Prim’Tools, stated, “We are confident that SMTC will be committed to providing Prim’Tools with excellent turn-key solutions and we very much look forward to building on this partnership as we move forward.”
“We’re delighted to welcome Prim’Tools as our newest customer,” commented Andy Li, Vice President and General Manager of SMTC China. “Our customers rely on our dedicated people and manufacturing capabilities as they deliver mission critical solutions to their end customers. We look forward to partnering with Prim’Tools to deliver superior service and operational excellence.”
Rocky Mountain Chocolate Factory (RMCF) Posts Sweet Q2, FY2012 Results
Rocky Mountain Chocolate Factory Inc., an international franchiser of gourmet chocolate and self-serve frozen yogurt stores and manufacturer of premium chocolates and other confectionery products, today reported its operating results for the second quarter and first half of fiscal year 2012.
For the second quarter of fiscal 2012, the company reported total revenues of $7.6 million, an increase of 14.3 percent compared to revenues of approximately $6.6 million in the second quarter of fiscal 2011.
Retail sales increased 58.7 percent to $1.4 million for the second quarter of 2012 compared to $923,000 in the comparable quarter of 2011. Same-store sales at company-owned stores increased 4.1 percent in the second quarter of 2012 compared with the second quarter of 2011.
Rocky Mountain Chocolate posted a 3.4 percent decline in net income for the second quarter of 2012 at $912,000, or $0.15 basic earnings per share, compared to $944,000, or $0.14 basic earnings per share, reported in the second quarter of FY2011. Diluted earnings per share decreased 6.7 percent to $0.14 in the second quarter of 2012 compared to $0.15 in the second quarter of 2011.
Bryan Merryman, chief operating officer of Rocky Mountain Chocolate, said the company opened four company-owned ALY stores in the first six months and has signed leases for five additional stores that will begin opening in November of this year. The company also opened two franchised ALY during the second quarter, with a third in September.
Merryman said the company anticipates maintained growth in the recently opened stores.
“Although none of the ALY stores has been open long enough for us to evaluate their full-year operating metrics, we have been pleased to date with the sales generated by the company-owned and franchised ALY stores,” Merryman stated in the press release. “We believe our entry into the frozen self-serve yogurt market has the potential to significantly enhance shareholder value in coming years, as this new initiative complements our chocolate store business, leverages our three decades of experience in franchising and provides diversification of our revenue base.”
The company also posted results for the first six months of fiscal 2012, reporting that total revenues increased 13.8 percent to approximately $16.2 million, compared with revenues of approximately $14.2 million in the first half of 2011. Retail sales increased 63.7 percent to $2.8 million in the first half of 2012 compared to $1.7 million in the first half of 2011. Same-store retail sales at company-owned stores increased 4.1 percent in the first half of 2012 when compared with the first half of 2011. Net income for the first half of fiscal 2012 declined 2.3 percent to $1.8 million, or $0.30 basic earnings per share, compared to $1.8 million, or $0.31 basic earnings per share, in the first half of 2011. Diluted earnings per share of $0.29 in the first half of 2012 were 3.3 percent lower than the $0.30 per share reported in the first half of 2011.
For more information visit www.rmcf.com
Rimage (RIMG) and Qumu Join Forces to Boost Presence in Video Communications Market
Rimage Corp., a leading provider of on-demand CD/DVD/Blu-ray Disc™ publishing systems, today announced that it has signed a definitive agreement to acquire enterprise video communications provider Qumu Inc.
Rimage will pay $52 million for the acquisition, which will provide Rimage with a solid presence in the video communications market as the company has established relationships with 100 Global 1000 customers. Notably, Qumu revenues have increased more than 45 percent per year over the past three years.
“Qumu is a cornerstone acquisition for Rimage and immediately positions us as a leader in the growing market for video communications and social enterprise applications for business,” Sherman Black, president and CEO of Rimage stated in the press release. “The Qumu acquisition accelerates Rimage’s strategy to distribute live, on-demand, downloaded and optical media content for a broad range of applications, on any mobile or desktop device. This acquisition significantly expands our market to new enterprise customers and offers opportunities for cross-selling to the installed base of customers of both Rimage and Qumu.”
Qumu sells its products through a direct sales force to banking, technology, telecom, universities and government agencies, among others. Revenues for 2010 totaled $10.3 million, and the company said it is on track to achieve approximately $15 million in 2011. Qumu is expected to generate approximately $21 million in revenue in 2012.
“As a result of the Qumu acquisition, Rimage is positioned to generate double digit top line growth in 2012. Overall, we anticipate cash from operations in 2012 to match the level of cash generated in 2011. Given our expected cash position post-acquisition and our confidence in generating overall growth in 2012, we believe a 70 percent dividend increase is warranted,” Black stated.
Qumu will be integrated into Rimage, enabling Rimage to offer its customers a suite of solutions for all content distribution applications across multiple platforms, including the desktop, smart phones and tablets.
“We are extremely excited to be joining forces with Rimage to more quickly extend Qumu’s unique video communications solution to a much larger market,” Ray Hood, president and CEO of Rimage stated. “We believe the combination of the two companies offers significant opportunities for growth in 2012 and beyond. Our optimism is demonstrated by the desire of our investors to take a portion of the purchase price in Rimage stock.”
Per the acquisition agreement, Hood will remain the leader of the Qumu team and will become senior vice president of Rimage.
For more information visit www.rimagecorp.com
Wave Systems Corp. (WAVX) Announces Global Expansion with Addition of IT Security Veteran Joseph Souren
Located in London, Wave has quickly earned a stellar reputation on Wall Street for reducing complexity, cost and uncertainty of data protection. Today, Wave announced the company plans to expand into Europe, the Middle East and Africa to capitalize on the growing demand for trusted computing security solutions that help organizations thwart the rise in cyber threat and comply with EU data protection regulations.
To lead this new wave of expansion, Wave has named security veteran Joseph Souren, MBS, Vice President and General Manager, EMEA to execute a sales strategy and build out the company’s channel program. Souren has led an illustrious career where he most recently served as VP of CA Technologies’ Internet Security Business Unit.
With an already strong customer-base in Europe through an array of customer relationships, EMEA will bring greater notoriety and acclaim to the young company. In reference to such expansion, Wave’s Executive Vice President of Marketing and Sales stated, “EMEA is a critical market for Wave and we’re committing greater resources and personnel to expand our customer base there. With yesterday’s security failing organizations at an alarming rate, it’s increasingly clear that organizations need a better approach — one rooted in hardware — to secure their networks and protect their data. Wave brings the knowledge and experience to provide businesses with the framework to establish a known computing environment.”
Commenting on why he joined the team at Wave, Mr. Souren stated, “I joined Wave for one reason — it has unrivaled expertise, knowledge and technology to uniquely address the crisis in global network security. Wave offers a framework for establishing greater security, ensuring that data thieves cannot steal the ‘crown jewels’ of the organization — its intellectual property. We are committed to retaining and expanding the current channel program, and adding local support resources. The VAR channel is especially important in EMEA.”
Currently, Wave Systems is trading in the $2.62 range. To learn more about the company as a whole, visit their corporate website at: www.wave.com
VistaGen Therapeutics, Inc. (VSTA) Potential Rewards Far Exceed Its Current Market Valuation
Over the past decade, the number of new drugs approved by the FDA has dropped by a full 50%, despite major increases in research and development by the pharmaceutical industry. It’s not unusual for a company to invest more than a billion dollars, and over a decade of skilled resources, to get a new drug candidate to market. The fact is that even the most promising candidates can be shelved late in the game, long after the money and time have been spent, due to toxicity issues that were not discovered earlier. It’s a huge loss to the developing company, but a greater loss to the people whose lives could have been improved or even saved.
This is not an isolated problem. It is estimated that approximately a third of all potential new drug candidates fail to meet safety requirements in preclinical or clinical trials. The result is a massive inventory of promising drugs that are currently discontinued due to safety concerns. However, with more predictive and clinically-relevant in vitro toxicology bioassay systems, many of these hibernating drug candidates could be revived and developed as variants which are as effective as the original, but without the safety concerns.
VistaGen Therapeutics, Inc. is a biotechnology company applying stem cell technology for drug rescue and cell therapy. Drug rescue combines human stem cell technology with modern medicinal chemistry to generate new chemical variants (“drug rescue variants”) of promising drug candidates that have been discontinued during preclinical development (“put on the shelf”) due to heart or liver safety concerns.
VistaGen’s versatile stem cell technology platform, Human Clinical Trials in a Test Tube, has been developed to provide clinically relevant indications, or predictions, of potential toxicity of new drug candidates before they are ever tested on humans. VistaGen’s human pluripotent stem cell-based bioassays more closely approximate human biology than conventional animal studies and nonclinical in vitro techniques and technologies currently used in drug development.
Using mature human heart cells produced from pluripotent stem cells, VistaGen leveraged its Human Clinical Trials in a Test Tube platform to develop CardioSafe 3D, a three-dimensional (3D) bioassay system for predicting the in vivo cardiac effects of new drug candidates before they are tested in humans. The Company now plans to leverage CardioSafe 3D to build a pipeline of new, safer, variants of once promising drug candidates that have been “put on the shelf” by pharmaceutical companies because of toxicity concerns, despite positive efficacy data signaling their potential therapeutic and commercial benefits.
VistaGen is also developing LiverSafe 3D, a predictive liver toxicity and drug metabolism bioassay system, and is preparing to initiate pilot preclinical development of cell therapy programs focused on autologous bone marrow transplantation and heart, liver and cartilage repair. Each of these development programs is based on the proprietary human pluripotent stem cell differentiation and cell production capabilities of the Company’s Human Clinical Trials in a Test Tube platform.
Since inception, VistaGen has obtained and employed more than $41 million from various strategic collaborations, investments and grant awards. Although investing in a small-cap company involves more risk, investors would be wise not to overlook the potential rewards as they far exceed the current market valuation of the Company (approximately $41 million market cap as of October 7, 2011). Revenues generated by just one drug successfully rescued and brought to market can total hundreds of millions, if not billions, of dollars within a couple years. Even more importantly, rescuing a drug candidate means the chance for rescued lives. Better cells make better medicine.
Cerner Corp. (CERN) Acquires Clairvia
Today, Cerner Corp. announced it has reached an agreement to acquire Clairvia, a health care workforce management solutions provider. Clairvia’s software applications and predictive models enable health care organizations to align staff and resources with patient needs in real-time, allowing caregivers to focus solely on patient care. The solutions advance patient care quality, safety and throughput, staff productivity and satisfaction, reimbursements and cost control.
The acquisition is anticipated to close in October 2011 and is not expected to have a material impact on Cerner’s 2011 financial results. Clairvia’s President and CEO, Beth Pickard, will join Cerner effective upon closure of the transaction.
Over 400 organizations across the globe currently use Clairvia’s solutions, ranging in size from large health care systems to specialty physician practices. These clients utilize a variety of electronic health record (EHR) systems, as Clairvia’s solutions are EHR-system agnostic and integrate with numerous platforms, including Cerner Millennium®. Clairvia’s Care Value Management suite will be integrated into Cerner’s broader cloud-based and interoperability platforms, Cerner Healthe Intent™ and CareAware®. This will allow Cerner to offer a comprehensive suite of resource management solutions.
“Health care worldwide is experiencing a resourcing deficit that is forecasted to grow dramatically in the next several years,” said Jeff Townsend, Cerner executive vice president and chief of staff. “The fundamental supply of staff and other assets simply cannot meet rising patient demand. Clairvia’s predictive models driven by EHR data not only cut costs by aligning the right resource at the right time but, more importantly, optimize patient outcomes. With this acquisition, we are solidifying our commitment to the workforce management marketplace and interoperable cloud-based solutions that focus on providing positive clinical, operational and financial returns for our clients.”
“EHRs document patient needs and expected courses of care while resource management systems store nurse competency, skills and availability data,” said Pickard, Clairvia president and chief executive officer. “We integrate those two databases in real time, at the point of care. Cerner’s resources and dedication to improving health opens the door for us to create additional solutions that enable health care organizations to accurately forecast demand and to proactively align staffing resources to meet that demand.”
The Ensign Group, Inc. (ENSG) Adds The Springs Skilled Nursing Facility to Growing Portfolio of Healthcare Operations
The Ensign Group, Inc., the parent company of the Ensign™ group of skilled nursing, rehabilitative care services, hospice care and assisted living companies, announced today that it has added The Springs to its growing portfolio of healthcare facilities. The Springs is a 59-bed Medicare only skilled nursing facility located in a prestigious section of San Diego County. As of October 1st when the asset acquisition became effective, the well-performing nursing facility had an occupancy rate of about 72 percent. The purchase was done with cash by an Ensign holding subsidiary.
The Springs at Pacific Regent La Jolla is one piece of a larger retirement community that not only includes the upscale senior independent living condominiums at the Pacific Regent Tower, but also includes an undeveloped one-acre parcel that could be used for a second 21-story residential tower.
“This is a strategic acquisition that adds to our growing portfolio in the important San Diego County market,” said Covey Christensen, President of Ensign’s Southern California-based Flagstone Group, a subsidiary of which will operate The Springs, in a press release on Thursday. “We are especially pleased to be joining La Jolla’s vibrant and well-regarded healthcare community,” he added.
This acquisition brings Ensign’s total outlets to 100 healthcare facilities, three hospice companies and three home health businesses in 10 states. Ensign management confirmed that the company is actively seeking additional opportunities to acquire both well-performing and struggling long-term care operations across the United States
More information about Ensign is available at www.ensigngroup.net
VistaGen Therapeutics, Inc. (VSTA) Announces Presentation of Human Stem Cell-Derived “Micro-Heart” Cardiotoxicity Assay at NIH Symposium
VistaGen Therapeutics, Inc., a biotechnology company applying stem cell technology for drug rescue and cell therapy, announced today a poster presentation of its research and development activities leading to validation of its human stem cell-derived “Micro-Heart” cardiotoxicity bioassay system, CardioSafe 3D™, at the fourth Symposium on Cardiovascular Regenerative Medicine hosted by the National Institutes of Health’s (“NIH”) National Heart, Lung and Blood Institute. The poster was presented by Dr. Ralph Snodgrass, VistaGen’s President and Chief Scientific Officer, at the NIH symposium held in Bethesda, Maryland on October 4 – 5, 2011.
The research and development work presented by Dr. Snodgrass underscores the advances VistaGen’s versatile pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube™, is driving in the areas of predictive toxicology and drug safety screening. Screening methods currently employed by the pharmaceutical industry to measure the potential toxicity of drug candidates do not accurately predict the cardiac effects of many new drug candidates. There is a growing recognition in the field that existing methods suffer from the use of either animal models, which respond differently than humans to many drugs, or cell lines that are engineered, transformed, non-human and/or of non-cardiac lineage and are typically focused on the effects of the drug candidate on a single cardiac ion channel. These methods yield both false positive and false negative results leading to important implications for patient safety and costly project terminations during clinical development. Human pluripotent stem cells have the potential to address these limitations by permitting the generation of functional human cardiac cells that express ion channels and auxiliary proteins relevant to the accurate measurement of cardiac function and evaluation of the possibility of long-term cardiac abnormalities.
“Cardiotoxicity has been implicated in almost 30% of drug withdrawals in the United States over the last 30 years,” said Dr. Ralph Snodgrass, President and Chief Scientific Officer of VistaGen. “Our human stem cell-derived ‘Micro-Heart’ cardiotoxicity assay, CardioSafe 3D™, will contribute to the efficient and rapid identification of safer drugs before valuable resources are lost developing drug candidates with toxicity issues that are undetected until human clinical trials are in progress or even after FDA approval resulting in withdrawal from the market.”
The poster describes work conducted by VistaGen’s scientists in collaboration with scientists at ChanTest Corporation in Cleveland, Capsant Neurotechnologies in Southampton (in the UK), and the laboratory of Dr. Gordon Keller at the University Health Network’s McEwen Centre for Regenerative Medicine in Toronto. The research described combines optimized stem cell cardiac differentiation protocols, a novel 3-dimensional culture system, and traditional electrophysiological measurements to assess drug-related safety data. The system, called a “Micro-Heart” Cardiotoxicity Assay, was validated by measuring the dose-dependent effects on cardiomyocyte cell viability and electrophysiological responses, as measured by patch clamp and field potential assays, of twelve compounds with known cardiac cytotoxicity or electrophysiology effects.
These drugs included Class III antiarrhythmic compounds, mixed ion channel compounds, antihistamines, sodium and calcium channel blockers, as well as antineoplastic agents. The observed action potential Vmax values of these highly enriched cardiomyocytes was approximately 3-6x higher than values reported in the literature, suggesting a more normal high-level sodium channel density in these cardiomocytes. Expected dose-dependent effects of typical hERG channel blockers on QT interval were observed, as well as dose-dependent effects of mixed ion channel drugs. In addition, direct dose-dependent drug cytotoxicity could also be measured.
The data described in the poster presentation have demonstrated that VistaGen’s human stem cell-derived “Micro-Heart” cardiotoxicity bioassay system is highly reproducible with very strong concordance with the in vivo cardiac effects of multiple classes of compounds. This work further supports VistaGen’s Human Clinical Trials in a Test Tube™ platform by demonstrating its strong applicability for preclinical cardiac safety screening, with greater sensitivity and predictive power than conventional animal models for compounds known to induce lethal arrhythmias. VistaGen is developing this platform for proprietary applications in drug rescue screening, cell therapy and regenerative medicine, and the validation of its stem cell-derived human cardiac cell-based assays represents another major step forward in demonstrating the clinical relevance and power of the platform.
To view the complete abstract of the presented poster, please visit the investors section of the VistaGen website at www.vistagen.com.
VistaGen is a recipient of the “Novel Reprogrammed Cells for Differentiation into Cardiomyocytes” grant funded by The National Heart, Lung, and Blood Institute (“NHLBI”). The goal of this grant is to explore novel approaches of creating patient-specific iPS cells. NHLBI’s Symposium on Cardiovascular Regenerative Medicine brings together experts in stem cell biology and clinical cardiovascular medicine to discuss research progress in the field. Through a discussion of emerging science in the field and its clinical applications, the symposium’s goal is to foster the translation of stem cell biology and research into human clinical applications. The Institute is part of the National Institutes of Health of the US Department of Health and Human Services.
VistaGen Therapeutics, Inc. (VSTA) Announces Presentation of Human Stem Cell-Derived “Micro-Heart” Cardiotoxicity Assay at NIH Symposium
VistaGen Therapeutics, Inc., a biotechnology company applying stem cell technology for drug rescue and cell therapy, announced today a poster presentation of its research and development activities leading to validation of its human stem cell-derived “Micro-Heart” cardiotoxicity bioassay system, CardioSafe 3D™, at the fourth Symposium on Cardiovascular Regenerative Medicine hosted by the National Institutes of Health’s (“NIH”) National Heart, Lung and Blood Institute. The poster was presented by Dr. Ralph Snodgrass, VistaGen’s President and Chief Scientific Officer, at the NIH symposium held in Bethesda, Maryland on October 4 – 5, 2011.
The research and development work presented by Dr. Snodgrass underscores the advances VistaGen’s versatile pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube™, is driving in the areas of predictive toxicology and drug safety screening. Screening methods currently employed by the pharmaceutical industry to measure the potential toxicity of drug candidates do not accurately predict the cardiac effects of many new drug candidates. There is a growing recognition in the field that existing methods suffer from the use of either animal models, which respond differently than humans to many drugs, or cell lines that are engineered, transformed, non-human and/or of non-cardiac lineage and are typically focused on the effects of the drug candidate on a single cardiac ion channel. These methods yield both false positive and false negative results leading to important implications for patient safety and costly project terminations during clinical development. Human pluripotent stem cells have the potential to address these limitations by permitting the generation of functional human cardiac cells that express ion channels and auxiliary proteins relevant to the accurate measurement of cardiac function and evaluation of the possibility of long-term cardiac abnormalities.
“Cardiotoxicity has been implicated in almost 30% of drug withdrawals in the United States over the last 30 years,” said Dr. Ralph Snodgrass, President and Chief Scientific Officer of VistaGen. “Our human stem cell-derived ‘Micro-Heart’ cardiotoxicity assay, CardioSafe 3D™, will contribute to the efficient and rapid identification of safer drugs before valuable resources are lost developing drug candidates with toxicity issues that are undetected until human clinical trials are in progress or even after FDA approval resulting in withdrawal from the market.”
The poster describes work conducted by VistaGen’s scientists in collaboration with scientists at ChanTest Corporation in Cleveland, Capsant Neurotechnologies in Southampton (in the UK), and the laboratory of Dr. Gordon Keller at the University Health Network’s McEwen Centre for Regenerative Medicine in Toronto. The research described combines optimized stem cell cardiac differentiation protocols, a novel 3-dimensional culture system, and traditional electrophysiological measurements to assess drug-related safety data. The system, called a “Micro-Heart” Cardiotoxicity Assay, was validated by measuring the dose-dependent effects on cardiomyocyte cell viability and electrophysiological responses, as measured by patch clamp and field potential assays, of twelve compounds with known cardiac cytotoxicity or electrophysiology effects.
These drugs included Class III antiarrhythmic compounds, mixed ion channel compounds, antihistamines, sodium and calcium channel blockers, as well as antineoplastic agents. The observed action potential Vmax values of these highly enriched cardiomyocytes was approximately 3-6x higher than values reported in the literature, suggesting a more normal high-level sodium channel density in these cardiomocytes. Expected dose-dependent effects of typical hERG channel blockers on QT interval were observed, as well as dose-dependent effects of mixed ion channel drugs. In addition, direct dose-dependent drug cytotoxicity could also be measured.
The data described in the poster presentation have demonstrated that VistaGen’s human stem cell-derived “Micro-Heart” cardiotoxicity bioassay system is highly reproducible with very strong concordance with the in vivo cardiac effects of multiple classes of compounds. This work further supports VistaGen’s Human Clinical Trials in a Test Tube™ platform by demonstrating its strong applicability for preclinical cardiac safety screening, with greater sensitivity and predictive power than conventional animal models for compounds known to induce lethal arrhythmias. VistaGen is developing this platform for proprietary applications in drug rescue screening, cell therapy and regenerative medicine, and the validation of its stem cell-derived human cardiac cell-based assays represents another major step forward in demonstrating the clinical relevance and power of the platform.
To view the complete abstract of the presented poster, please visit the investors section of the VistaGen website at www.vistagen.com.
VistaGen is a recipient of the “Novel Reprogrammed Cells for Differentiation into Cardiomyocytes” grant funded by The National Heart, Lung, and Blood Institute (“NHLBI”). The goal of this grant is to explore novel approaches of creating patient-specific iPS cells. NHLBI’s Symposium on Cardiovascular Regenerative Medicine brings together experts in stem cell biology and clinical cardiovascular medicine to discuss research progress in the field. Through a discussion of emerging science in the field and its clinical applications, the symposium’s goal is to foster the translation of stem cell biology and research into human clinical applications. The Institute is part of the National Institutes of Health of the US Department of Health and Human Services.
VSTA Announces Presentation of Human Stem Cell-Derived “Micro-Heart” Cardiotoxicity Assay at NIH Symposium
VistaGen Therapeutics, Inc., a biotechnology company applying stem cell technology for drug rescue and cell therapy, announced today a poster presentation of its research and development activities leading to validation of its human stem cell-derived “Micro-Heart” cardiotoxicity bioassay system, CardioSafe 3D™, at the fourth Symposium on Cardiovascular Regenerative Medicine hosted by the National Institutes of Health’s (“NIH”) National Heart, Lung and Blood Institute. The poster was presented by Dr. Ralph Snodgrass, VistaGen’s President and Chief Scientific Officer, at the NIH symposium held in Bethesda, Maryland on October 4 – 5, 2011.
The research and development work presented by Dr. Snodgrass underscores the advances VistaGen’s versatile pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube™, is driving in the areas of predictive toxicology and drug safety screening. Screening methods currently employed by the pharmaceutical industry to measure the potential toxicity of drug candidates do not accurately predict the cardiac effects of many new drug candidates. There is a growing recognition in the field that existing methods suffer from the use of either animal models, which respond differently than humans to many drugs, or cell lines that are engineered, transformed, non-human and/or of non-cardiac lineage and are typically focused on the effects of the drug candidate on a single cardiac ion channel. These methods yield both false positive and false negative results leading to important implications for patient safety and costly project terminations during clinical development. Human pluripotent stem cells have the potential to address these limitations by permitting the generation of functional human cardiac cells that express ion channels and auxiliary proteins relevant to the accurate measurement of cardiac function and evaluation of the possibility of long-term cardiac abnormalities.
“Cardiotoxicity has been implicated in almost 30% of drug withdrawals in the United States over the last 30 years,” said Dr. Ralph Snodgrass, President and Chief Scientific Officer of VistaGen. “Our human stem cell-derived ‘Micro-Heart’ cardiotoxicity assay, CardioSafe 3D™, will contribute to the efficient and rapid identification of safer drugs before valuable resources are lost developing drug candidates with toxicity issues that are undetected until human clinical trials are in progress or even after FDA approval resulting in withdrawal from the market.”
The poster describes work conducted by VistaGen’s scientists in collaboration with scientists at ChanTest Corporation in Cleveland, Capsant Neurotechnologies in Southampton (in the UK), and the laboratory of Dr. Gordon Keller at the University Health Network’s McEwen Centre for Regenerative Medicine in Toronto. The research described combines optimized stem cell cardiac differentiation protocols, a novel 3-dimensional culture system, and traditional electrophysiological measurements to assess drug-related safety data. The system, called a “Micro-Heart” Cardiotoxicity Assay, was validated by measuring the dose-dependent effects on cardiomyocyte cell viability and electrophysiological responses, as measured by patch clamp and field potential assays, of twelve compounds with known cardiac cytotoxicity or electrophysiology effects.
These drugs included Class III antiarrhythmic compounds, mixed ion channel compounds, antihistamines, sodium and calcium channel blockers, as well as antineoplastic agents. The observed action potential Vmax values of these highly enriched cardiomyocytes was approximately 3-6x higher than values reported in the literature, suggesting a more normal high-level sodium channel density in these cardiomocytes. Expected dose-dependent effects of typical hERG channel blockers on QT interval were observed, as well as dose-dependent effects of mixed ion channel drugs. In addition, direct dose-dependent drug cytotoxicity could also be measured.
The data described in the poster presentation have demonstrated that VistaGen’s human stem cell-derived “Micro-Heart” cardiotoxicity bioassay system is highly reproducible with very strong concordance with the in vivo cardiac effects of multiple classes of compounds. This work further supports VistaGen’s Human Clinical Trials in a Test Tube™ platform by demonstrating its strong applicability for preclinical cardiac safety screening, with greater sensitivity and predictive power than conventional animal models for compounds known to induce lethal arrhythmias. VistaGen is developing this platform for proprietary applications in drug rescue screening, cell therapy and regenerative medicine, and the validation of its stem cell-derived human cardiac cell-based assays represents another major step forward in demonstrating the clinical relevance and power of the platform.
To view the complete abstract of the presented poster, please visit the investors section of the VistaGen website at www.vistagen.com.
VistaGen is a recipient of the “Novel Reprogrammed Cells for Differentiation into Cardiomyocytes” grant funded by The National Heart, Lung, and Blood Institute (“NHLBI”). The goal of this grant is to explore novel approaches of creating patient-specific iPS cells. NHLBI’s Symposium on Cardiovascular Regenerative Medicine brings together experts in stem cell biology and clinical cardiovascular medicine to discuss research progress in the field. Through a discussion of emerging science in the field and its clinical applications, the symposium’s goal is to foster the translation of stem cell biology and research into human clinical applications. The Institute is part of the National Institutes of Health of the US Department of Health and Human Services.
IsoRay, Inc. (ISR) is “One to Watch”
IsoRay, Inc. is utilizing its patented radioisotope technology, experienced chemists and engineers, and management team to create a medical device company focused on providing improved patient outcomes in the treatment of prostate cancer, lung cancer, ocular melanoma cancer, brain cancer, colorectal cancer, gynecological cancer, and other cancers throughout the body. Through its subsidiary, IsoRay Medical, the Company is the sole producer of FDA-cleared Cesium-131 brachytherapy seeds.
IsoRay began production and sales of Cesium-131 brachytherapy seeds in October 2004. The Company is leveraging its technology to capture a leadership position in an expanded brachytherapy market. The more clinically beneficial characteristics of the Cesium-131 isotope are expected to decrease radiation exposure to the patient and reduce the severity and duration of side effects, while treating cancer cells as effectively, if not more so, than Iodine-125 or Palladium-103.
In recent news, IsoRay announced that doctors have performed the world’s first treatment of metastasized brain cancer using its Cesium-131 brachytherapy seeds. The seeds were implanted directly into a woman’s brain to treat a cancer that had originated in the breast. Treatment of metastasized cancers, cancers that originate in other organs, is the latest application of IsoRay’s brachytherapy treatment that represents one of the most important advancements in internal radiation therapy in the last 20 years.
IsoRay CEO Dwight Babcock emphasized that this treatment is only the beginning, predicting that the adoption of Cesium-131 for the treatment of primary and metastasized cancers will continue growing and gain momentum as the medical community becomes aware of the significant advantages it offers in treating cancer sites throughout the body. The pioneering treatment increases life expectancy and limits the potential of recurrence, while improving quality of life and allowing patients to return to normal activities more quickly.
VistaGen Therapeutics Inc. (VSTA) Taps Pharmaceutical Gold Mine
One of the biggest developments in mining today is the re-evaluation and activation of existing gold mines. The reason is obvious. The price of gold has exploded over the past decade, making previously marginal gold mining properties suddenly hot, with huge money making potential, especially when new technologies can be applied. Less well known is the fact that almost exactly the same thing is now happening in the pharmaceutical industry.
What has exploded in pharmaceuticals is the cost of development. Bringing a new drug candidate to market can easily take a billion dollars, sometimes much more, plus well over a decade in time. Making matters worse, after spending vast amounts of money to discover, develop, and validate the efficacy of a new drug, a pharmaceutical company can end up having to shelve it due to unexpected heart or liver toxicity issues. It’s been estimated that fully a third of all potential new drugs fail in preclinical or clinical trials because of safety concerns. It’s a serious problem. Over the past decade, the number of new drugs approved by the FDA has decreased by over 50%, representing billions of dollars in lost opportunity for the industry. If there were a more cost effective and accurate way of assessing possible toxicity problems early on in a drug’s development, allowing researchers to make adjustments before all the money has been spent, many drug candidates could be saved.
It’s a tremendous prospect now being made reality by a California company called VistaGen Therapeutics. VistaGen has come up with a novel way to use advanced stem cell technology for superior predictive toxicology bioassay systems that more closely approximate human biology. It’s a new technology that promises enormous savings in the drug development process and could unlock revenues in the billions of dollars through the re-examination of previously shelved drug candidates for possible non-toxic variants. Like gold mines brought back to life, such drug candidates could mean untold rewards if toxicity issues can be economically resolved, something now being made possible thanks to VistaGen.
To get an idea of what it all could mean for a successful pharmaceutical company, and for VistaGen, consider the top 10 selling drugs in the U.S. The average annual sales for a drug on this list is just under $5 billion.
For additional information, visit the company’s website at www.VistaGen.com
Illumina, Inc. (ILMN) Enters Research Agreement with University of North Texas
Illumina, Inc. is a leading developer and manufacturer of life science tools and systems for the analysis of genetic variation and function. The company provides innovative sequencing and array-based solutions for various analysis of DNA, RNA and protein.
The company announced today it has entered into a wide-ranging collaborative research agreement with the Institute of Applied Genetics and the Department of Forensic and Investigative Genetics at the University of North Texas Health Science Center (UNTHSC). Illumina and UNTHSC will work together on several projects in forensic identification using the company’s next-generation sequencing technology.
The projects outlined in the agreement include studies on a range of forensically relevant markers for human identity testing, microbial forensics, pharmacogenetics for molecular autopsy, and additional markers and methods to generate investigative leads in criminal cases and matters of national security.
Dr. Bruce Budowle of UNTHSC is one of the world’s foremost experts in molecular biology for human identification. He said, “This next-generation sequencing collaboration will lead us to a much stronger forensic DNA testing capability and enable forensic laboratories to apply the most advanced science to assist law enforcement and the forensic medical community.”
For more information on Illumina and its technology, please visit its website at www.illumina.com
SciClone Pharmaceuticals, Inc. (SCLN) Announces Repurchase Program and Reaffirms Previously Released 2011 Financial Guidance
SciClone Pharmaceuticals, Inc., a company that engages in the development and commercialization of novel therapeutics for the treatment of oncology, infectious diseases, cardiovascular, urological, respiratory, and central nervous system disorders, announced that its Board of Directors has given approval to a program that allows the company to repurchase up to $20 million of its common stock over the next 24 month period. Also, SciClone has reaffirmed its previously released 2011 financial guidance with the understanding that any cash utilized to repurchase may decrease the year-end cash balance and that a reduction in shares outstanding may increase full year and fourth quarter earnings per share.
“The share repurchase program demonstrates our confidence in the Company’s strategic plan and our commitment to delivering shareholder value,” commented Friedhelm Blobel, Ph.D., SciClone’s President and Chief Executive Officer. “We remain focused on executing our strategy of creating a market-leading specialty pharmaceutical company in China. With our expanded product portfolio and sales and marketing capabilities through our recent NovaMed acquisition, we believe we are well-positioned for long-term growth.”
Under this program, purchases can be made from time to time in the open market, in private transactions or otherwise, at times and in amounts that the Company sees appropriate. The number of shares that can be purchased and the timing of the purchases may be subject to numerous factors, which may include the price of the common stock, corporate and regulatory requirements, including restrictions in the Company’s debt covenants, general conditions of the market, and alternate investment opportunities. The share repurchase program can be modified or discontinued all together at any time.
SciClone expects its 2011 GAAP revenue to reside between $133 and $138 million (which does not include NovaMed’s revenue prior to the closing of the acquisition on April 8, 2011). Non-GAAP earnings per share for 2011 (which does not include write offs and charges in relation to the acquisition of NovaMed and employee stock-based compensation) is projected to reside between $0.52 and $0.57 per share. Cash, cash equivalents, and short and long-term investments are expected to be more that $55 million at the end of the year 2011. Again, any impact of the stock repurchase program (e.g. use of cash and decreased number of shares of common stock outstanding) is not included in the number provided above.
For more information on SciClone Pharmaceuticals, Inc., visit their company website at: www.sciclone.com
VistaGen Therapeutics Inc. (VSTA) Taps Pharmaceutical Gold Mine
One of the biggest developments in mining today is the re-evaluation and activation of existing gold mines. The reason is obvious. The price of gold has exploded over the past decade, making previously marginal gold mining properties suddenly hot, with huge money making potential, especially when new technologies can be applied. Less well known is the fact that almost exactly the same thing is now happening in the pharmaceutical industry.
What has exploded in pharmaceuticals is the cost of development. Bringing a new drug candidate to market can easily take a billion dollars, sometimes much more, plus well over a decade in time. Making matters worse, after spending vast amounts of money to discover, develop, and validate the efficacy of a new drug, a pharmaceutical company can end up having to shelve it due to unexpected heart or liver toxicity issues. It’s been estimated that fully a third of all potential new drugs fail in preclinical or clinical trials because of safety concerns. It’s a serious problem. Over the past decade, the number of new drugs approved by the FDA has decreased by over 50%, representing billions of dollars in lost opportunity for the industry. If there were a more cost effective and accurate way of assessing possible toxicity problems early on in a drug’s development, allowing researchers to make adjustments before all the money has been spent, many drug candidates could be saved.
It’s a tremendous prospect now being made reality by a California company called VistaGen Therapeutics. VistaGen has come up with a novel way to use advanced stem cell technology for superior predictive toxicology bioassay systems that more closely approximate human biology. It’s a new technology that promises enormous savings in the drug development process and could unlock revenues in the billions of dollars through the re-examination of previously shelved drug candidates for possible non-toxic variants. Like gold mines brought back to life, such drug candidates could mean untold rewards if toxicity issues can be economically resolved, something now being made possible thanks to VistaGen.
To get an idea of what it all could mean for a successful pharmaceutical company, and for VistaGen, consider the top 10 selling drugs in the U.S. The average annual sales for a drug on this list is just under $5 billion.
For additional information, visit the company’s website at www.VistaGen.com
VSTA Taps Pharmaceutical Gold Mine
One of the biggest developments in mining today is the re-evaluation and activation of existing gold mines. The reason is obvious. The price of gold has exploded over the past decade, making previously marginal gold mining properties suddenly hot, with huge money making potential, especially when new technologies can be applied. Less well known is the fact that almost exactly the same thing is now happening in the pharmaceutical industry.
What has exploded in pharmaceuticals is the cost of development. Bringing a new drug candidate to market can easily take a billion dollars, sometimes much more, plus well over a decade in time. Making matters worse, after spending vast amounts of money to discover, develop, and validate the efficacy of a new drug, a pharmaceutical company can end up having to shelve it due to unexpected heart or liver toxicity issues. It’s been estimated that fully a third of all potential new drugs fail in preclinical or clinical trials because of safety concerns. It’s a serious problem. Over the past decade, the number of new drugs approved by the FDA has decreased by over 50%, representing billions of dollars in lost opportunity for the industry. If there were a more cost effective and accurate way of assessing possible toxicity problems early on in a drug’s development, allowing researchers to make adjustments before all the money has been spent, many drug candidates could be saved.
It’s a tremendous prospect now being made reality by a California company called VistaGen Therapeutics. VistaGen has come up with a novel way to use advanced stem cell technology for superior predictive toxicology bioassay systems that more closely approximate human biology. It’s a new technology that promises enormous savings in the drug development process and could unlock revenues in the billions of dollars through the re-examination of previously shelved drug candidates for possible non-toxic variants. Like gold mines brought back to life, such drug candidates could mean untold rewards if toxicity issues can be economically resolved, something now being made possible thanks to VistaGen.
To get an idea of what it all could mean for a successful pharmaceutical company, and for VistaGen, consider the top 10 selling drugs in the U.S. The average annual sales for a drug on this list is just under $5 billion.
For additional information, visit the company’s website at www.VistaGen.com
Zhongpin, Inc. (HOGS) Starts Trial Production of Prepared Pork Products at New Plant in Tianjin
Zhongpin, Inc., a meat and food processing company that specializes in pork and pork products in the People’s Republic of China, announced that it has started trial production at its new prepared pork products plant in Tianjin. The plant cost about $22 million and will produce about 36,000 metric tons annually. Zhongpin will produce sausages, hotdogs and other low-temperature meat products at the new prepared pork facility. Zhongpin reports that this is phase 2 of its industrial park in Tianjin. Phase 1 is the chilled and frozen pork plant that has produced about 100,000 metric tons yearly since it opened in January of 2010.
“We are very pleased with the good market acceptance and growth we have earned so far in greater Tianjin and the North China area. In addition to our chilled and frozen pork, we also sell our prepared pork products in Tianjin that we create in other locations, so we already have a good market presence and foundation there for prepared pork products. For that reason, we believe with confidence that our new facility will yield good market share increases for our prepared pork products in greater Tianjin. We are quite confident that the new facilities in Tianjin will satisfy the traditional strong market demand during the Chinese New Year in early 2012,” stated Xianfu Zhu, Chairman and Chief Executive Officer of Zhongpin Inc in a press release on Friday.
Zhongpin believes the outlook for China’s pork processing industry remains positive. For the year 2011, the company said it expects sales revenues to be in the range of $1.33 billion to $1.37 billion. However, despite Friday’s news, the stock dropped down to a 52 week low.
For more information, please visit www.zpfood.com
NeoStem, Inc. (NBS) Subsidiary Progenitor Cell Therapy Secures Key Brain Cancer Vaccine Manufacturing Agreement with ImmunoCellular Therapeutics
NeoStem, an extremely well-positioned leader in the cell therapy space, via wholly-owned subsidiary Progenitor Cell Therapy, LLC, recently announced a major manufacturing agreement with clinical-stage biotech firm ImmunoCellular Therapeutics, Ltd., a developer of innovative immune-based therapies for brain and other cancers.
Progenitor will serve a key manufacturing role in production during the run up to Phase II clinical trials of ICT-107, obtaining a strong foothold for as a strategic partner for a future Phase III involving the powerful new glioblastoma vaccine, which utilizes a dendritic cell-based targeting of a host of antigens linked to such tumors.
President and CSO of Progenitor, Robert Preti, PhD, pledged to offer the expertise and dedicated service for which the Company is known to ImmunoCellular’s ongoing clinical trialing of ICT-107, citing success stories like the seven-year manufacturing of Provenge for Dendreon’s clinical trials.
Chairman and CEO of NBS, Dr. Robin Smith, echoed her colleague’s sentiments and underscored the immense “manufacturing, regulatory, logistical transport and commercialization for therapeutics development” capacity of Progenitor. Dr. Smith projected solid growth in the client base, led by Progenitor’s reputation, combined with ample East and West Coast production infrastructure and ultimately reinforced by a rapidly emerging consensus in the sector regarding the importance of a skilled manufacturing partner for clinical trialing.
The benefit in terms of cost-effectiveness alone is enough to serve future growth; however, the service, logistics and dynamic scalability also obtained through such a partnership provide unique benefits any company steeped in the complexities of clinical trial procedures can instantly appreciate. The manufacturing agreement is a shrewd move, especially when taken into consideration alongside the greater arc of movement by NBS to dominate the paradigm shift into cell therapies, including the recent Amorcyte, Inc. acquisition, ongoing development of its VSEL™ Technology platform and pursuit of a new T-cell therapeutic with wide-ranging application in a variety of autoimmune disorders.
President and CEO of ImmunoCellular, Manish Singh, PhD, indicated that the use of Progenitor as a secondary manufacturing site for the Phase II study of ICT-107 was seen as mitigating substantial risk, while providing a relational foundation that can see the product into commercialization, making extensive use of the experience already obtained by Progenitor in this area to broadly supplement ImmunoCellular’s own manufacturing efforts.
Singh expressed high confidence that Progenitor’s competencies in autologous cell therapies, cell manufacturing, cell processing and delivery made them the ideal partner to help quickly navigate Phase II and get this important new therapy closer to market.
For more information on the agreement, on NeoStem, Inc., or its subsidiary Progenitor Cell Therapy, LLC, please visit the Company’s website at: www.neostem.com
More information on ImmunoCellular Therapeutics, Ltd. can be found at that company’s website: www.imuc.com
Neuroscience Letters Publishes Peer-Reviewed Study on Rexahn Pharmaceuticals (RNN) Drug Candidate
Rexahn Pharmaceuticals, Inc. announced today the publication of a peer-reviewed study in Neuroscience Letters. The study validates the mechanism of clavulanic acid, the active compound in Serdaxin®, the company’s lead CNS drug.
The published study, entitled “Clavulanic acid increases dopamine release in neuronal cells through a mechanism involving enhanced vesicle trafficking,” shows that clavulanic acid enhances release of neurotransmitters such as dopamine in the brain cell by interacting with key proteins for vesicle trafficking and fusion.
“This study is significant because it confirms at the molecular and cellular levels how Serdaxin enhances the release of neurotransmitters in the brain. Previous studies demonstrated the release of serotonin and dopamine in the brain by clavulanic acid in live animals. These results strongly support that Serdaxin’s CNS effects may be due to an enhanced release of the dual neurotransmitters, called as the SERDA mechanism,” said Dr. Chang Ahn, Chairman and CEO of Rexahn.
Dr. Ahn elaborated, “Because the effectiveness of currently marketed therapies that modulate serotonin reuptake is significantly limited, there exists very strong therapeutic needs for depression patients who are non-responders, are relapsed, or are non-compliant due to adverse reactions of those therapeutics. Serdaxin positions itself to address these therapeutic and safety needs as the first SERDA antidepressant with excellent safety profile.”
Dr. Michael Thase, Chairman of the Depression Scientific Advisory Board of Rexahn, added, “This study illustrates that clavulanic acid may have important effects on monoaminergic neurotransmission, that are the result of interaction with vesicle trafficking and fusion through a novel mechanism involving Munc18 and Rab proteins. Enhancing the release of both dopamine and serotonin to physiological levels in the brain may prove to have novel therapeutic implications for those who suffer from major depressive disorder and other neurological disorders.”
Serdaxin® is currently undergoing Phase II clinical development for major depressive disorder. The compound complement’s Rexahn’s other Phase II trial drug candidates, Archexin® and Zoraxel™. All three compounds have the potential to be “best in class” therapeutics.
Tri-Tech Holding Inc. (TRIT) Secures $1.87M CCTV Production Security Project for New Petroleum Industrial Park in Shaanxi
Tri-Tech Holding, long known as a leading developer of sophisticated turn-key sewage treatment/odor control solutions for some of China’s top municipalities/cities and wielder of an impressive portfolio of intellectual property (2 patents, 27 software copyrights to date), announced that affiliate Beijing Satellite Science & Technology Co., Ltd. (BSST) has secured a $1.87M public bid with the Yanchang Petroleum Group to provide operational/security TV monitoring at a new industrial park in Shaanxi.
The Jingbian Energy and Chemical Industrial Park in Jingbian County, currently under development by Yanchang, will be comprised of a total of six petroleum refining/post-processing plants, collectively capable of yielding million of tons per year of high-value intermediate petroleum products.
TRIT affiliate BSST has been tasked with the essential mission of providing comprehensive CCTV infrastructure, in order to ensure that production security is maintained. The approach outlined by BSST will take the form of a two-pronged systems implementation, with one prong handling production/operational concerns and the other covering perimeter security.
A huge job and a huge boon for BSST, who will provide everything from the design, to materials and implementation/operator commissioning, leveraging the Company’s vast experience in system integration and project installations to deliver by a projected completion date of May, 2013.
CEO of TRIT, Warren Zhao, applauding this second production safety project secured by BSST through Yanchang, spoke of the exemplary progress made thus far with the initial Yanchang project, asserting that the work prompted Yanchang to engage BSST for additional help. Zhao noted that the initial Yanchang project was on schedule for Oct. 2011 completion and pointed to a broadening international focus at TRIT, briefly mentioning ongoing industrial wastewater treatment opportunities being pursued in North America via their Wisconsin-based, J&Y Water Division.
Zhao also pointed to ongoing business development efforts in the Middle East and India, assuring investors that the Company would offer timely press releases concerning prevailing developments with such active bids.
President of TRIT, Gavin Cheng, echoed his colleague’s sentiments roundly and went into greater detail on the industrial CCTV system to be utilized, highlighting in particular the powerful fusion of long range imaging technology and environmental sensors. Cheng underscored the operational benefits of such a system that can detect equipment malfunctions in order to prevent accidents, as well as monitoring production continuously, enabling spills or leakages to be identified and handle if they do occur before the situation gets any worse. Cheng emphasized the importance of such a system to the overall secure operation and performance of the industrial park, and pledged to maintain strict oversight.
For more information on the project, or to find out more about Tri-Tech Holding Inc., please visit the Company’s website at: www.Tri-Tech.cn
Horizon Pharma, Inc. (HZNP) Appoints Grey and Pauli to Board of Directors
Located in Northbrook, Illinois, Horizon Pharma is a biopharmaceutical company that commercializes innovative medicine that targets the unmet therapeutic needs in arthritis, pain and inflammatory diseases. Today, Horizon took another step forward with the announcement they have appointed industry veterans Michael Grey and Ronald Pauli to their Board of Directors.
Michael Grey received his bachelor’s degree in chemistry from the University of Nottingham in the United Kingdom. Since then, Grey has had an impressive career. Grey currently serves as president and chief executive officer at Lumena Pharmaceuticals, Inc. In a career that has spanned more than 3 decades, he has held senior positions at a number of other companies, including president and chief executive officer of SGX Pharmaceuticals, Inc. (sold to Eli Lilly in 2008), president and chief executive officer of Trega Biosciences, Inc. (sold to Lion Bioscience in 2001) and president of BioChem Therapeutic Inc.
Ronald Pauli received a bachelor’s degree in accounting from Michigan State University and went on to earn a master’s degree in finance from Walsh College. Pauli has led an illustrious career and is currently chief business officer at Sagent Pharmaceuticals, Inc., where he was recently promoted from his role as chief financial officer. As CFO, he played a key role in Sagent’s recent initial public offering. In addition, Mr. Pauli has held senior positions at a number of biopharmaceutical companies, including chief financial officer at NeoPharm, Inc. and corporate controller and interim chief financial officer at Abraxis BioScience, Inc., formerly American Pharmaceutical Partners, Inc. Mr. Pauli previously served as corporate controller for Applied Power, Inc. and R.P. Scherer Corporation and also held multiple finance positions at Kmart Corporation.
The appointments of Grey and Pauli come on the heels of Dr. Peter Johann resigning from the Horizon Board of Director’s after an impactful career with the company.
Leading the way at Horizon is Timothy P. Walbert whom serves as the Chairman, President and CEO of the Company. Walbert stated, “We are pleased to welcome Mike and Ron to our board. Their extensive pharma and biopharmaceutical experience in business development, finance and building companies will be an asset to our Board and beneficial to Horizon’s future growth.”
In reference to the resignation of Dr. Johann, Walbert commented, “On behalf of the Board of Directors of Horizon, I would like to thank Peter for his contributions to the Company’s journey to date and we wish him well in his endeavors.”
Currently, Horizon Pharma, Inc. is trading in the $7.48 range. To learn more about the company as a whole, visit their corporate website at: www.horizonpharma.com
Midas Medici Group Holdings, Inc. (MMED) Aims for Senior U.S. Exchange
Midas Medici, a green-oriented IT solutions provider, announced today that it is actively seeking a listing on a senior U.S. stock exchange (NASDAQ or AMEX), once the company meets all applicable listing requirements. The move is meant to increase the company’s visibility in U.S. capital markets, and is a key part of their overall high-growth strategy.
Midas CEO and co-founder, Mr. Nana Baffour, commented on the announcement. “Graduating to a senior U.S. exchange is a high priority for Midas given the tremendous progress we have made growing our business through a combination of organic growth and accretive acquisitions in the United States and Brazil. Midas’ management team and our board of directors are confident that a senior listing will be of tremendous benefit to existing and potential shareholders. Not only would we expect a senior exchange listing to allow us to attract additional investors and increase liquidity, it would also make Midas available to a broader segment of the institutional community as we strive to make further improvements to our revenue, and enhance shareholder value.”
Midas supplies companies and institutions with virtualization, cloud computing, and data management solutions. The company helps optimize IT and data center investments, reducing data loss and cutting energy use, and also works with utilities in the U.S. and Brazil to improve the efficiency of the electric grid through the application of digital technologies.
Midas serves a diverse list of more than 700 clients, from mid-sized to Fortune 1000 companies. Midas’ comprehensive green IT and Smart Grid solutions are provided to customers around the world, including Pepsi, HP, Oracle, PBS, AT&T, Oracle, National Grid, the International Monetary Fund, and many more. The company’s stated mission is to become a leading global provider of green IT and Smart Grid solutions.
For more information on Midas Medici, please visit: www.MidasMedici.com
America's Top Selling Prescription Drugs
http://www.cnbc.com/id/43025869/America_s_Top_Selling_Prescription_Drugs
Scorpex, Inc. (SRPX) Moves Forward with Initiative to Become Fully Reporting; Engages Audit Firm
Scorpex, Inc., an emerging leader of industrial, hazardous and toxic waste disposal services in the Baja Mexico/California region, today announced the engagement of Mantyla McReynolds, a CPA firm based in Salt Lake City, Utah, as its audit firm. An audit from Mantyla McReynolds will allow the Company to file financial reports with the U.S. Securities and Exchange Commission (“SEC”) pursuant to the Securities Exchange Act of 1934 and increase transparency for both current and future investors.
As previously reported, Scorpex engaged the services of the Acadia Group to prepare for its audit and the filing of financial reports with the SEC. According to today’s release, the Acadia Group is working with Mantyla McReynolds to complete the audit as planned during the fourth quarter of this year.
Chief Executive Officer Joseph Caywood stated, “We are pleased to announce the Mantyla McReynolds engagement and look forward to completing the audit. Becoming fully reporting with the SEC is our goal, and engaging Mantyla McReynolds is a priority and significant milestone for our business.”
China Precision Steel, Inc. (CPSL) Reports Strong Increase in Sales
China Precision Steel, Inc. reported higher year over year sales in the fourth quarter of fiscal 2011, as the company benefited from strong demand for many of its product lines.
China Precision Steel reported sales of $46 million in the quarter ending June 30, 2011. This was a 27% year over year increase from the corresponding quarter of 2010, and a 46% sequential increase from the third quarter of fiscal 2011.
China Precision Steel volume also showed a sharp year over year increase, with sales of 49,104 tons in the most recent quarter. This was a 26% increase over the 39,112 tons sold in the fourth quarter of fiscal 2010.
China Precision Steel attributed the better results to strong demand for the company’s cold-rolled steel products. The company manufactures and sells low carbon cold-rolled steel for applications in the home appliance and packaging industries, and high carbon cold-rolled steel for use in the automotive industry.
China Precision Steel said that sales of these two types of products now account for 93% of company sales, down from 98% in the same quarter in fiscal 2010. The company ended the quarter with a $25.6 million backlog of orders.
For more information on the company, go to www.chinaprecisionsteelinc.com
YM BioSciences, Inc. (YMI) Begins Phase II Trial for Its CYT387 Drug
YM BioSciences Inc. is a drug development company. It is currently advancing three clinical stage products: CYT387, a small molecule, dual inhibitor of the JAK1/JAK2 kinases; CYT997, a vascular disrupting agent; and nimotuzumab, an EGFR-targeting monoclonal antibody.
The company today announced that it has enrolled the first of 60 patients in its Phase II trial of CYT387. The drug is to be administered twice daily for the treatment of myelofibrosis. The trial is intended to further evaluate the safety and tolerability of YM BioScienes’ JAK1/JAK2 inhibitor, as well as its efficacy in reducing spleen size, improving symptoms and reducing transfusion dependence in patients with the disease.
In an ongoing Phase I/II trial, CYT387 appears to have a favorable safety profile and has produced a clinically beneficial response in a number of patients. Initial data from this new trial will be used to further enhance YM BioSciences’ pivotal trial designs. The company will acquire additional safety and efficacy data for the drug at doses complementary to those evaluated in the ongoing 166 patient trial.
YM BioSciences’ president and CEO, Dr. Nick Glover, added, “The substantial volume of patient data from the combined studies will be an important component of any future marketing application.”
For more information on YM BioSciences and its CYT387 drug, please visit the company’s website at www.ymbiosciences.com
Sky Power Solutions Corp. (SPOW) Announces Qualification of Sky Power System for French Government Incentives
Sky Power Solutions Corp., a company that engages in developing rechargeable lithium-ion batteries for power production in the United States, has recently announced that its Sky Power system has qualified for incentives from the French Government for solar, renewable energy installation.
Consumers who install the Sky Power system in France can get a 50% government tax credit, potential eligibility for a grant, a loan free of interest, and a possible modest tax- free annual income. A “tax credit” means that, even though you may not pay an income tax in France, the French government will provide you with a sum equivalent to that in cash.
All of this is resulting from a major drive by the French government to raise the amount of renewable energy that is produced each year to comply with EU objectives.
The resale of electricity into the electric grid in France from photovoltaic solar panels has been made available to homeowners since 2006, although until recently the income realized from it was subject to income tax. Provided that the power that is produced does not exceed 3kwh, the income that is received is no longer charged with income tax. The amount of income that could potentially be generated each year is EUR 1500/ EUR 2000 for a 3KW system. “The French government has provided great incentives for homeowners who install the Sky Power system making the time to recover the cost of the unit very short, meaning your Sky Power system becomes a source of extra tax fee income,” says Rich Ralston, PR and Media Manager for Sky Power Solutions.
France utilizes Feed-in-Tariffs for the rates that solar users are paid for the electric power that they sell to the grid. The rates range from: EUR 0.34 to EUR 0.58/KWh, all depending on how the system is integrated. Feed-in-Tariff rates are much higher than the rate that electric power is sold by the utility to residential customers.
The Sky Power system is being developed at the R&D facilities of Li-ion Motors Corp., utilizing the same team that has led the winning 2010 X-Prize for Li-ion Motors in a side-by-side competition by reaching an impressive 187MPGe with their WAVE II fully electric car. Taking advantage of the lessons learned in the development process of one of the most efficient cars to date, Sky Power Solutions has harnessed the mind power to further develop Sky Power, Stand Alone, Residential, Solar Concentrating, Electric Generation system.
The Sky Power Solutions residential solar power station will potentially be able to reduce the average user’s monthly electric grid consumption by up to 30-40% with ZERO emissions and ZERO carbon footprint; utilizing only the Sun’s power. With immense visual appeal, the Sky Power Solutions system can be very easily installed in most backyards, taking up less than one-third of the space that conventional Solar panels take up. The entry-level price point for a Sky Power Solutions-Concentrated Solar electric system has been estimated to be $5,000 at its release. Numerous units can be combined for increased capacity and the amount of electricity that is sold to the grid.
For more information on Sky Power Solutions Corp., visit their website at http://www.skypowersolutions.com
Onyx Service & Solutions, Inc. (ONYX) Set to Build First Diesel-Reduction Solar Project in Honduras with $84 Million Contract
Onyx Service and Solutions, Inc., a global company committed to designing cutting edge energy technology, products, manufacturing advances and construction projects to successfully compete in a global energy marketplace, announced that after a presentation last Wednesday at the Roatan Municipal Government Chambers it is confident that their first major solar power project will be in Honduras. The 18.5 megawatt solar project will earn Onyx $84 million and will allow it to use 65,000 of its branded 280 watt solar panels. Onyx will use this power plant as the entree for the company into a lucrative market of nations that solely use diesel produced electricity for their energy needs.
Honduras is a great first location as a US ally with a huge expat population trying to free itself from the clutches of Venezuela and the influence of Hugo Chavez. Presently, the island of Roatan relies 100% on diesel produced electricity. With diesel prices constantly rising, this total reliance is hurting both the tourist industry and the ability of the nation to attract new businesses. As a top rated retirement location in the world, a fixed cost for energy is an essential attraction. Solar power is a solution to one of the area’s biggest problems.
The next steps for Onyx include the completion of the agreement with the project investors and initiation of the regulatory processes. Onyx has already identified ten-acre tracts that are located in areas with the appropriate exposure to the sun, close to the existing electrical grid and with construction access. The project will be completed in thirds so each tract can be acquired in stages. Each of the stages is expected to utilize 23,500 panels at 280 watts each.
For more information on the Company, please visit www.OnyxService.com
VistaGen Therapeutics, Inc. (VSTA) Announces Expansion of Key Stem Cell Technology Patent Estate Supporting Its Drug Rescue and Cell Therapy Programs
VistaGen Therapeutics, Inc., a biotechnology company applying stem cell technology for drug rescue and cell therapy, was pleased to announce today the issuance of two additional United States patents supporting its therapeutic and drug discovery programs.
U.S. Patent 7,763,466, titled “Mesoderm and Definitive Endoderm Cell Populations,” and U.S. Patent 7,955,849, titled “Method of Enriching a Mammalian Cell Population for Mesoderm Cells,” further enhance VistaGen’s intellectual property portfolio and provide additional protection for its proprietary research and development activities. Methods covered in these important new U.S. patents describe the use of activin and serum-free culture conditions for producing endoderm and mesoderm.
“Strong and enforceable intellectual property rights are critical components of our plan to optimize the commercial potential of our Human Clinical Trials in a Test Tube™ platform,” said Shawn K. Singh, VistaGen’s Chief Executive Officer. “These patents further solidify our growing IP portfolio. Generally speaking, they expand the application of our activin-driven pluripotent stem cell differentiation technology to include a broader range of tissues and organ systems, and significantly strengthen our market position.”
Mesoderm and endoderm are two of the three primary early precursors, “germ layers,” which develop into all of the non-neuronal cells of the body. Endoderm is the innermost of the three primary developmental germ layers, and develops into the gastrointestinal tract, including the major cells of the liver and pancreas, respiratory tracts of the lungs, other endocrine glands and organs, such as the thyroid and thymus glands, the major cells of the kidney and the auditory and urinary systems. Mesoderm is the germ layer lying adjacent to the endoderm. These multi-potential cells develop into cardiac and skeletal muscles, all the cells of blood and lymphatic systems, bone, cartilage, fat, the lining of blood vessels, and connective tissues.
Activins are members of the important transforming growth factor beta (TGF-beta) family of “morphogens,” i.e. developmental factors that direct and control the differentiation and eventual fate of early precursor cells. During development, the body uses differing concentrations of morphogens, similar to activin, to direct precursors to become the various mature cells discussed above. Methods utilizing differing concentrations of activin to direct and control the differentiation of various mature cell types are described in these issued U.S. patents and are widely-believed as having significant commercial value.
In addition to the patent estate that VistaGen owns and controls by license in the U.S., the Company has proprietary rights to a large and growing number of patents granted in territories outside the U.S. Having recently reported its original research demonstrating the use of pluripotent stem cells to generate insulin, these issued U.S. patents further highlight VistaGen’s leadership position in the field as the Company applies its Human Clinical Trials in a Test Tube™ platform for proprietary applications in drug rescue, cell therapy and regenerative medicine.
The patent families related to these two issued patents are subject to exclusive licenses to VistaGen on a worldwide basis through an agreement with Mount Sinai School of Medicine (MSSM) in New York. The patents stem from work conducted by scientists in the laboratory of Dr. Gordon Keller, formerly a Professor of Gene and Cell Medicine at MSSM and Director of its Black Family Stem Cell Institute. Dr. Keller is now Director of the University Health Network’s McEwen Centre for Regenerative Medicine in Toronto and Chairman of VistaGen’s Scientific Advisory Board.
VistaGen Therapeutics, Inc. (VSTA) Announces Expansion of Key Stem Cell Technology Patent Estate Supporting Its Drug Rescue and Cell Therapy Programs
VistaGen Therapeutics, Inc., a biotechnology company applying stem cell technology for drug rescue and cell therapy, was pleased to announce today the issuance of two additional United States patents supporting its therapeutic and drug discovery programs.
U.S. Patent 7,763,466, titled “Mesoderm and Definitive Endoderm Cell Populations,” and U.S. Patent 7,955,849, titled “Method of Enriching a Mammalian Cell Population for Mesoderm Cells,” further enhance VistaGen’s intellectual property portfolio and provide additional protection for its proprietary research and development activities. Methods covered in these important new U.S. patents describe the use of activin and serum-free culture conditions for producing endoderm and mesoderm.
“Strong and enforceable intellectual property rights are critical components of our plan to optimize the commercial potential of our Human Clinical Trials in a Test Tube™ platform,” said Shawn K. Singh, VistaGen’s Chief Executive Officer. “These patents further solidify our growing IP portfolio. Generally speaking, they expand the application of our activin-driven pluripotent stem cell differentiation technology to include a broader range of tissues and organ systems, and significantly strengthen our market position.”
Mesoderm and endoderm are two of the three primary early precursors, “germ layers,” which develop into all of the non-neuronal cells of the body. Endoderm is the innermost of the three primary developmental germ layers, and develops into the gastrointestinal tract, including the major cells of the liver and pancreas, respiratory tracts of the lungs, other endocrine glands and organs, such as the thyroid and thymus glands, the major cells of the kidney and the auditory and urinary systems. Mesoderm is the germ layer lying adjacent to the endoderm. These multi-potential cells develop into cardiac and skeletal muscles, all the cells of blood and lymphatic systems, bone, cartilage, fat, the lining of blood vessels, and connective tissues.
Activins are members of the important transforming growth factor beta (TGF-beta) family of “morphogens,” i.e. developmental factors that direct and control the differentiation and eventual fate of early precursor cells. During development, the body uses differing concentrations of morphogens, similar to activin, to direct precursors to become the various mature cells discussed above. Methods utilizing differing concentrations of activin to direct and control the differentiation of various mature cell types are described in these issued U.S. patents and are widely-believed as having significant commercial value.
In addition to the patent estate that VistaGen owns and controls by license in the U.S., the Company has proprietary rights to a large and growing number of patents granted in territories outside the U.S. Having recently reported its original research demonstrating the use of pluripotent stem cells to generate insulin, these issued U.S. patents further highlight VistaGen’s leadership position in the field as the Company applies its Human Clinical Trials in a Test Tube™ platform for proprietary applications in drug rescue, cell therapy and regenerative medicine.
The patent families related to these two issued patents are subject to exclusive licenses to VistaGen on a worldwide basis through an agreement with Mount Sinai School of Medicine (MSSM) in New York. The patents stem from work conducted by scientists in the laboratory of Dr. Gordon Keller, formerly a Professor of Gene and Cell Medicine at MSSM and Director of its Black Family Stem Cell Institute. Dr. Keller is now Director of the University Health Network’s McEwen Centre for Regenerative Medicine in Toronto and Chairman of VistaGen’s Scientific Advisory Board.
VSTA Announces Expansion of Key Stem Cell Technology Patent Estate Supporting Its Drug Rescue and Cell Therapy Programs
VistaGen Therapeutics, Inc., a biotechnology company applying stem cell technology for drug rescue and cell therapy, was pleased to announce today the issuance of two additional United States patents supporting its therapeutic and drug discovery programs.
U.S. Patent 7,763,466, titled “Mesoderm and Definitive Endoderm Cell Populations,” and U.S. Patent 7,955,849, titled “Method of Enriching a Mammalian Cell Population for Mesoderm Cells,” further enhance VistaGen’s intellectual property portfolio and provide additional protection for its proprietary research and development activities. Methods covered in these important new U.S. patents describe the use of activin and serum-free culture conditions for producing endoderm and mesoderm.
“Strong and enforceable intellectual property rights are critical components of our plan to optimize the commercial potential of our Human Clinical Trials in a Test Tube™ platform,” said Shawn K. Singh, VistaGen’s Chief Executive Officer. “These patents further solidify our growing IP portfolio. Generally speaking, they expand the application of our activin-driven pluripotent stem cell differentiation technology to include a broader range of tissues and organ systems, and significantly strengthen our market position.”
Mesoderm and endoderm are two of the three primary early precursors, “germ layers,” which develop into all of the non-neuronal cells of the body. Endoderm is the innermost of the three primary developmental germ layers, and develops into the gastrointestinal tract, including the major cells of the liver and pancreas, respiratory tracts of the lungs, other endocrine glands and organs, such as the thyroid and thymus glands, the major cells of the kidney and the auditory and urinary systems. Mesoderm is the germ layer lying adjacent to the endoderm. These multi-potential cells develop into cardiac and skeletal muscles, all the cells of blood and lymphatic systems, bone, cartilage, fat, the lining of blood vessels, and connective tissues.
Activins are members of the important transforming growth factor beta (TGF-beta) family of “morphogens,” i.e. developmental factors that direct and control the differentiation and eventual fate of early precursor cells. During development, the body uses differing concentrations of morphogens, similar to activin, to direct precursors to become the various mature cells discussed above. Methods utilizing differing concentrations of activin to direct and control the differentiation of various mature cell types are described in these issued U.S. patents and are widely-believed as having significant commercial value.
In addition to the patent estate that VistaGen owns and controls by license in the U.S., the Company has proprietary rights to a large and growing number of patents granted in territories outside the U.S. Having recently reported its original research demonstrating the use of pluripotent stem cells to generate insulin, these issued U.S. patents further highlight VistaGen’s leadership position in the field as the Company applies its Human Clinical Trials in a Test Tube™ platform for proprietary applications in drug rescue, cell therapy and regenerative medicine.
The patent families related to these two issued patents are subject to exclusive licenses to VistaGen on a worldwide basis through an agreement with Mount Sinai School of Medicine (MSSM) in New York. The patents stem from work conducted by scientists in the laboratory of Dr. Gordon Keller, formerly a Professor of Gene and Cell Medicine at MSSM and Director of its Black Family Stem Cell Institute. Dr. Keller is now Director of the University Health Network’s McEwen Centre for Regenerative Medicine in Toronto and Chairman of VistaGen’s Scientific Advisory Board.
We were informed that BioWorld covered VistaGen's news from earlier this week.
Codexis, Inc. (CDXS) Secures Foothold in Brazilian First Generation Ethanol
Codexis, industrial biotech developer of products which make manufacturing cleaner and more efficient, in conjunction with Raizen Energia S.A., a $12B JV esteemed as Brazil’s largest sugar and ethanol producer, announced signage of a joint development agreement to develop an enhanced first generation ethanol process, shrewdly exploiting Raizen’s solid footprint as the top sugar/ethanol producer in Brazil.
The agreement will see the Codexis CodeEvolver™ platform implemented in order to upgrade the existing process utilized by Raizen for manufacturing ethanol from sugar cane. Pilot production at Raizen’s Bonfim mill will look to accelerate the some 600M gallons of ethanol (2010) produced by Raizen, addressing key areas like improved yeast performance.
CEO of Raizen, Vasco Diaz, cited the timeliness of the agreement as Brazil begins importing ethanol to satisfy demand which is outstripping currently projected yields for the season. Diaz reaffirmed the commitment by CDXS and his company to helping solve the problem through technological innovation.
The agreement calls for commercialization rights to be retained by CDXS, with Raizen accessing preferential commercial terms and subsequent agreements slated to cover any successful developments that emerge under the current agreement. Interestingly, the agreement also includes the potential for collaborative efforts on other lucrative products like bio-based chemicals and similar sugar-derived offerings.
Today’s news is huge for CDXS and its shareholders as Brazil topped out in second place globally last year (2010) for both production (7B gallons) and consumption of ethanol.
President and CEO of CDXS, Alan Shaw, Ph.D., called the agreement a huge step for both Brazilian ethanol production and the two companies. This initial agreement, according to Shaw, will lay the foundation for the future while granting immediate improvement both to the performance and overall cost structure of first generation ethanol.
Raizen is turning out around 530M gallons of ethanol annually, making them Brazil’s third largest fuels company and with a 4,500 station network and 24 sugar mills, they boast an impressive installed capacity of some 900MW of energy from sugar cane. This is a perfect move for CDXS, opening up substantial territory in a thriving market that has real potential for long-term growth.
For more information on the agreement, the technology and/or on Codexis, Inc., please visit the Company’s website at: www.Codexis.com
Scorpex, Inc. (SRPX) Taps Major Market Opportunity in Mexico
Mexico, like any country, has its share of internal challenges. But none of that seems to have dimmed the consensus that the country will play an expanding economic role in North America and the world over the next decade. A growing population gives Mexico a demographic profile that a number of industrialized countries would envy. Its economic fundamentals have generally improved over the last 20 years, in spite of the inevitable effects of the current global economic crisis, with industrial development and privatization continuing to expand.
The result of all this has been a growing need for improved waste handling throughout Mexico, and especially in the Baja Peninsula, a popular tourist and agricultural center with its own growing economy.
Scorpex has clearly recognized the possibilities, and is well along the way toward completing a long anticipated and much in demand full service waste disposal and recycling operation near Ensenada along the northwest coast of Baja, only about 25 miles south of Mexico’s border with California. It will be a state-of-the-art facility, able to process all manner of waste, including toxic and hazardous. Scorpex has financed and is set to install a sophisticated waste gasification and thermal oxidation system, and already has more customers lined up than it can handle. But this is just the beginning. The company’s long term plans call for additional facilities, strategically positioned throughout Mexico.
Taking advantage of Mexico’s expanding waste processing market is not a simple process. In addition to having a clear sense of the market, a major strength of Scorpex is its demonstrated ability to build and maintain a strong and positive working relationship with the Mexican government and local communities, which is necessary to obtain all of the required approvals and a discouragement to potential competitors.
For additional information on Scorpex, visit the company’s website at www.Scorpex.com
Mines Management (MGN) Completes Key Component for Final Phase of Montanore Project
Mines Management Inc., engaged in the business of acquiring, exploring and developing mineral properties containing precious and base metals in Montana, today announced that a Supplemental Draft Environmental Impact Statement (SDEIS) has been completed by the U.S. Forest Service for the Montanore Project.
The SDEIS is a significant component of the Mines Management’s long-standing process with the Montanore Project.
“Completion of the SDEIS is a major step forward in the final phase of the permitting process,” Glenn M. Dobbs, president and CEO of Mines Management stated in the press release. “It signals a move toward completion of the process we began in 2005, since which time we have developed extensive documentation demonstrating the benign nature of this underground mining project, and the protections to the environment provided in the plan of operations.”
The company designed the mine to exceed current standards and regulations to ensure the protection of wildlife while maintaining purity and viability of water in the region, and reduce other perceived risks to the environment. Dobbs also noted how the project will generate employment opportunities.
“Since 1993, the project has undergone additional exhaustive studies, and it is clear the community in the area of the project would like to see the mine built. If developed, the Montanore Project would provide an estimated 350 direct long-term jobs in a community with approximately 20 percent unemployment, resulting in significant economic growth and an increase in the tax base,” Dobbs stated. “With the completion of the SDEIS, we are optimistic that the permitting process is nearing a conclusion, after which the project can move forward.”
Contingent upon obtaining a full permit for the Montanore Project, the company said it intends to complete the rehabilitation and construction of its 14,000 ft. evaluation adit, as well as complete an underground drilling program.
For more information visit www.minesmanagement.com