VistaGen is a biotech company focused on using stem cell technology to generate new, safer variants (drug rescue variants) of once-promising small molecule drug candidates that were developed but ultimately discontinued by large pharmaceutical companies due to heart or liver toxicity issues. VistaGen aims to use their proprietary stem cell technology as a previously unavailable cost effective way to re-examine and ultimately “rescue” such lost drugs, thereby recovering the value from what is usually a substantial prior investment in research and development.

The company recognizes the drug discovery and development crisis facing the U.S. pharmaceutical industry, where increasingly big investments are required for new drug development but not enough new drugs are being finally approved. Using its technology to derive mature human heart and liver cells from pluripotent stem cells, VistaGen continues to develop unique bioassay systems for assessing potential toxicity issues right in the laboratory, providing a way for researchers to successfully modify drug candidates using an economical tweak and test approach.

It’s a development that combines human pluripotent stem cell technology with modern medicinal chemistry to create an important new tool for drug research and development. With human heart cells and liver cells derived from pluripotent stem cells, VistaGen believes that their principal products, CardioSafe 3D™ and LiverSafe 3D™, will allow them to assess the heart toxicity, liver toxicity, and metabolism profile of new drug candidates with greater speed and precision than animal testing and traditional cellular assays currently used in the drug development process.

Although this represents an important new capability that could save the pharmaceutical industry billions of dollars in development costs which might otherwise be lost, VistaGen sees it as a tool that they themselves can use to build a pipeline of resuscitated drug candidates. The company plans to license their drug rescue variants to pharmaceutical companies pursuant to development and marketing arrangements designed to generate optimum revenue. They are also exploring opportunities to advance nonclinical development of potential cell therapy and regenerative medicine pilot programs focused on blood, cartilage, heart, liver, and pancreas cells, based on the proprietary differentiation and production capabilities of their stem cell technology platform.

For additional information, visit www.VistaGen.com

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VistaGen Therapeutics, a biotech company focused on applying stem cell technology for drug rescue, predictive toxicology, and drug metabolism assays, reports that its human pluripotent stem cell-derived cardiomyocytes (heart cells) were used by a collaboration partner, Duke University, to grow a revolutionary three-dimensional (3D) human heart muscle.

Researchers at Duke University used VistaGen’s cardiomyocytes in combination with innovative tissue engineering and cardiac electrophysiology technologies to grow the “heart patch,” which contracts at speed similar to the natural functions of native human heart tissue and provides researchers with a better understanding of the biology necessary to cardiac tissue engineering.

The heart patch also provides potential applications in regenerative cell therapy for heart disease and serves as predictive in vitro assays for drug rescue and development.

“The developed contractile forces and other functional properties of these cardiac tissues are remarkable and are significantly higher than any previous reports,” H. Ralph Snodgrass, PhD, VistaGen’s president and chief scientific officer, stated in the press release. “The achievement of successfully growing a human heart muscle from cardiomyocytes derived from human pluripotent stem cells not only expands the scope of our drug rescue capabilities, but also reflects the advanced nature and potential of our collaboration with the skilled biomedical engineers at Duke Medical Center.”

Dr. Nenad Bursac, associate professor in the Departments of Cardiology and Biomedical Engineering at Duke University, praised the performance of VistaGen’s heart cells in the study.

“VistaGen’s human cardiomyocytes produced engineered cardiac tissues that exhibited functional properties superior to those previously reported,” Dr. Bursac stated.

An abstract of the original research article published in Biomaterials, an international journal covering the science and clinical application of biomaterials, can be found online by scrolling down the page available at this link: http://www.sciencedirect.com/science/article/pii/S0142961213004705.

For more information, visit www.vistagen.com

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Stem cell technology has traditionally been associated with therapeutic regeneration, using these basic building blocks of life to generate new cells that can replace damaged cells. Potential therapeutic applications run the gamut from the replacement of damaged nerve cells to the generation of new heart or liver tissue. However, VistaGen Therapeutics, which is in fact involved in researching and developing therapeutic applications, is best known for a totally different but no less important application of stem cell technology.

Stem cells, in addition to therapeutic applications, can allow scientists to generate mature human cells right in the laboratory; cells that can then be used to efficiently screen drugs for possible toxicity without going through the time and expense involved in human clinical trials, and this is just what VistaGen is focused on doing. The company’s proprietary Human Clinical Trials in a Test Tube stem cell based drug assay platform provides a major advantage to anyone involved in the extremely expensive and risky process of new drug development.

In particular, VistaGen plans to use the technology itself to build a pipeline of drug rescue variants, drugs that have important therapeutic potential but have been shelved due to heart or liver toxicity issues. VistaGen is convinced that it can rescue some of these drugs, using their unique in-lab testing system to economically tweak them, maintaining their demonstrated efficacy while removing their toxicity. VistaGen can then enjoy significant economic participation rights as the new drug is taken to market.

Clearly there are also other rich options the company may soon find itself considering. A powerful technology such as this could result in billions of dollars saved, by helping to avoid the massive costs involved in going to market with a fatally flawed new drug, and such a tool, once finalized, could carry huge licensing potential. In addition, VistaGen could easily become a takeover target, as large pharmaceutical companies look for quick ways to fill profit gaps left by expiring patents.

For additional information, visit www.VistaGen.com

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The strategy of VistaGen Therapeutics, a California based stem-cell technology company, is primed to drive rapid growth because of its unique structure. VistaGen is a developer of stem-cell based bioassay early-warning systems for determining possible toxicity of drug candidates. It provides a distinctive way of determining potential drug toxicity well before the time and expense involved in performing animal or human trials.

The history of the pharmaceutical industry is one littered with drug candidates that were developed, and sometimes even released to the public, only to discover later that there were heart or liver toxicity issues. These drugs were then often shelved, resulting in a massive loss of invested time and money for the pharmaceutical company involved. For drug companies around the world it’s a major problem. However, for VistaGen it represents a major opportunity.

VistaGen’s plan is to use their proprietary Human Clinical Trials in a Test Tube stem cell based platform, a novel bioassay system that provides toxicity testing right in the laboratory, to build a portfolio of drug rescue variants from once-promising but discontinued drug candidates. Considering the fact that development costs for a new drug can easily exceed $1 billion, VistaGen sees these shelved drugs as a veritable diamond mine which it now has the means to tap. It’s like having someone run a 20-mile marathon for you, and then letting you step in near the end to cross the finish line.

Specifically, VistaGen believes each lead drug rescue variant will have the potential to be a viable new drug candidate in which VistaGen can have significant economic participation rights, such as up-front and development milestone payments and royalties on commercial sales. Its valuable technology also sets the company up as a potential takeover target.

For additional information, visit www.VistaGen.com

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The importance of the work being done at VistaGen Therapeutics, developers of stem-cell based bioassay early-warning systems for determining possible toxicity of drug candidates, can be seen in the clinical disasters occasionally experienced by major players in the pharmaceutical industry. A recent article (http://dtg.fm/v3V4) by Valorie Sands in Minyanville, an Internet-based financial media and publishing company, gives an idea of the risks pharmacy companies face, and the need for better and earlier testing.

The article points to the 2010 withdrawal by Pfizer of Thelin (sitaxentan), a medication for treating pulmonary arterial hypertension that had been approved for marketing in Europe, Canada, and Australia, and was undergoing final clinical trials in the U.S., when liver toxicity claimed two lives. In 2008, Pfizer had paid roughly $195 million in a cash tender offer to acquire Encysive Pharmaceuticals to get the drug, which had generated sales of over $44 million for Pfizer in the 9 months prior to its withdrawal.

Another example referred to in the article was a class of highly effective anticancer drugs called anthracycines. In spite of their effectiveness in the treatment of lung cancer, breast cancer, lymphomas, leukemias, and other types of cancers, the use of these drugs is now considerably limited due to the later discovery of significant cardiotoxicity associated with anthracycines.

Overall, toxicity issues end up affecting many new drugs, often late in testing, or even when they have made it all the way to market. The risk is not only to the physical health of patients, but also to the fiscal health of the companies that have invested hundreds of millions in a drug’s development. VistaGen proposes a solution to the problem through its unique Human Clinical Trials in a Test Tube stem cell based platform designed to provide superior heart and liver toxicity testing right in the laboratory, well before clinical trials or market exposure.

For additional information, visit www.VistaGen.com

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VistaGen Therapeutics, a biotechnology company with stem cell technology designed to improve the predictability of the drug development cycle and lower the cost of new drug R&D, just announced the signing of a strategic financing agreement with the European subsidiary of Bergamo Acquisition, a global diversified investment holding company.

Bergamo’s European subsidiary has agreed to invest $36 million in VistaGen in exchange for 72 million shares of restricted VistaGen Common Stock at a price of $0.50 per share. A self-placed strategic financing without any warrants or investment banking fees, this transaction is scheduled to close on or before the last day of this month. At closing, Bergamo will hold the majority of the issued and outstanding shares of VistaGen’s Common Stock.

VistaGen will be using the proceeds of this financing to accelerate and expand its stem cell technology-based drug rescue programs. Using its innovative CardioSafe™ 3D and LiverSafe™ 3D bioassay systems and modern medicinal chemistry, the company is focused on generating new, safer, proprietary variants (Drug Rescue Variants) of once-promising small molecule drug candidates discontinued in development by large pharmaceutical companies due to heart or liver safety issues. In collaboration with co-founder and renowned stem cell research scientist, Dr. Gordon Keller, as well as long-term strategic partner, the University Health Network in Toronto, and several other leading academic and corporate collaborators, VistaGen also plans to advance new pilot nonclinical regenerative cell therapy programs and certain other emerging commercial opportunities related to its Human Clinical Trials in a Test Tube™ platform.

“Since our inception nearly 15 years ago, we have carefully deployed more than $53 million, including over $15 million from grant awards and collaboration revenue, to successfully develop innovative stem cell technology and bioassay systems capable of bringing clinically relevant human heart and liver biology to the front end of the drug development process,” commented Shawn K. Singh, VistaGen’s Chief Executive Officer. “Upon the closing of this transformative financing, our strong long-term financial position will enhance substantially our ability to drive our core programs to valuable commercial outcomes.”

For more information, visit www.VistaGen.com

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VistaGen Therapeutics is a California biotechnology company focused primarily on the use of its proprietary pluripotent stem cell technology to discover, rescue, and develop novel drug candidates for a wide range of diseases.

The core of the company’s strategy is the use of its Human Clinical Trials in a Test Tube stem cell based platform that is designed to function as a superior assay system for determining heart or liver toxicity right in the laboratory, prior to lengthy and expensive animal tests or clinical trials. With this advanced and accurate technology, exclusive to VistaGen, the company plans to identify and develop a broad pipeline of drug rescue variants from small molecule drug candidates that were shelved due to toxicity concerns but which can now be re-evaluated and potentially modified to generate variants that are both effective and safe.

Such a technology, once perfected, represents a potentially massive market due to the astronomical costs involved in developing and bringing a new drug to market, a process that can burn through billions of dollars for a single drug. After investing so much time and money, it’s not unusual for a drug to ultimately fail due to toxicity issues that didn’t show up in early testing. All of this has put the pharmaceutical industry under tremendous pressure, slowing the approval process, reducing drug pipelines, and threatening billions of dollars in market share.

VistaGen’s advanced cell technology represents significant leverage in the development process, a leverage the company intends to use to help the pharmaceutical recover prior investment in discontinued drugs with positive efficacy data. The company believes that each such drug will have the potential to be a new drug candidate in which they can have economic participation rights (upfront and development milestone payments and royalties on commercial sales).

For additional information, visit www.VistaGen.com

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Why do pharmaceutical drugs cost so much? Because pharmaceutical companies waste so much money and time developing them.

But these companies can be excused for wasting hundreds of millions of dollars and years of work developing drugs that won’t be approved for use. The conventional method for initially testing the effectiveness and toxicity of these drugs – testing on animals – is terribly ineffective.

While scientific models like animals can provide a clue of how a drug might affect a human, they can never truly replicate the effects of giving the drug to people. Drugs that might not work in animal models – or even cause harmful effects – could produce an entirely different outcome when given to humans. But before government regulators will allow a drug to be tested on humans, it has to be proven safe in costly clinical trials with animal models or in vitro cell culture testing systems.

Drugs are scrapped every year by pharmaceutical companies after toxicity issues are discovered. The drugs are soon forgotten as the companies move on to find the next “wonder drug.” If scientists had a more accurate scientific model to perform initial tests on, they would be able to better predict which drugs are safe and which aren’t long before large investments are made.

A San Francisco-based biotechnology company, VistaGen Therapeutics, is focused on changing all of this through its novel platform Human Clinical Trials in a Test Tube™. The platform uses proprietary and exclusively-licensed stem cell technologies, some co-developed by Dr. Gordon Keller, a world renowned stem cell scientist.

In addition to providing toxicity predations for new drugs, the platform is designed to “rescue” once-promising small molecule drug candidates that were shelved because they exhibited negative effects in studies using conventional scientific models. Development of these drug candidates are often halted due to signs of heart or liver toxicity or metabolism issues during tests using scientific models like animals or in vitro cell culture testing systems.

The Human Clinical Trials in a Test Tube platform enables controlled differentiation of pluripotent stem cells into mature human cells, which are a more accurate model for clinical trials. The platform helps scientists determine if the negative effects experienced in previous trials with conventional models apply to humans. It can also be used to help generate new, safer variants in combination with modern medicinal chemistry.

By developing scientific models which more closely approximate human biology, VistaGen is helping pharmaceutical companies more accurately assess how new drug therapies will perform in clinical trials. The Human Clinical Trials in a Test Tube platform also provides useful clinical data earlier in the drug development process – so drug companies will know sooner which drugs might work … and which drugs won’t. Having this information much sooner in the development cycle will help increase the efficiency of clinical trials and eliminate the waste of valuable resources.

For more information, visit VistaGen at www.VistaGen.com

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VistaGen Therapeutics, a biotechnology company applying stem cell technology for drug rescue, predictive toxicology, and drug metabolism assays, has been scheduled to present key enhancements to LiverSafe 3D™, its human liver cell-based bioassay system designed to predict liver toxicity and drug metabolism issues, in a poster presentation at the Society of Toxicology’s 52nd Annual Meeting today at 2:00pm EDT.

Dr. Kristina Bonham, Senior Scientist, Hepatocyte Biology Project Leader, will present VistaGen’s poster entitled “Selection of CYP3A4+ hESC-derived Hepatocytes for Drug Metabolism and Toxicity Assays,” which will detail the following expanded data:

• 3A4BLA-hepatocytes (human liver cells) can be used to: monitor the differentiation of mature hepatocytes; sort for mature hepatocytes; monitor drug induction of the CYP3A4 gene, the crucial adult enzyme responsible for metabolizing approximately 50% of existing drugs; and develop in vitro assays for drug metabolism and toxicity

• Using appropriate reagents, the 3A4BLA system can be used to select and enrich stem cell-derived functionally mature hepatocytes

“These data demonstrate that we have substantially improved our LiverSafe 3D™ and now have the potential to identify and purify human hepatocytes with more mature functions, as well as provide a novel assay for drugs that effect CYP3A4 enzyme expression, activity and key drug-drug interactions,” H. Ralph Snodgrass, PhD, VistaGen’s President and Chief Scientific Officer, stated. “I am excited by the fact that further improvements in our differentiation protocols have enabled our scientists to produce cultures with more than 80% mature hepatocytes expressing CYP3A4 without cell enrichment, which will dramatically accelerate our initiation of drug rescue programs focusing on both liver and heart toxicity.”

For more information, visit www.VistaGen.com

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VistaGen Therapeutics, a biotechnology company applying stem cell technology for drug rescue, predictive toxicology, and drug metabolism assays, just announced it will feature key developments involving CardioSafe 3D™, its pluripotent stem cell-based bioassay system for heart toxicity, in a poster presentation at the Society of Toxicology’s 52nd Annual Meeting, the world’s premier toxicology conference, in San Antonio, Texas, today at 7:30 am PDT.

VistaGen’s poster titled “Development of Improved hESC-Based High-Throughput Screening Assays for Cardiotoxicity Assessment,” will be presented by Dr. Hai-Qing Xian, Senior Scientist. The presentation will discuss the following expanded functional and electrophysiological results:

• Optimized differentiation protocols that, without selection, reproducibly yield more than 80% human cardiomyocytes (human heart cells) that function reliably in various established and newly developed assays relevant to cardiac drug effects
• The use of patented technology involving the CD172a cell surface marker, allows the purification of substantially pure (more than 95%) human cardiomyocytes
• The development of a series of fluorescence or luminescence-based high-throughput assays that are used to assess drug-induced: 1) necrosis; 2) apoptosis; 3) mitochondrial toxicity; and 4) oxidative stress of human cardiomyocytes
• New assays are validated using compounds that include: 1) inhibitors of protein kinases; 2) DNA intercalating agents; 3) ion-channel blockers; and 4) compounds that block the surface expression of critical ion-channels
• The assays measured drug effects with high sensitivity, yielding results consistent with known human biology of the compounds

H. Ralph Snodgrass, PhD, VistaGen’s President and Chief Scientific Officer, stated, “I am very pleased with these results, because they confirm that our stem cell-based human cardiomyocyte screening systems will provide improved capabilities and resolution for our cardiac drug rescue programs, which we believe will contribute to the efficient and rapid identification of safer and highly effective new drug therapies.”

For more information on VistaGen and its stem cell-based bioassays, visit www.VistaGen.com

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Today before the opening bell, VistaGen Therapeutics, a biotechnology company applying stem cell technology for drug rescue, predictive toxicology, and drug metabolism assays, announced it has entered a new collaboration agreement with Celsis In Vitro Technologies (“Celsis”), the premier global provider of specialized in vitro products for drug metabolism, drug-drug interaction, and toxicity screening. The two companies aim to characterize and functionally benchmark VistaGen’s human liver cell platform, LiverSafe 3D™, for studying and predicting human liver drug metabolism.

Utilizing Celsis’ experience and expertise in in vitro drug metabolism, VistaGen aims to demonstrate the accuracy of its human liver cell platform. In this strategic collaboration Celsis will not only validate VistaGen’s stem cell-derived liver cells in traditional pharmaceutical metabolism assays, but will also determine genetic variations in VistaGen’s pluripotent stem cell lines that are important to drug development. VistaGen also will utilize Celsis’ human cadaver-derived liver cells, currently used throughout the pharmaceutical industry for traditional drug metabolism assays, as reference controls with which to monitor and benchmark the functional properties of LiverSafe 3D™.

With the assistance of Celsis scientists, VistaGen aims to achieve four key objectives:

• Optimize techniques to handle and maintain primary human cadaveric liver cells as reference controls for various drug development assays;
• Develop a stable supply of characterized and validated human cadaveric liver cells to serve as internal controls and provide benchmark comparisons for the characterization of VistaGen’s pluripotent stem cell-derived liver cells;
• Characterize VistaGen’s liver cells using many of the same industry standardized assays used to characterize primary human cadaveric liver cells; and
• Produce a joint publication of the characterization of VistaGen’s stem cell-derived human liver cells.

“As an industry leader in the development of in vitro primary hepatocyte technology, Celsis has extensive resources to aid us in the benchmarking of our novel liver cell-based platform to industry standards,” stated H. Ralph Snodgrass, PhD, VistaGen’s President and Chief Scientific Officer. “We anticipate this collaboration will lead to the further validation of our LiverSafe 3D™ system for predicting liver toxicity and drug metabolism issues long before costly human clinical trials.”

“This is another example of our long-term dedication to using the power of human pluripotent stem cells as the basis of more predictive in vitro tools for drug discovery and development,” concluded Dr. Snodgrass.

For additional information, visit www.VistaGen.com

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When it comes to the pharmaceutical world, few things are more important than current and future relationships with other companies and organizations. For emerging companies, partnerships are often critical, helping to drive research and build portfolios. On the other hand, future potential relationships, in the form of takeovers or the sale of licensing rights, can represent a company’s primary payoff for all of its hard work. An example of such a payoff is Biogen Idec’s recent agreement to pay Elan Corp. a whopping $3.25 billion for its stake in the multiple sclerosis medicine Tysabri. Flush with the new money, Elan is now able to itself go hunting for possible acquisitions.

None of this is lost on VistaGen Therapeutics, a California-based developer of advanced stem cell technologies designed to provide superior drug testing options for pharmaceutical companies, allowing drug candidates that were previously shelved due to toxicity issues to be economically rescued. The company’s goal is to use the technology to generate a diverse drug pipeline consisting of new, proprietary, small molecule variants (Drug Rescue Variants) of once-promising drug candidates. The market potential is unlimited.

On the research and development side, VistaGen has surrounded itself with a network of successful partnerships, accelerating technological development and also establishing key contacts throughout the industry.

Partnerships with commercial entities include the following:

• Cato Research, a contract research organization, provides regulatory and drug development expertise and also acts as a source of potential drug rescue candidates and collaborations.
• ChanTest provides services that range from early functional screens for profiling drug candidates or ranking within profiles during the drug-discovery process – to a complete set of in vitro GLP service products for cardiac risk assessment.
• NuPotential, LLC, addresses the high-growth cell therapeutics market by developing new systems for evaluating and directing human cell reprogramming.
• Synterys is a medicinal chemistry and collaborative drug discovery provider focused on the needs of virtual and small drug discovery companies.
• TET Systems offers technology that provides efficient, precise, and reversible control over both timing and level of gene expression in eukaryotic cells.

For additional information on these and other partnerships, visit the company’s website at www.VistaGen.com

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If there is one thing that seems to define modern health care, it’s costs. Today, there are options that never had to be considered in the past, but options that come at a price. High-tech healthcare costs money, but most people are also glad to have such options available and wouldn’t want to go back to the old days. However, there is one area of cost that is especially controversial. The fast rising cost of pharmaceuticals is difficult for most people to appreciate. After all, one pill looks pretty much like another. But the pharmaceutical industry is quick to point out a range of factors that have fed the frightening increase in the price paid for these pills.

First and foremost is the exploding cost of research and development. One study suggests that the average cost of bringing a new drug to market has risen from $199 million in the 1970s, itself an impressive figure, to almost $1.9 billion. Further studies suggest that this 10-fold jump is due to several factors, including more time spent in clinical testing plus stricter regulations that can end up ruining years of research. The fact is drug development is far riskier today, with the chances of success much smaller than they used to be. It takes twice as long to get an approval, and the odds of getting approved at all are only about one in ten.

VistaGen Therapeutics offers a major source of help in potentially reducing these costs. The company has used its advanced proprietary stem cell technology to create a unique testing platform for new drug development called Human Clinical Trials in a Test Tube. It will allow drug development companies to greatly reduce the risks involved in drug development by giving them a way to test drugs on real human tissues while still in the lab, long before any clinical trials. Companies can thereby avoid the chance of spending huge amounts of money developing a drug only to have it get pulled in clinical trials due to heart or liver toxicity.

For additional information, visit www.VistaGen.com

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The advent of stem cell technology is proving to be one of the most foundational developments in the history of modern medicine. Like the stem cell itself, this rapidly developing technology is showing a remarkable ability to transform itself, revealing new opportunities in a rising number of medical applications. Although some awareness of the ability of some cells to change into other cells has been known for a long time, it’s only been in the past several decades that researchers have begun to appreciate the range of capabilities that stem cells represent. The result has been an explosion of possibilities in our understanding and work with the human body.

Perhaps best known is the work being done in the field of regenerative medicine, using stem cells to replace or regenerate damaged human cells. Potential applications are wide spread, from the use of stem cells to help control diabetes, to the healing of damaged hearts, to dealing with the many diseases associated with nerve or brain cell damage.

In some cancers, such as certain leukemias and lymphomas, damaged stem cells that are no longer able to do their job can be removed and replaced with healthy stem cells. Stem cell transplants are becoming an increasingly important cancer therapy.

Stem cells are also being used in research. By using pluripotent stem cells to create various specific cell types, researchers can perform any number of complex medical experiments that would otherwise be difficult or even impossible to perform.

Today there is yet another field of growing interest: the use of stem cells for early drug testing, an area focused on by VistaGen Therapeutics. VistaGen has developed a way to use its proprietary human pluripotent stem cell technology to develop an advanced testing platform called Human Clinical Trials in a Test Tube™. It allows drug development companies to test the effects of new drug candidates on real heart and liver cells without having to wait for clinical trials. This represents a huge money-saving advantage, avoiding the expense involved in developing a drug only to have it fail due to heart or liver toxicity, a major problem in the industry. The goal of VistaGen is to use this technology to discover, rescue, and develop novel drug candidates for a wide range of diseases.

For additional information, visit www.VistaGen.com

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VistaGen Therapeutics, a biotechnology company applying stem cell technology for drug rescue, predictive toxicology, and drug metabolism assays, earlier today announced significant advancements in its stem cell technology licensed from the University Health Network (UHN) in Toronto, Canada. The advancements improve the company’s ability to develop new stem cell-based bioassay systems and potentially improved cell therapies for human blood system disorders.

“In collaboration with our long-term strategic partners at UHN, we continue to pioneer stem cell technology that promises to change the way we develop medicine and apply treatment,” stated Shawn K. Singh, CEO of VistaGen. “In addition to creating new capabilities and in vitro assays for drug rescue and predictive toxicology, these advancements open the door to development of new treatments for bone marrow failure, anemia, viral diseases and other conditions that compromise the immune system.”

“Due to only partial understanding of the timing and control of the development of definitive hematopoiesis in humans, scientists were previously limited in their ability to identify and produce, from human pluripotent stem cells, the important precursor for mature red and white cells of the blood,” commented H. Ralph Snodgrass, PhD, VistaGen’s President and Chief Scientific Officer. “The identification and characterization of this important precursor provides a readily accessible pluripotent stem cell-derived target cell population that can be expanded and matured into the types of cells needed for novel in vitro assays and our drug rescue efforts, and enables improved technologies and approaches for future cell therapy collaborations.”

Dr. Gordon Keller, Chairman of UHN’s McEwen Centre for Regenerative Medicine in Toronto and co-founder of VistaGen, added, “We’ve been working for many years studying in vitro differentiation of pluripotent stem cells trying to identify, and then expand, the first human cell capable of producing the adult blood and immune system. I believe that we now have a better understanding of this important transition from embryonic to adult hematopoiesis, and have the tools to develop improved methods to expand this cell in large numbers for both drug development and cell therapy applications.”

For more information, visit www.VistaGen.com

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A recent article by Ryan McBride in biotech industry newsletter FierceBiotech (http://dtg.fm/i12W) highlights a major transition that needs to occur in the pharmaceutical industry.

The article points to a speech by Ken Kaitin, director of the Tufts Center for the Study of Drug Development, suggesting that drug development companies need to fix broken areas of development that are costing them billions of dollars from unnecessary procedures in clinical trials. Kaitin’s group expects pharma to replace traditional trial-and-error testing methods with newer approaches, such as biomarkers, modeling, and simulation, all in an effort to reduce failures and associated costs, costs which payers are increasingly reluctant to accept.

It’s exactly the issue that is being addressed by VistaGen Therapeutics’ proprietary stem cell technologies. VistaGen is a California-based biotechnology company applying its human pluripotent stem cell technology for drug rescue applications, including predictive toxicology and drug metabolism screening. The company intends to use its proprietary technology to discover, rescue, and develop novel drug candidates for a wide range of diseases.

The company’s platform, Human Clinical Trials in a Test Tube, is based on the differentiation of human pluripotent stem cells into multiple types of mature human heart and liver cells which can then be used to provide clinically relevant predictions of potential toxicity. Determination of toxicity at these early stages, far earlier than standard clinical trials, means that drug candidates have a chance of being modified for a successful outcome, saving tremendous amounts of money.

Many otherwise promising drug candidates have been shelved due to toxicity issues that surfaced well into the development and introduction process, representing major losses for drug companies. It suggests a growing recognition of the incredible value offered by technologies such as those VistaGen represents.

For additional information, visit www.VistaGen.com

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A recent article published by Seeking Alpha, titled “Supreme Court Decision Is Bullish For Stem Cell Companies,” reviews the recent high court decision that allows medical universities and science foundations to receive federal funding for embryonic stem cell research. Now supported by the federal government, the stem cell industry is anticipated to be a $6.6 billion market by 2016, more than 50% greater than its present size.

To read the complete article, visit: http://seekingalpha.com/article/1120881

Peter Harengel, author of the article, provided an overview of the progress taking place in the industry as companies continue to move forward with their stem cell research. VistaGen Therapeutics, for instance, recently announced a significant advance in its development of LiverSafe 3D™, a human liver cell-based bioassay system designed to predict liver toxicity and drug metabolism before animal or human testing. As with its CardioSafe 3D™ product, this bioassay system was designed to be used with modern medicinal chemistry to generate safer, proprietary chemical variants (“drug rescue variants”) of once-promising drug candidates, as well as identify product failures earlier in the cost curve.

Companies active in stem cell research are now much more attractive for a variety of factors. The election in Washington, D.C. has brought clarity to the health care sector, overall. The major players know what to expect and can now move forward. The recent Supreme Court decision will now focus the attention of many on stem cell research as more federal funding will enter the sector. Also of significance is that the political uncertainty is gone regarding stem cell research.

2013 is poised to introduce a new flood of excitement in this up-and-coming health care market.

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VistaGen Therapeutics, a biotechnology company applying stem cell technology for drug rescue, predictive toxicology, and drug metabolism screening, excitedly reported today the successful completion of its final Phase 1 safety study of AV-101, a novel orally available prodrug candidate being developed for treatment of multiple conditions involving chronic neuropathic pain. AV-101 has been found to be safe and well tolerated, with favorable bioavailability and pharmacokinetics.

“This important confirmation of AV-101’s safety is the final step in our Phase 1 program for AV-101,” stated Shawn K. Singh, JD, VistaGen’s Chief Executive Officer. “With $8.8 million of funding from the National Institutes of Health (NIH) and outstanding strategic development and regulatory support from Cato Research Ltd., we have successfully completed the required studies enabling Phase 2 clinical development of AV-101 for multiple large market neurological diseases and conditions. In addition, recent data from the NIH suggest that the same neural pathway modified by AV-101 may be useful for treating depression. Launching a broad strategic collaboration to advance development and commercialization of AV-101 is among our key goals in 2013.”

Mark S. Wallace, MD, Chair of the Division of Pain Medicine, Department of Anesthesiology at UCSD and the principal investigator of the study, commented, “The primary safety and tolerability endpoints of the Phase 1 program were met. This is a very safe compound with no observed side effects. AV-101 is an exciting prodrug compound that acts through a promising mechanism to treat pain. I am excited to move this compound into Phase 2 studies for the treatment of pain.”

VistaGen’s final AV-101 Phase 1 safety study was a randomized, double-blind, placebo-controlled, dose-escalation clinical trial conducted at the University of California, San Diego (UCSD). The study involved three cohorts of healthy volunteers, each receiving multiple daily treatments of one of three dose levels of orally administered AV-101 over a 14-day period. The primary objectives of the study were to evaluate the safety, tolerability, and pharmacokinetics (PK) of three different daily doses of AV-101 compared to placebo controls. A total of 46 healthy volunteers completed the study. The oral administration of AV-101 was safe and well tolerated by all subjects at all three dose levels tested. In addition, the PK of AV-101 was fully characterized across the range of three dose levels in the study. The data indicate that AV-101 had good bioavailability and a favorable PK profile.

Aimed at multi-billion dollar neurological disease and disorders and depression markets, AV-101 is a novel, orally available prodrug that is converted in the brain into an active metabolite, 7-chlorokynurenic acid (7-Cl-KYNA), which regulates an important neurotransmitter in the brain called the N-methyl-D-aspartate (or NMDA) receptor. A synthetic analogue of kynurenic acid, a naturally occurring neural regulatory compound, 7-Cl-KYNA is one of the most potent and selective blockers of the regulatory GlyB-site of the NMDA receptor.

VistaGen’s AV-101 IND application covers clinical development for neuropathic pain. In addition to neuropathic pain, VistaGen expects the results of its Phase 1 clinical program to be useful for supporting the development of AV-101 for other neurological disorders including depression and epilepsy.

For more information, visit www.VistaGen.com

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Today before the opening bell, VistaGen Therapeutics, a biotechnology company applying stem cell technology for drug rescue, predictive toxicology, and drug metabolism screening, told investors that Shawn K. Singh, CEO of VistaGen, will be stepping into the spotlight at Noble Financial Capital Markets’ Ninth Annual Equity Conference.

Mr. Singh’s presentation will provide a comprehensive overview of the company’s progress and unique opportunities to apply its stem cell technology platform, Human Clinical Trials in a Test Tube™, for drug rescue, predictive toxicology, and drug metabolism screening. He will present at 12:30 pm EST on Wednesday, January 23, 2013, at the Hard Rock Hotel in Hollywood, Florida.

Those who wish to access the presentation materials as well as tune-in remotely via a live audio and video webcast should visit VistaGen’s website at www.vistagen.com and Noble Financial’s website at www.noblefcm.com. Investors and analysts should register approximately 10 minutes before the start of the presentation to ensure timely access.

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California-based VistaGen Therapeutics, a biotechnology company applying proprietary human pluripotent stem cell technology for drug rescue, predictive toxicology, and drug metabolism screening, has been highly effective in pro-actively partnering with important academic and government research institutions to help the company strengthen the breadth and depth of its proprietary stem cell technology platform, Human Clinical Trials in a Test Tube™.

• California Institute for Regenerative Medicine (CIRM) – CIRM funds stem cell research programs throughout California, with a focus on new therapies for chronic disease and injury. The institute’s mission is to support and advance stem cell research and regenerative medicine under the highest ethical and medical standards for the discovery and development of cures, therapies, diagnostics, and research technologies.

• Centre for Commercialization of Regenerative Medicine (CCRM) – CCRM is a Canadian non-profit organization supporting the development of technologies to accelerate the commercialization of stem cell and biomaterial based products and therapies.

• McEwen Centre for Regenerative Medicine (MCRM) – MCRM is a Toronto-based organization with a mission to be a catalyst for regenerative medicine by facilitating collaboration, supporting research, and promoting awareness of the field.

• Mount Sinai School of Medicine – Home to an array of leading research institutes, centers, and laboratories, Mount Sinai School of Medicine is working toward translating advances in basic science into innovative patient care.

• National Institutes of Health (NIH) – The largest source of funding for medical research in the world, NIH is made up of 27 institutes and centers. For over a century, NIH scientists have paved the way for important discoveries that improve health and save lives.

• National Jewish Health – Known worldwide for the treatment of patients with respiratory, cardiac, immune, and related disorders, as well as for groundbreaking medical research, National Jewish Health is currently the only facility in the world dedicated exclusively to these disorders.

• University Health Network (UHN) – Building on the strengths and reputation of each of its three hospitals, UHN brings together the talent and resources needed to achieve global impact and provide exemplary patient care, research, and education.

• Wisconsin Alumni Research Foundation (WARF) – WARF serves the University of Wisconsin-Madison scientific community by patenting the discoveries of UW-Madison researchers and licensing these technologies to leading companies in Wisconsin, the United States, and worldwide.

To view other business collaborations in place, visit http://dtg.fm/vsta-strategic-partners

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lot of great things have been happening with VistaGen Therapeutics recently. VistaGen is a California-based biotechnology company actively applying its proprietary human pluripotent stem cell technology to launch a new era of drug rescue, predictive heart and liver toxicology, and drug metabolism screening.

VistaGen’s unique stem cell technology-based Human Clinical Trials in a Test Tube™ platform currently involves controlled differentiation (development) of pluripotent stem cells into mature, functional human heart and liver cells that can then be used to predict early in development whether a drug candidate has potential toxicity problems. Determination of potential heart and liver toxicity early on in the development process, far earlier than standard tests, means that drug candidates have a chance of being modified for a successful outcome long before resources are expended on costly and time-consuming animal and human clinical studies. Many otherwise promising drug candidates have been shelved due to heart or liver toxicity issues that surfaced well into the development process and even after FDA approval, representing major losses for drug companies.

By generating new chemical variants of small molecule drug candidates that have shown promise, but are currently on hold due to heart or liver toxicity issues, VistaGen can effectively rescue substantial prior investment by others in discovery and development of the once-promising drugs, building an exclusive and valuable portfolio of proprietary rejuvenated drug candidates. VistaGen plans to have economic participation rights to all of the drug rescue variants it develops, benefitting its bottom line as well as its shareholders. The tremendous promise of this approach has prompted the company’s CEO, Shawn Singh, to purchase 100,000 additional common stock shares of the company, bringing his total holdings to 252,174 shares.

Other recent developments include the company’s formalized membership in the Toronto-based Centre for Commercialization of Regenerative Medicine’s (CCRM) Industry Consortium. VistaGen aims to expand the commercial applications of their Human Clinical Trials in a Test Tube™ platform by building multi-party collaborations with CCRM and members of its Industry Consortium around drug rescue and regenerative medicine opportunities, including pilot nonclinical programs involving blood, heart, liver, and potentially pancreatic beta islet cells. Speaking of these opportunities, Shawn Singh emphasized that such collaborations have the potential to “transform medicine and accelerate significant advances in human health and wellness that stem cell technologies and regenerative medicine promise.”

In addition, the company had earlier announced the completion of a $3.25 million financing commitment from its largest institutional investor, Platinum Long Term Growth VII, LLC.

For additional information on VistaGen’s stem cell technology and current initiatives, visit www.VistaGen.com

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VistaGen Therapeutics, a biotechnology company applying stem cell technology for drug rescue, predictive toxicology and drug metabolism screening, today announced its membership in the Toronto-based Centre for Commercialization of Regenerative Medicine’s (CCRM) Industry Consortium.

“VistaGen’s membership reflects our strong association with CCRM and its core programs and objectives, both directly and through our strategic relationships with Dr. Gordon Keller and the University Health Network (UHN). Our long-term sponsored research agreement with Dr. Keller, UHN and UHN’s McEwen Centre for Regenerative Medicine offers both a solid foundation and unique opportunities for expanding the commercial applications of our Human Clinical Trials in a Test Tube™ platform by building multi-party collaborations with CCRM and members of its Industry Consortium,” stated Shawn Singh, VistaGen CEO. “These collaborations have the potential to transform medicine and accelerate significant advances in human health and wellness that stem cell technologies and regenerative medicine promise.”

“Even before VistaGen joined CCRM’s Industry Consortium it was active in the Toronto regenerative medicine community and advising us as we prepared to launch in 2011,” commented Dr. Michael May, CEO of the Centre for Commercialization of Regenerative Medicine. “I’m confident that our relationship will grow stronger with VistaGen as a formal partner and I look forward to us working closely together on projects that will accelerate drug discovery and benefit patients.”

CCRM is funded by the Government of Canada, six Ontario-based institutional partners, and more than 20 companies representing the key sectors of the regenerative medicine industry. CCRM supports the development of foundational technologies that hasten the commercialization of stem cell-based and biomaterials-based products and therapies. Notable members of CCRM’s Industry Consortium include Pfizer, GE Healthcare, and Lonza.

The industry leaders that comprise the CCRM consortium benefit from proprietary access to certain licensing opportunities, academic rates on fee-for-service contracts at CCRM and opportunities to participate in large collaborative projects, among other advantages. VistaGen is especially well positioned through its existing relationships with key members.

Gordon Keller, Ph.D. is Director of the McEwen Centre for Regenerative Medicine at UHN. A CCRM partner, the McEwen Centre is a world-renowned centre for stem cell biology and regenerative medicine and a world-class stem cell research facility. He is also a Professor at the University of Toronto in the Department of Medical Biophysics and Senior Scientist of the Ontario Cancer Institute in Toronto. Dr. Keller’s lab is one of the world leaders in successfully applying principles from the study of developmental biology of many animal systems to the differentiation of pluripotent stem cell systems, resulting in reproducible, high-yield production of human heart, liver, blood and vascular cells. The results and procedures developed in Dr. Keller’s lab are often quoted and used by academic scientists worldwide.

UHN, a major landmark in Canada’s healthcare system, is one of the world’s largest research hospitals, with major research in transplantation, cardiology, neurosciences, oncology, surgical innovation, infectious diseases and genomic medicine. Providing care to the community for more than two centuries, UHN brings together the talent and resources needed to achieve global impact and provide exemplary patient care, research and education.

For additional information, visit www.VistaGen.com

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Recently, when Bristol-Myers Squibb was forced to suspend testing of its pill for hepatitis C because one of the patients suffered heart failure, it was a major blow to the pharmaceutical giant. Bristol had spent more than a billion dollars in their search for a hepatitis C treatment, and they thought they had it with a nucleotide from an earlier acquired company called Inhibitex. The potential market is enormous for an effective remedy that is easier to administer than current hepatitis C treatments, with possible sales estimated to be well over a billion dollars. Bristol had paid $2.5 billion in cash for Inhibitex, and was in the process of performing safety tests for the drug when the heart failed in one of the test subjects. Adding to the problem was the fact that it was not even clear if the drug had actually caused the failure. In any event, Bristol-Myers was left with a lot less money and now no clear direction regarding the future of their very expensive drug.

The financial disaster was an example of exactly the type of costly mistake that VistaGen believes it can help pharmaceutical companies like Bristol-Myers avoid. VistaGen has spent years developing stem cell technology-based bioassay systems to help drug developers find out early on whether their drug candidates face a potential problem with heart or liver toxicity.

The company’s platform, called Human Clinical Trials in a Test Tube, is based upon a combination of proprietary and exclusively licensed stem cell technologies. These technologies enable controlled differentiation, or development, of pluripotent stem cells into mature human cells specific to the company’s predictive toxicology, drug metabolism, drug rescue, and cell therapy interests. In effect, it’s like having a human heart or liver in a test tube, allowing a close analysis of drug/tissue interaction at the earliest stages of development, and opening the possibility of drug rescue to leverage millions already spent by pharmaceutical companies to discover potential clinical benefits of new drug candidates put on the shelf due to heart or liver safety concerns. The potential savings all of this represents to the pharmaceutical industry is immense.

For additional information, visit www.VistaGen.com

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VistaGen Therapeutics, a biotechnology company applying stem cell technology for drug rescue, predictive toxicology, and drug metabolism screening, today announced a significant advance in its development of LiverSafe 3D™, a human liver cell-based bioassay system designed to predict liver toxicity and drug metabolism issues in connection with the company’s drug rescue activities.

Shawn K. Singh, VistaGen’s Chief Executive Officer, stated, “As we have done with CardioSafe 3D™, our stem cell-based bioassay system for predictive heart toxicity screening and drug rescue, we are developing LiverSafe 3D™ to change the game in drug development — to generate clinically predictive liver toxicology and liver metabolism data at the front end of the drug development process, long before standard animal and human testing.”

VistaGen’s LiverSafe 3D™, together with optimized culture protocols and without the need for any purification, can now produce differentiated populations of cells containing greater than 70% albumin-positive human hepatocytes (liver cells), and greater than 40% of these hepatocytes express the mature CYP3A4 drug metabolizing enzyme. CYP3A4 is a crucial enzyme in adult liver functions and widely viewed as an important functional marker for adult stem cell-derived hepatocytes. This enzyme is responsible for metabolizing over 50% of the drugs approved by the FDA. With purification, LiverSafe 3D™ can obtain hepatocyte populations approaching 90% expressing the CYP3A4 enzyme.

H. Ralph Snodgrass, PhD, VistaGen’s President and Chief Scientific Officer, commented, “Our LiverSafe 3D™ bioassay system involves custom-designed liver cells that are engineered to indicate when CYP3A4 is produced, and to allow the selection for mature cells expressing CYP3A4. On a per cell basis, LiverSafe 3D™ hepatocytes express functional CYP3A4 drug metabolism activity that approaches 25% to 40% of the metabolic activity seen with some commercial batches of human hepatocytes. We believe that this frequency and activity far exceed most, if not all, comparable data reported in the literature for stem cell-derived human hepatocytes. Our continuing R&D efforts are focused on further improvements of LiverSafe 3D™ to the point where it is comparable in all aspects to commercial human liver cells.”

Primary human cadaveric hepatocytes are well established, and, in many cases, are required by the FDA as an in vitro drug development tool for predicting liver toxicity, drug metabolism, and drug-drug interactions. However, the demand for primary human cadaveric hepatocytes for these studies exceeds the available supply. Even ignoring the supply limitations and high costs, primary human cadaveric hepatocytes have several undesirable attributes for drug development applications, including (1) the health of the donor and quality of the cadaveric hepatocytes received in the laboratory are often not ideal, (2) even high quality cadaveric hepatocytes rapidly lose critical hepatocyte functions important to drug development, and (3) batches of human cadaveric hepatocytes exhibit unknown and uncontrolled genetic variations that can dramatically influence the outcome of drug responses and metabolism. These, and other limitations of primary human cadaveric hepatocytes, highlight a widespread understanding of the pharmaceutical industry’s need for a clinically predictive and readily accessible alternative for drug development. VistaGen is developing LiverSafe 3D™ to meet that need.

For more information on VistaGen and its Human Clinical Trials in a Test Tube™ platform, visit www.vistagen.com

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The idea of a turnaround is often associated with dysfunctional companies being purchased by outsiders or otherwise given new management, and then being transformed with a change in product, structure, or philosophy, providing a fresh and profitable direction for what had been a losing asset. If coming from the outside, the process can be extremely lucrative, allowing a purchase or major stake at bargain basement prices, and then rapidly growing that investment through the application of proven principles. Individuals and companies who have taught themselves how to identify and resolve corporate weaknesses stand to profit handsomely once they have the resources to get in on the action.

VistaGen Therapeutics seeks to apply the turnaround concept in a creative new way that could end up turning millions and perhaps billions of dollars in lost pharmaceutical development into positive revenue. Using their proprietary stem cell technology, VistaGen has been able to develop a revolutionary bioassay platform that allows drug developers to accurately test for things like heart toxicity right in the laboratory, prior to lengthy clinical testing and well before going to the huge expense and risk of taking a drug to market. Such early in-lab testing allows developers to carefully guide the initial formulation of drug candidates, providing an effective new way to develop drugs and even rescue previously shelved drug candidates.

VistaGen’s stated goal is to use their advanced stem cell technology to build a diverse drug pipeline consisting of new, proprietary small molecule “drug rescue variants” which are as effective as once promising drug candidates but without the heart or liver toxicity that caused them to be put on the shelf. They are, in effect, looking to identify and then turn around approaches that had been considered largely lost. They believe each lead drug rescue variant will have the potential to be a new drug candidate in which they plan to have economic participation rights (up front and development milestone payments and royalties on commercial sales).

Considering that it can easily take on average investment of $800 million to $1.7 billion, plus 12 to 15 years, before a new drug candidate reaches the market, all of which can be lost due to unexpected and often late-discovered heart or liver toxicity problems, the value of a novel in vitro technology, a Clinical Trial in a Test Tube™, that can help rescue part or the entirety of that large investment is clear.

For additional information, visit www.VistaGen.com

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