Archive for the ‘VistaGen Therapeutics Inc. VSTA’ Category

VistaGen Therapeutics, Inc. (VSTA) Receives Notice of Allowance for U.S. Patent Expanding Stem Cell Technology Platform for Drug Rescue and Regenerative Medicine

Wednesday, April 23rd, 2014

Today, VistaGen Therapeutics announced that it has received broader intellectual property protection for its stem cell technology platform. The United States Patent and Trademark Office recently issued a notice of allowance (NOA) for U.S. Patent Application 12/836,275, entitled “Cell populations enriched for endoderm cells.” The NOA extends VistaGen Therapeutics’ intellectual property portfolio for pluripotent stem cell culture systems that produce human cells of the endoderm lineage, including liver, lung, pancreas, parathyroid, and thyroid cells.

When issued, this patent will be complementary to U.S. Patent Nos. 7,763,466, 8,512,957 and 8,143,009, both of which are exclusively licensed by VistaGen Therapeutics from the Ichan School of Medicine at Mount Sinai in New York.

“This patent allowance is another critical step in extending intellectual property protection for our stem cell technology platform. LiverSafe 3D™, one of our core assay systems for drug rescue, in particular stands to benefit greatly from this broader intellectual property protection,” stated Shawn K. Singh, VistaGen’s Chief Executive Officer.

“In addition to expanding the scope of our drug rescue opportunities, this patent allowance and our world-class differentiation expertise put VistaGen in a unique position to pursue potential stem cell research collaborations related to liver biology and drug metabolism assays, as well as pancreatic beta-islet cells for drug and regenerative cell therapy for diabetes,” said Ralph Snodgrass, Ph.D., VistaGen’s President and Chief Scientific Officer.

VistaGen Therapeutics’ reception of the NOA builds on other recent developments that could be promising for the company. VistaGen Therapeutics recently joined the Cardiac Research Safety Consortium, a driving force in public-private research that evaluates the cardiac safety of medical products. The Cardiac Research Safety Consortium draws upon expertise from key stakeholders in the industrial, academic, and governmental sectors for data sharing and expertise. It was launched as a public-private partnership in 2006 through an FDA Critical Path Initiative Memorandum of Understanding with Duke University. With this new membership, VistaGen Therapeutics can benefit from new, key partnerships in the future.

The company’s LiverSafe 3D™ technology is a human liver cell-based biological assay system capable of predicting liver toxicity and metabolism issues in drug candidates that have been stop-gapped for development due to any unexpected liver problems arising during development. This technology is complemented by VistaGen Therapeutics’ other technology, CardioSafe 3D™, another biological assay that is useful in predicting in vivo cardiac effects, both toxic and nontoxic, of promising new drug candidates long before they are tested in humans.

More information about VistaGen Therapeutics, its developments, and its potentially revolutionary innovations for the biotechnological space can be found at www.vistagen.com.

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VistaGen Therapeutics, Inc. (VSTA) Stem Cell Expertise Brings New Life to Discarded Drug Candidates

Tuesday, April 22nd, 2014

VistaGen Therapeutics is a San Francisco-based biotechnology company that focuses on human stem cell technology for the purposes of drug rescue, predictive toxicology, and drug metabolism screening. The company was founded in 1998 and has spent the last 16 years establishing its reputation as an expert in human pluripotent stem cell (hPSC) technology.

VistaGen Therapeutics’ drug rescue efforts involve combining its hPSC technology with the most up-to-date medicinal chemistry to generate new chemical variants of drug candidates that were abandoned by biotechnology or pharmaceutical companies before the market approval stage.

The drug candidates in which VistaGen is interested include those that were abandoned because of concerns about their effect on the heart and liver. VistaGen believes it can work with these discontinued drug candidates to cost effectively generate new, proprietary variants with reduced toxicity. The company’s end goal is to generate a pipeline of Drug Rescue Variants™ and sell them to biotechnology and pharmaceutical companies so that they can be further developed, approved, and sold commercially.

VistaGen Therapeutics is accomplishing its goals through the use of its hPSC technology platform, called Human Clinical Trials in a Test Tube™. The technology allows VistaGen to assess the Drug Rescue Variants’ heart and liver safety profiles.

Though there are other technologies like this on the market, Human Clinical Trials in a Test Tube™ is unique because it allows VistaGen to perform this task with greater speed and precision than conventional testing technology. Often times, companies spend decades and millions of dollars in drug candidates that only result in failure. VistaGen’s model is designed to leverage third-party investments, speed up the testing process, and recycle candidates that may have only been a few steps shy of being successful.

VistaGen’s research initiatives extend beyond its laboratories. In April 2014, the company announced that it became a member of the Cardiac Safety Research Consortium, an organization that supports research into the evaluation of cardiac safety of medical products. VistaGen is committed to staying at the cutting edge of cardiac safety, given that it is the lynchpin for the success of its proprietary drug candidates.

For more information, please visit www.vistagen.com

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VistaGen Therapeutics, Inc. (VSTA) Commercial Drug Rescue Potential Underwritten by Stem Cell Bioassay’s Cardiac Drug Safety Benchmarking

Monday, April 14th, 2014

VistaGen’s human pluripotent stem cell (hPSC) based approach to salvaging the massive outlays that are otherwise eaten when a once-promising drug candidate is dropped due to unexpected heart or liver toxicity complications (or preemptively preventing such losses), using their proprietary Human Clinical Trials in a Test Tube™ platform to accurately model the effects and develop safer Drug Rescue Variants™, also happens to be extremely useful for modeling non-toxic effects and thus represents a framework technology for drug development unlike anything which has come before it. The core component of this platform, an in-vitro bioassay system that utilizes functional/mature human heart cells derived from hPSCs to create three dimensional cardiac tissues, known as CardioSafe 3D™, is designed to be vastly more precise and expedient than extant surrogate safety models.

VistaGen recently reported (Apr 10) some big news in this area that will no doubt lead to key partnerings in future, as the company has become a member of the renowned public-private medical product cardiac safety research organization, the Cardiac Safety Research Consortium (CSRC), which was created back in 2006 via the FDA’s Critical Path Initiative MoU with Duke University. Since inception, the CSRC has come to be known as a driving force in public health and cardiac safety among the wide range of academic, governmental, and industrial stakeholders in the biopharma space which it engages in the support of these ends.

President of VSTA and the company’s CSO, Ralph Snodgrass, Ph.D., underscored the significance of mounting cardiac safety concerns associated with new drug candidates and the importance of identifying complications prior to human studies, further emphasizing that these concerns are the very internal mechanism which drives VSTA itself. Snodgrass also pointed to the key area of proarrhythmia safety, a serious and not infrequent complication in antiarrhythmic drugs where they actually provoke new arrhythmia (or a marked spike in the frequency of a preexisting arrhythmia), as being a primary target. Professor of Medicine at Duke and CSRC Co-Chair, Mitchell Krucoff, MD, FACC, hailed the start of a long and productive relationship with VSTA, noting the company’s commitment to proactive cardiac safety and how their membership strengthens the CSRC as well.

VSTA has winning technology here, with their ability to create a 3D bioassay that can be used to rapidly assess and benchmark new drugs, offering levels of detail and accuracy that make existing animal models or mere in-vitro cell culture approaches look like the antiquated technologies that they really are. The long-term potential for VSTA to prove up Drug Rescue Variants is enhanced by being able to make strategic connections through the CSRC membership and this relationship will help throw a spotlight on the compelling advantages of the company’s technology for predictive toxicology and drug metabolism assays, in addition to drug rescue.

Alongside CardioSafe 3D™, VSTA has developed a second major Human Clinical Trials in a Test Tube component, LiverSafe 3D™, designed to test drug-drug interactions and provide the same kind of over-the-horizon radar system for liver toxicology. In light of prior CardioSafe 3D™ developments regarding its use as a clinically predictive system for assessing cardiac toxicity in anti-cancer drugs, especially the revolutionary new small molecule kinase inhibitors which have drawn criticism (despite other benefits) for causing cardiac events not detected during drug development, this latest news about the CSRC membership is very bullish for VSTA and investors should keep an eye on the company as the broader biotech sector trims.

More info on this pioneering biotech developer is available at www.vistagen.com

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VistaGen Therapeutics, Inc. (VSTA) Joins the Cardiac Research Safety Consortium

Thursday, April 10th, 2014

Today, VistaGen Therapeutics announced its membership in the Cardiac Research Safety Consortium, a public-private partnership launched in 2006 through an FDA Critical Path Initiative Memorandum of Understanding with Duke University. The consortium aims to support research efforts that evaluate the cardiac safety of medical products, drawing upon input from stakeholders from across industrial, academic, and governmental sectors for data sharing and expertise.

VistaGen Therapeutics is the creator of CardioSafe 3D™, a novel in vitro bioassay system capable of predicting the cardiac effects, both toxic and non-toxic, of small molecule drug candidates with greater speed and precision than alternative, often-used safety models in drug development. That is inclusive of animal models and cellular assays that use primary, immortalized, or transformed cells. VistaGen Therapeutics incorporates use of mature, functional heart cells differentiated from human pluripotent stem cells for its revolutionary in vitro bioassay system.

The company’s CardioSafe 3D™is the central component of the company’s groundbreaking stem cell technology platform, Human Clinical Trials in a Test Tube™. With its ability to detect unexpected heart and liver safety issues in drug candidates, the stem cell technology is said to have tremendous potential for remedying widespread drug discovery and development crises within the U.S. pharmaceutical industry. VistaGen Therapeutics will be extending its expertise in cardiac safety for advancement of research efforts in the consortium.

“We look forward to partnering with the pharmaceutical, biotechnology, academic, and regulatory members of the Cardiac Safety Research Consortium, and contributing our expertise to support rapid advancement of our understanding of cardiac safety. Cardiac safety, especially identifying proarrhythmic safety concerns of new drug candidates prior to human studies, drives our internal efforts every day, and we welcome the opportunity to participate in this innovative process with the consortium,” said Ralph Snodgrass, Ph.D., VistaGen’s President and Chief Scientific Officer.

“VistaGen shares our commitment to improving cardiac safety of new medical products, and its membership will strengthen CSRC,” commented Mitchell W. Krucoff, MD, FACC, Professor of Medicine at Duke University and CSRC Co-Chairperson. “We look forward to a productive, long-term relationship with VistaGen.”

For more information about VistaGen Therapeutics and its biotechnological initiatives, please visit: www.vistagen.com

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VistaGen Therapeutics, Inc. (VSTA) Strategy Offers Foresight in Drug Candidate Approval Process

Tuesday, April 1st, 2014

VistaGen Therapeutics believes the U.S. pharmaceutical industry is facing a drug discovery and development crisis. In 2012, the U.S. pharmaceutical industry invested over $48 billion in research and development. As a result the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) approved a total of 39 novel drugs, known as New Molecular Entities (NMEs). In 2013, the FDA approved 27 NMEs.

Despite the aforementioned monumental investment by the pharmaceutical industry, since 2003, the FDA has approved an average of 26 NMEs per year. VSTA believes the high cost of drug development and relatively low annual total of FDA-approved NMEs are attributable in large part to the cost of failure associated with unexpected heart and liver safety issues. In turn, the company believes unexpected heart and liver safety issues often result from limitations of the major toxicological testing systems used in the pharmaceutical industry, namely animals and cellular assays based on transformed cell and immortalized cell lines and explanted primary cells, including human cadaver cells.

After spending millions of dollars over nearly a decade to discover, optimize, and validate the potential efficacy of a promising new drug candidate and subsequently move it into preclinical development, a biotechnology or pharmaceutical company can see their drug candidate fail to progress due to unexpected heart or liver safety issues. The company then often discontinues the program for their once-promising drug candidate and indefinitely pause developmental progress despite the positive data that shows potential therapeutic and commercial benefits. As a result, the company’s significant prior investment in discovery and development may be lost.

VistaGen is in the business of believing that using human heart and liver cells can make better toxicological testing systems and better drug candidates. The company believes that the human heart and liver cells they make, and the toxicological testing systems in which they use them, can transform drug development in the pharmaceutical industry. It is estimated that about one-third of all potential new drugs candidates fail in preclinical or clinical development due to unexpected safety concerns.

For more information visit www.vistagen.com

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VistaGen Therapeutics, Inc. (VSTA) Impressive in Predicting Test Outcomes of Vital Drug Candidates

Thursday, March 27th, 2014

VistaGen Therapeutics is keenly aware that despite decades of well-intentioned awareness and prevention campaigns, heart disease is still the leading cause of death for both men and women. The disease kills more than 600,000 Americans each year. According to the Center for Disease Control, approximately 49 percent of Americans have at least one of the three risk factors for heart disease – these being high blood pressure, high LDL cholesterol, and smoking. Despite researcher insights concluding that an overwhelming majority of heart disease is the result of poor lifestyle choices, scientists understand the statistics are dynamic in nature and must be constantly monitored.

VistaGen is a life sciences company that innovatively leverages its Human Clinical Trials in a Test Tube™ technology platform to provide clinically relevant predictions of potential toxicity of promising new drug candidates. Cardiovascular care is one of VistaGen’s particular areas of focus.

Unexpected safety concerns are pointed to as the reason why about one-third of all potential new drug candidates fail in preclinical or clinical development. It is believed that many lives could have been saved if it were not for promising cardiovascular drugs being discontinued because of late-stage failure. Using human heart cells derived from human pluripotent stem cells (hPSCs), VistaGen’s technology is designed to address potential toxicity of new cardiovascular drug candidates long before they are ever tested in humans.

CardioSafe 3D™, the company’s novel three-dimensional (3D) bioassay system, was developed to identify safer drug rescue variants with reduced heart safety concerns, which can be missed in animal models or in vitro cell culture testing currently used by biotechnology and pharmaceutical companies.

VistaGen’s plan is to combine CardioSafe 3D™ with modern medicinal chemistry to build a pipeline of safer chemical variants (Drug Rescue Variants™) of once-promising drug candidates that initially were developed by biotechnology and pharmaceutical companies, but were abandoned later due to the concerns mentioned earlier. Other notable work involves AV-101, the company’s lead small molecule drug candidate. The drug has successfully completed Phase I development in the U.S. for treatment of neuropathic pain, a serious and chronic condition causing pain after an injury or disease of the peripheral or central nervous system. Neuropathic pain affects millions of people worldwide. VSTA believes its Phase 1 safety program will enable Phase 2 development of AV-101 for neuropathic pain, depression, and potentially other neurological conditions. To date, VistaGen has been awarded over $8.8 million from the NIH for development of AV-101.

The core goal is to license or sell Drug Rescue Variants to biotechnology and pharmaceutical companies for further development and commercialization. VistaGen believes its strategy has the potential to substantially reduce drug development costs and produce effective and safer drugs, which would inherently help save human lives.

For more information visit www.vistagen.com

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VistaGen Therapeutics, Inc. (VSTA) Targeting Nation’s No. 1 Killer with Proprietary 3D Bioassay System

Wednesday, March 19th, 2014

Despite decades of awareness and prevention campaigns, heart disease remains the No. 1 cause of death for both men and women, killing more than 600,000 Americans each year. Roughly 49 percent of Americans have at least one of the three risk factors for heart disease: high blood pressure, high LDL cholesterol and smoking, according to the Center for Disease Control. What’s astounding is that an overwhelming majority of heart disease is the result of poor lifestyle choices. While it’s certainly nothing to celebrate, the statistics are keeping scientists on their toes and companies like VistaGen in business.

VistaGen is an innovative life sciences company leveraging its Human Clinical Trials in a Test Tube™ technology platform to provide clinically relevant predictions of potential toxicity of promising new drug candidates. One of VistaGen’s particular areas of focus is on cardiovascular care.

It is estimated that about one-third of all potential new drugs candidates fail in preclinical or clinical development due to unexpected safety concerns. Countless human lives have been lost because “promising” cardiovascular drugs were discontinued because of late-stage failure. Using human heart cells derived from human pluripotent stem cells (hPSCs), VistaGen’s technology is designed to address potential toxicity of new cardiovascular drug candidates long before they are ever tested in humans.

CardioSafe 3D™, the company’s novel three-dimensional (3D) bioassay system, was developed to identify safer drug rescue variants with reduced heart safety concerns, which can be missed in animal models or in vitro cell culture testing currently used by biotechnology and pharmaceutical companies.

VistaGen’s strategy is to pair CardioSafe 3D™ with modern medicinal chemistry to build a pipeline of novel, safer chemical variants (Drug Rescue Variants™) of once-promising drug candidates that initially were developed by biotechnology and pharmaceutical companies, but that were later abandoned due to the aforementioned concerns.

The core goal is to license or sell Drug Rescue Variants to biotechnology and pharmaceutical companies for further development and commercialization. VistaGen believes its strategy has the potential to substantially reduce drug development costs and produce effective and safer drugs, which would inherently help save human lives.

For more information visit www.vistagen.com

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VistaGen Therapeutics, Inc. (VSTA) Poised to Revolutionize Clinical Trials and Pioneer hPSC Technology for Drug Rescue

Friday, March 14th, 2014

Biotechnology company VistaGen Therapeutics is blazing trails with advances in pluripotent stem cell technology, operating on the belief that “Better Cells Make Better Medicine.”

Human Clinical Trials in a Test Tube is the company’s versatile human pluripotent stem cell (hPSC) technology platform, which has been developed to give clinically relevant predictions of the potential toxicity of promising new drug candidates long before they ever reach the human testing stage. VistaGen’s hPSC-based bioassay systems much more closely approximate human biology than the conventional animal testing and other nonclinical techniques and technologies currently being used in drug development.

VistaGen has expertise in applying hPSC technology for drug rescue, which includes predictive toxicology and drug metabolism screening. Through drug rescue, a combination of hPSC technology and medicinal chemistry is used to create new proprietary chemical variants, or Drug Rescue Variants, of small-molecule drug candidates that were once promising but were, after discovery and development, ultimately discontinued by biotechnology or pharmaceutical companies due to unexpected heart or liver safety concerns before they achieved market approval.

VistaGen believes Human Clinical Trials in a Test Tube enables heart and liver safety assessment of Drug Rescue Variants and other new drug candidates with greater speed and precision than currently used nonclinical drug development testing and technologies.

VistaGen’s primary aim is to generate a pipeline of Drug Rescue Variants and then license or sell them to biotechnology and pharmaceutical companies for further development and, ultimately, commercialization.

Currently, a significant stumbling block in the drug development process is the fact that conventional nonclinical surrogate safety models, such as live animal models, altered animal cells, immortalized and transformed cells, and explanted primary cells, can, at most, only approximate human biology in supporting important drug development decisions. Discontinuation due to unexpected heart or liver concerns means years of work and tens of millions of dollars can be lost after a biotechnology or pharmaceutical company attempts to discover, optimize, and validate a promising lead drug candidate’s potential efficacy and to advance its development. With VistaGen’s drug rescue model, however, substantial previous third-party discovery and development investments for once-promising drug candidates can be leveraged, along with the clinically predictive drug development capabilities of Human Clinical Trials in Test Tube™, to generate and assess key components of the heart and liver safety profiles of Drug Rescue Variants.

Parallel with its drug rescue activities, VistaGen intends to explore pilot nonclinical development opportunities related to regenerative cell therapy, with an emphasis on blood, heart, liver, and pancreas cells derived from hPSCs.

The company has successfully completed Phase 1 development of AV-101 with grant funding from the U.S. National Institutes of Health (NIH). AV-101 is an orally available small-molecule pro-drug candidate that is targeted at the multibillion-dollar neurological disease and disorders market, which includes neuropathic pain. VistaGen received more than $8.8 million in grant funding from the NIH to support its nonclinical and Phase I clinical development of AV-101.

For more information, visit: www.vistagen.com

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VistaGen Therapeutics, Inc. (VSTA): Human Clinical Trials in a Test Tube™ to Curb Cost and Time to Market

Monday, March 3rd, 2014

VistaGen Therapeutics, a California-based biotechnology company, is addressing the need to bring effective treatments to market while reducing the time and cost traditionally needed to do so. By leveraging its Human Clinical Trials in a Test Tube™, the company is using human pluripotent stem cell technology to enable biotechnology and pharmaceutical companies to identify unexpected heart or liver safety concerns before a drug candidate has journeyed far into its development process. With this “drug rescue” capability, biotechnology and pharmaceutical companies also become able to renew their approval efforts of once promising, but currently idle drug candidates that were discontinued due to heart or liver safety issues.

In a recent editorial by the Washington Post on new drug development initiatives by the National Institutes of Health, the cost of drug development failure is daunting and pervasive within the industry. According to the editorial, “taking a drug candidate from early discovery through Food and Drug Administration approval takes a decade and has a 95 percent failure rate.” Plus, with the cost of drug development being known to be able to exceed $1 billion, it is clear that pharmaceutical companies face a very uphill challenge in bringing blockbuster, high-therapeutic-potential drugs to market in today’s “drug approval climate.”

In a Forbes article from 2012 it states the financial risk associated with a failed drug candidate for a big pharmaceutical company can be huge. The article notes that the cost of an average drug developed by a major pharmaceutical company is at least $4 billion. It’s in these environments where the drug rescue potential of VistaGen Therapeutics’ technology becomes clear. VistaGen Therapeutics believes that conventionally used toxicological testing systems, such as animal testing and other nonclinical methods, do not closely approximate human biology enough to account for initially undetected liver and heart toxicity and metabolism issues. Human Clinical Trials in a Test Tube™, in contrast, enables the differentiation of human pluripotent stem cells into mature human cells. With these resources in hand, therapeutic solution developers are then able to attempt identification of any emerging liver or heart safety issues before a drug candidate has generated huge costs in research and development.

Mr. Shawn Singh, J.D., Chief Executive Officer of VistaGen Therapeutics, has described the disruptive potential of Human Clinical Trials in a Test Tube™ as “game-changing.” Having noted that he has not seen anything like the ways VistaGen Therapeutics is applying stem cell technology in his broad professional career, Mr. Singh has acknowledged his confidence that the human pluripotent stem cell technology could change the face—and cost dynamics—of American drug development and approval.

For more information, visit: www.vistagen.com

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VistaGen Therapeutics, Inc. (VSTA) Tackling Expensive Problem of Drug Failure with Human Clinical Trials in a Test Tube™

Tuesday, February 25th, 2014

With diseases such as Alzheimer’s, type 2 diabetes, and rheumatoid arthritis on the rise, there is a growing need for new and more effective treatments. But as an editorial by the Washington Post on new drug development initiatives by the National Institutes of Health makes clear, the cost of drug development failure is staggering—and widespread. According to the editorial, “taking a drug candidate from early discovery through Food and Drug Administration approval takes a decade and has a 95 percent failure rate.” Plus, with the cost of drug development being known to be able to exceed $1 billion, it is clear that pharmaceutical companies face a very uphill challenge in bringing blockbuster, high-therapeutic-potential drugs to market in today’s “drug approval climate”.

VistaGen Therapeutics, a California-based biotechnology company, meets this problem head-on with its Human Clinical Trials in a Test Tube™, a human pluripotent stem cell technology that enables biotechnology and pharmaceutical companies to identify unexpected heart or liver safety concerns before a drug candidate has journeyed far into its development process. With this “drug rescue” capability, biotechnology and pharmaceutical companies also become able to renew their bring-to-approval efforts of once-promising-but-now-backshelved drug candidates that were discontinued due to heart or liver safety issues.

According to a Forbes article in 2012, the sunk cost of a failed drug candidate for a big pharmaceutical company can be huge. The article notes that the cost of an average drug developed by a major pharmaceutical company is at least $4 billion. That is where the drug rescue potential of VistaGen Therapeutics’ technology becomes clear. VistaGen Therapeutics believes that conventionally used toxicological testing systems, such as animal testing and other nonclinical methods, do not closely approximate human biology enough to account for initially undetected liver and heart toxicity and metabolism issues. Human Clinical Trials in a Test Tube™, in contrast, enables the differentiation of human pluripotent stem cells into mature human cells. With these resources in hand, therapeutic solution developers then become able to identify any emerging liver or heart safety issues before a drug candidate has generated huge sunk costs in research and development.

Mr. Shawn Singh, J.D., Chief Executive Officer of VistaGen Therapeutics, has described the disruptive potential of Human Clinical Trials in a Test Tube™ as “game-changing”. Having noted that he has not seen anything like the ways VistaGen Therapeutics is applying stem cell technology in his broad professional career, Mr. Singh has signified his confidence that the human pluripotent stem cell technology could change the face—and cost dynamics—of American drug development and approval.

For more information, visit: www.vistagen.com

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How Big Pharma Stands to Benefit from VistaGen Therapeutics’ (VSTA) Human Clinical Trials in a Test Tube™ Platform

Tuesday, February 18th, 2014

The U.S. Food and Drug Administration has a low tolerance for drug candidates with safety risks; countless potential new drugs candidates fail in preclinical or clinical trials due to safety concerns, costing pharmaceutical companies billions of dollars in research and development (R&D) costs. VistaGen Therapeutics, a biotech company applying stem cell technology for drug rescue and cell therapy, believes that the majority of pricey and unexpected heart and liver toxicity and metabolism issues is due to limitations of the major toxicological testing systems currently used in the pharmaceutical industry, such as animal testing and cellular assays based on transformed cell lines and human cadaver cells.

VistaGen has developed the Human Clinical Trials in a Test Tube™ to address this problem. The platform takes human pluripotent stem cells, cells that have the ability to be geared and developed into any other kind of cell in the human body, and differentiates them into useable human heart cells and human liver cells. The company’s goal is to pair its stem cell technology with modern medicinal chemistry to create a diverse drug pipeline consisting of new, proprietary, small molecule variants (drug rescue variants) of once-promising drug candidates.

Upon developmental success, each lead drug rescue variant has potential to be a new drug candidate through which VistaGen can have upfront and development milestone payments and royalties on commercial sales. For big pharma companies struggling to roll-out new drugs, VistaGen’s technology offers an incredible solution.

Take Pfizer, for example. The company cut its R&D costs by $800 million to $6.6 billion last year to offset lagging revenues. In a recent article published on FierceBiotech.com, author John Carroll writes that while Pfizer expects to spend between $6.4 billion – $6.9 million on this year’s R&D, there’s speculation the company is capable of developing new blockbuster products. In 2013, Pfizer received FDA approval for Duavee, for hot flashes caused by menopause. Carroll also notes while the company received numerous FDA approvals in 2012, revenues continued to disappoint.

In conclusion, Carroll writes of Pfizer, “… there’s no convincing sign that the pharma giant has figured out how to get more out of the multibillion-dollar research budget that remains.”

According to the Food and Drug Administration even only a 10 percent improvement in predicting failure before clinical trials could save $100 million in development costs, which for a company in Pfizer’s position would allow for maximum use of R&D funds before digging too deep into the budget. VistaGen’s Human Clinical Trials in a Test Tube™ has been developed to provide clinically relevant predictions of potential heart and liver toxicity of promising new drug candidates long before they are ever tested on humans.

By more closely approximating human biology than conventional animal studies and other nonclinical techniques and technologies currently used in drug development, VistaGen’s human stem cell-based bioassay systems can improve the predictability of the drug development cycle and lower the cost of new drug research and development by identifying product failures earlier in the cost curve.

For more information, visit www.vistagen.com

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VistaGen Therapeutics, Inc. (VSTA) Highlights Drug Rescue Potential at Noble Financial Capital Markets’ 9th Annual Equity Conference

Tuesday, February 11th, 2014

VistaGen Therapeutics is a California-based biotechnology company that specializes in the application of human pluripotent stem cell (hPSC) technology for drug rescue, including predictive toxicology and drug metabolism screening. The company’s hPSC technology platform, Human Clinical Trials in a Test Tube™, enables accessibility to the heart and liver safety profile of drug rescue variants and other new drug candidates with greater speed and precision than conventional nonclinical testing and technologies used in drug development. Harnessing this technology’s unique power, VistaGen Therapeutics enables “drug rescue” of once-promising-but-now-backshelved drug candidates that have been discontinued by biotechnology or pharmaceutical companies prior to market approval due to unexpected heart or liver safety concerns.

Recently, the company made an appearance at Noble Financial Capital Markets’ 9th Annual Equity Conference. The conference took place Wednesday, January 22, 2014 to Thursday, January 23, 2014 at the Seminole Hard Rock Hotel in Hollywood, Florida. There, some 100 publicly held companies’ corporate representatives showcased their companies’ profiles, business strategies, and outlooks. Investment portfolio managers and equity analysts were on hand to analyze the representatives’ presentations, ask questions, and get a good all-around sense of how each business offers growth potential.

At the event, Mr. Shawn K. Singh, J.D., Chief Executive Officer of VistaGen Therapeutics, said that VistaGen Therapeutics is “changing the game” in the area of stem cell technology. Noting his experience of 22 years in the biotech space, Mr. Singh noted that 2014 will be the “breakout year” for the company.

Having touched upon his executive experience, he then said that the company is “applying stem cell technology in ways [he] has not seen possible in the last couple of decades in this space.” According to a Forbes article from February 2012, the sunk cost of drug development is huge, as the “average drug developed by a major pharmaceutical company costs at least $4 billion.” Likewise, the failure of drug development was noted to be staggering and largely attributable to heart or liver toxicity, with over 50% of drug development efforts failing due to these medical concerns.

Mr. Singh touched upon the efficacy of Human Clinical Trials in a Test Tube in combating these sunk cost risks, as the hPSC technology platform identifies failure potential early in a drug’s development process before too many cost have been paid. In short, the technology lets pharmaceutical companies “bring human biology to the forefront of drug development”, thereby letting them “change the game early” in their drug development stages. He then went on to discuss other key company focuses and goals for 2014.

The entirety of Mr. Singh’s presentation at the Noble conference can be found at: http://noble.mediasite.com/mediasite/Play/7b2df397209e4accad8b01e55857bb431d?catalog=7196f4ed-1981-4e62-afb2-e3a1f13bc7fb

For more information about VistaGen Therapeutics and its technologies, visit: http://www.vistagen.com

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VistaGen Therapeutics, Inc. (VSTA) Drug Rescue Program Aligned with Needs in Drug Approval Process

Tuesday, February 4th, 2014

In calendar year 2013, the U.S. FDA’s Center for Drug Evaluation and Research (CDER) approved 27 novel new medicines (NMEs) approved under New Drug Applications (NDAs) and Biologics License Applications (BLAs). This comes from a report from the FDA that also says submissions for novel new medicines in the last decade have been relatively flat, with the exception of 2012.

While all applications submitted in 2013 were not accepted for filing as of December 31, 2013, CDER forecasts that about 36 total applications were submitted for 2013, meaning nine were left on the table for one reason or another.

This information is of particular value to VistaGen Therapeutics, a small-cap biotech company focused on reviving once-promising drug candidates that were shelved due to toxicity issues. The expense of failure is staggering for the company and investors that have invested considerable time and money in their drug candidates. This high cost of failure associated with unexpected heart and liver toxicity and metabolism issues drives the cost to develop drug candidates higher and results in relatively low annual number of FDA-approved NMEs.

VistaGen believes that the majority of pricey and unexpected heart and liver toxicity and metabolism issues stem from limitations of the major toxicological testing systems currently used in the pharmaceutical industry, namely animal testing and cellular assays based on transformed cell lines and human cadaver cells.

The company’s solution is its Human Clinical Trials in a Test Tube™, which utilizes human pluripotent stem cells (hPSCs), cells that have the ability to be geared and developed into any other kind of cell in the human body, and differentiates them into useable human heart cells and human liver cells. VistaGen’s strategy is to apply this technology combined with medicinal chemistry to generate new, proprietary drug rescue variants of once-promising small molecule drug candidates that were discarded for safety concerns.

Using mature human heart cells produced from its stem cell technology, VistaGen has developed CardioSafe 3D™, a novel, three-dimensional (3D) bioassay system for predicting the in vivo cardiac effects, both toxic and non-toxic, of drug rescue variants and other small molecule drug candidates before they are tested in animals and humans. The company is further expanding its drug rescue capabilities by developing LiverSafe 3D™, a novel bioassay system using hPSC-derived human liver cells to assess potential liver toxicity and adverse drug-drug interactions in drug rescue variants and other new drug candidates early in development, before animal and human testing. Identifying toxicity issues early in the development process can save considerable research, money and other resources.

Of the 27 drugs recently approved by CEDR, at least two pertained to cardiac disease. VistaGen is well-positioned to take advantage of unmet needs in this niche market of the healthcare industry.

For more information on VistaGen visit www.vistagen.com

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VistaGen Therapeutics (VSTA) Stands to Benefit from Unprecedented, Long Overdue Shift in Pharmaceutical Industry

Tuesday, January 28th, 2014

There’s a pivotal shift taking place the pharmaceutical industry, one that bridges the gap between the company with an $80 billion market cap and heavy cash flow and the one with an $8 million market cap scraping the bottom of the barrel. That bridge is called public market, and by connecting the landmass (market space, in this case) of both companies, there is considerable and growing symmetry in the balance of power between the pharmaceutical giants and the little guys.

In an interesting article entitled, “The Big Guys Have Lost Their Iron Grip, and It’s All Good,” author Luke Timmerman likens big pharma’s relationship with the small biotech players to his seventh grade physical education teacher, who used his size and a “patented ‘pinch’” to drag students to his office for disciplining.

Noting that big pharma companies for the last decade have taken the upper hand at the bargaining table against small companies with high-potential new therapies, Timmerman writes:

“That’s no longer true. The little guy with a promising new drug candidate can walk away from a low-ball bid and go public now. The rising tide of the stock market has roughly doubled the group of companies that have the cash to buy innovative new drugs. …What it means, essentially, is that the little guy in biotech that develops most of the innovative products suddenly has options. … More people will now be encouraged to start new biotech companies, to invest in them, and they will be fairly rewarded when successful. It’s the healthiest environment for innovation that I’ve seen in years.”

Here’s what used to happen. Biotech companies painstakingly and expensively worked for years to advance their innovations from idea through the development to validating results in clinical trials and setting out in search of licensing deals or acquisition. Then, a big pharma would flag the potential of this drug candidate and low-ball a measly bid to the biotech company who didn’t have the power to negotiate or ask for more.

“Then along came the great biotech bull market of 2013. It was the second-biggest year on record for biotech IPOs, with 52 companies going public by my count. The Nasdaq Biotech Index rose 66 percent last year, compared with the broader Nasdaq Composite Index, which saw a 39 percent gain,” writes Timmerman.

With the numbers comes leverage, and mid-cap pharmaceutical companies have grown into positions of opportunity to compete in acquisition bidding wars against bigger industry players. Now, small biotechs are in a better position to play the field of interested bidders and negotiate higher upfront payments, and more profitable milestones.

Take small-cap biotech company VistaGen, for example. VistaGen is focused on advancing its stem cell technology for drug rescue with the goal of generating a pipeline of drug rescue variants that it plans to license or sell them to larger biotech and pharmaceutical companies who have the resources to further develop and commercialize the product.

VistaGen is addressing major challenges in the drug development process based on the patented and clinically predictive drug development capabilities of its Human Clinical Trials in a Test Tube™ platform. In today’s market, VistaGen has an incredible change, buoyed by several variables, to sell its drug rescue variants to a larger company that will be willing to shell out a fair price.

“Part of what’s driving the higher prices, of course, is simple supply and demand. There’s always a scarcity of great new drugs in the pipeline … Pharma companies are as hungry as ever, and desperate in some cases, to fill up their meager R&D pipelines. … The big guys should be able to pick up a steady stream of innovations they can purchase, at still-reasonable prices. A few (not more than a handful) of venture capital firms will refill their coffers. They, along with a few good entrepreneurs, will be encouraged to invest in more groundbreaking, platform type technologies …,” states Timmerman.

Thanks to increasing equilibrium of power between pharmaceutical behemoths and innovative small-cap plays, companies like VistaGen find themselves in an unprecedented position of power and opportunity.

Read Timmerman’s full article here: http://www.xconomy.com/national/2014/01/20/the-big-guys-have-lost-their-iron-grip-and-its-all-good

For more information, visit www.vistagen.com

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VistaGen Therapeutics, Inc. (VSTA) Vision for Stem Cell Technology Aligned with Broader Hopes for Cardiotoxicity

Friday, January 24th, 2014

The U.S. pharmaceutical industry is facing a “drug discovery and development crisis,” says small-cap biotech VistaGen Therapeutics, evidenced by the fact that while the pharmaceutical industry in 2012 invested nearly $49 billion in R&D, a total of only 39 novel drugs were approved by the FDA. The hang-up is on the costly price tag of drug development and non-approval due to safety concerns of the candidates.

In recognition of this crisis, a movement toward the use of stem cell technology to address these issues has begun. VistaGen is already on board, leveraging its human cells derived from its human pluripotent stem cell (hPSC) technology, which it considers superior to major toxicological testing systems that use animal cells and cellular assays based on transformed cell lines and human cadaver cells, which at best only approximate human biology. The company believes it can develop better medicine by using its technology to provide clinically relevant biological information about a new drug candidate early in the drug development process, before time and money are spent on clinical trials.

In July 2013, the U.S. Food and Drug Administration (FDA) led a meeting with the FDA-sponsored Cardiac Safety Research Consortium, and the Health and Environmental Sciences Institute (HESI) to plan and discuss an overhaul to incorporate various individual ion channel assays and electrophysiological tests of stem cell-derived cardiomycocytes to revolutionize cardiac safety.

“The key thing we’ve realized over the last few years working on stem cells is that they are very much a game changer, particularly in cardiotoxicity,” Nick Thomas, principal scientist in cell technologies at GE Healthcare in Cardiff, UK, told Kelly Rae Chi in a recent article in Nature Reviews.

As the FDA and its cohorts hammer out a schema to address toxicity concerns and the issues of the development of drug candidates, VistaGen continues to advance its technology portfolio. The company’s Human Clinical Trials in a Test Tube™, is based upon a combination of the company’s proprietary and exclusively licensed hPSC technologies. The platform assesses the toxicity and metabolism (drug-drug interaction) profile of new small molecule drug candidates applicable to a wide range of diseases and conditions. The platform is designed to work at an accelerated and more precise rate than non-clinical in vitro techniques and technologies currently used by biotechnology and pharmaceutical companies.

VistaGen’s CardioSafe 3D™ novel biological assay system uses mature human heart cells derived from hPSCs to screen for heart toxicity in connection with the company’s drug rescue activities. The company believes that CardioSafe 3D™ is stable, reproducible, and capable of generating data to allow more accurate in vitro prediction of the in vivo cardiac effects, both toxic and nontoxic, of promising new drug candidates long before they are tested in humans.

Furthermore, VistaGen believes the results of its internal validation studies indicate that CardioSafe 3D’s efficacy in identifying safer drug rescue variants with reduced heart safety concerns, which can be missed in animal models or in vitro cell culture testing currently used by biotechnology and pharmaceutical companies.

For more information visit www.vistagen.com

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VistaGen Therapeutics, Inc. (VSTA) Human Pluripotent Stem Cell Technology is the Backbone of Promising Development Strategy

Friday, January 17th, 2014

Human Clinical Trials in a Test Tube™ — sounds like something out of a science fiction movie, but as it turns out, this is science reality. VistaGen Therapeutics is the developer of this versatile human pluripotent stem cell (hPSC) technology platform. The hPSC-based bioassay systems more closely approximate human biology than conventional animal testing and other nonclinical techniques currently being used, providing a high-potential path of success to the company’s primary objective.

In line with its overarching goal to revive once-promising drug candidates (drug rescue variants) that were abandoned due to unexpected heart or liver safety concerns, VistaGen has used its hPSCs to develop CardioSafe 3D™. The bioassay system is used to predict the in vitro/in vivo cardiac effects of new drug candidates before they are tested on a human. VistaGen aims to combine CardioSafe with modern medicinal chemistry to build its pipeline of drug rescue variants.

hPSCs are also being used to develop LiverSafe 3D™ to assess potential liver toxicity and adverse drug-drug interactions among relative drug candidates. In addition, the company intends to advance pilot non-clinical development of regenerative cell therapy programs focused on blood, cartilage, heart, liver, and pancreas cells.

VistaGen’s lead small molecule drug candidate, AV-101, has successfully completed phase 1 development for the treatment of neuropathic pain, a serious and painful condition following injury or disease of the peripheral or central nervous system. Building on the success of the first clinical trial, the company believes the safety program will enable phase 2 development of AV-101 for neuropathic pain, depression, and other neurological conditions.

VistaGen believes that its Human Clinical Trials in a Test Tube™ will enable the company to assess the heart and liver safety profile of drug rescue variants and other new drug candidates with greater speed and precision than conventional nonclinical testing and technologies used in drug development, supporting its goal of creating a pipeline of variants that can be licensed or sold to biotech and pharmaceutical companies for further development and commercialization.

For more information visit www.vistagentherapeutics.com

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VistaGen Therapeutics, Inc. (VSTA) Stem Cell Technology Revitalizing Approval Potential for Promising Drug Candidates

Friday, January 10th, 2014

Each year, the U.S. pharmaceutical industry invests billions of dollars in research and development of novel drugs, but many drugs never reach the final stage of FDA approval. For the pharmaceutical companies engaging in the R&D efforts, that results in sunk costs of billions in investments, “wasted” decades of research and development efforts, and back-shelved drug candidates that might have been shown to have great therapeutic potential.

VistaGen Therapeutics, a biotechnology company, believes that many of these drug candidates’ failures are attributable to failure costs associated with unexpected heart and liver safety issues. Moreover, the heart and liver safety issues may be tied to scientific limitations placed upon drug safety testing by industry-standard toxicological testing systems, namely animals and cellular assays based on transformed cell lines and human cadaver cells.

A Forbes article by Bernard Munos highlights that 27 novel drugs obtained FDA approval this year, down from 37 drug approvals in 2012. Likewise, VistaGen Therapeutics notes that since 2003, the FDA has approved fewer than 26 new drugs per year. Industry statistics notably show that around one-third of all prospective drug candidates fail in preclinical or clinical development due to the rise of sudden, unexpected safety issues.

VistaGen Therapeutics leverages a proprietary stem cell technology, Human Clinical Trials in a Test Tube™, to make clinical predictions of the toxicities of new drug candidates possible long before they reach human testing. The company’s human pluripotent stem cell-based systems are better suited for human biology approximation than today’s industry-standard toxicological testing systems and other methods of testing in drug R&D.

The technologies behind Human Clinical Trials in a Test Tube™ allow for human pluripotent stem cells to be differentiated into mature human cells for VistaGen Therapeutics’ various cell therapy programs and market opportunities. By detecting human toxicity or metabolism earlier in testing than usual, the technology enables pharmaceutical companies to redirect or reconstitute their efforts without the steep price tag of lost time and money associated with later drug approval failure.

More information about VistaGen Therapeutics, its technology, and its progress can be found at: www.vistagen.com

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VistaGen Therapeutics, Inc. (VSTA) Business Strategy Centers on Cutting-Edge Stem Cell Technology

Thursday, December 19th, 2013

VistaGen Therapeutics employs the expertise of company co-founder and renowned Canadian stem cell scientist Dr. Gordon Keller, as well as co-founder, president, and chief scientific officer Dr. Ralph Snodgrass.

Human Clinical Trials in a Test Tube™, the company’s human pluripotent stem cell (hPSC) technology platform, was developed using a combination of proprietary and exclusively licensed hPSC technologies, including those originating from two decades of research by Drs. Keller and Snodgrass.

The platform’s underlying technologies enable controlled differentiation of hPSCs into mature human cells specific to VistaGen’s current and potential predictive toxicology, drug metabolism, drug rescue, and regenerative cell therapy programs and commercial programs.

Utilizing these technologies, VistaGen is currently developing CardioSafe 3D™, a novel biological assay system that uses mature human heart cells derived from hPSCs to screen for heart toxicity in connection with the company’s drug rescue activities; LiverSafe 3D™, for predicting liver toxicity and metabolism issues in connection with the company’s drug rescue activities; and AV-101, a novel, orally available prodrug candidate focused on the treatment of neuropathic pain, depression, and potentially other neurological conditions.

VistaGen’s overarching goal is to combine its hPSC technology with medicinal chemistry to generate new, proprietary, chemical variants of small molecule drug candidates that were shelved due to unexpected heart or liver safety concerns.

The company believes its Human Clinical Trials in a Test Tube™ platform enables a more rapid and precise safety profile of drug rescue variants, allowing the company to generate a pipeline of drug rescue variants that it will license or sell to biotechnology and pharmaceutical companies that can further develop the products and bring them to market.

For more information, visit www.vistagen.com

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VistaGen Therapeutics, Inc.’s (VSTA) AV-101 Named as Notable Contender in Race for Safe, Efficient Antidepressant Agent

Wednesday, December 11th, 2013

Antidepressants are the most commonly consumed class of therapeutics in the United States, prescribed to more than 270 million patients each year. Ketamine, an NMDA receptor antagonist used as an anesthetic in human and veterinary medicine, can also be effective in treating depression. The drug’s side effects, such as hallucinations or psychotic symptoms, however, have made it a widely used and dangerous recreational drug referred to as “Special K.”

The hallucinogenic and psychotic side effects hinder the interpretation of its clinical activity and limit its use as a therapeutic option for many patients. As the dangers of mental illness becomes more and more evident in our society, researchers are racing to find an adequate antidepressant alternative without the psychotic adverse effects.

According to a recent article in the Nature Reviews research journal, scientists have done just that. Monica Hoyos Flight’s article, “Phase 2 boost for glutamate-targeted antidepressants,” discusses the results of a phase 2 trial that suggest lanicemine as an alternative antidepressant with minimal adverse psychotomimetic effects. Flight also names several NMDA receptor blocking agents, including VistaGen Therapeutic’s AV-101.

Scientists at Yale University in collaboration with AstraZeneca conducted a trial to study 152 patients with moderate-to-severe depression and a weak response to antidepressants. Like ketamine, lancemine showed efficacy as an NMDA receptor antagonist, a key feature in bringing relief of depressive symptoms. Results showed a significant improvement in the level of depression in patients administered lanicemine vs. placebo, without hallucinations or psychotic symptoms.

But for lanicemine to gain approval and clinical acceptance, it must demonstrate robust effects comparable to ketamine, provide rapid onset relief, and have a toxicology profile that shows safety if the drug is taken daily.

“The race is on to introduce safe and effective rapidly acting antidepressants for the most seriously ill mood disorder patients,” Flight quotes Sanjay J. Mathew, at the Michael E. Debakey VA Medical Center in Houston, Texas, as saying. “There are multiple such agents in early phases of development, including S-ketamine (the S-isomer of the racemic ketamine), GLYX-13 (a partial NMDA receptor agonist) and AV-101, a selective blocker of the regulatory GlyB site of the NMDA receptor.”

AV-101 is VistaGen’s lead small molecule drug candidate, which has successfully completed phase 1 development in the U.S. for the treatment of neuropathic pain. The company has been awarded more than $8.8 million from the Nation Institute of Health for further development of AV-101, and VistaGen believes that its phase 1 safety program will enable phase 2 development of the drug candidate for neuropathic pain, other neurological conditions and depression.

With researchers and scientists from some of the nation’s leading academic institutions conducting studies for the highly sought discovery of an alternative to ketamine for the treatment of depression, VistaGen has positioned itself for potential among the ranks of leading candidates.

For more information, visit www.vistagen.com

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VistaGen Therapeutics, Inc. (VSTA) – Utilizing Stem Cell Technology to Develop High Potential Drug Candidates

Tuesday, December 3rd, 2013

VistaGen is a biotech company applying its human pluripotent stem cell (hPSC) technology for drug rescue, including predictive toxicology and drug metabolism screening.

The company’s human pluripotent stem cell (hPSC) technology platform, Human Clinical Trials in a Test Tube™, is based upon a combination of the company’s proprietary and exclusively licensed hPSC technologies.

The platform assesses the toxicity and metabolism (drug-drug interaction) profile of new small molecule drug candidates applicable to a wide range of diseases and conditions. The platform is designed to work at an accelerated and more precise rate than non-clinical in vitro techniques and technologies currently used by biotechnology and pharmaceutical companies.

Among other products, AV-101 is VistaGen’s novel, orally available prodrug candidate for the treatment of neuropathic pain, depression, and potentially other neurological conditions.

In preclinical studies, AV-101 demonstrated positive levels of oral bioavailability, rapid and efficient transport across the blood-brain barrier, and preferential conversion into 7-CKYNA at the site of seizures and potential neural damage in the brain and spinal cord.

The candidate has undergone successful phase 1 development, funded by an $8.8 million grant from the U.S. National Institutes of Health, under an active Investigational New Drug (IND) application with the U.S. FDA.

For more information, visit www.vistagen.com

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Progress in the Development of VistaGen’s (VSTA) AV-101 Prodrug Candidate for Treating Neuropathic Pain and Depression

Friday, November 22nd, 2013

With grant funding from the U.S. National Institutes of Health (NIH), biotechnology company VistaGen Therapeutics, Inc. has successfully completed Phase 1 development of AV-101, an orally available small molecule prodrug candidate. AV-101 is targeted at the multibillion-dollar neurological disease and disorder market, including depression and neuropathic pain, which is a serious and chronic condition that causes pain after an injury or disease of the peripheral or central nervous system. In support of the company’s nonclinical and Phase 1 clinical development of AV-101, the NIH awarded VistaGen more than $8.8 million in grant funding.

Also known as “L-4-chlorokynurenine” and “4-CI-KYN,” AV-101 is converted in the brain into 7-chlorokynurenic acid (7-CI-KYNA), an active metabolite and an agonist of the N-methyl-D-aspartate (NMDA) receptors. One of the most potent and selective blockers of the regulatory GlyB-site of the NMDA receptor, 7-CI-KYNA is a synthetic analog of kynurenic acid, which is a naturally occurring CNS regulatory compound.

AV-101 demonstrated very good levels of oral bioavailability in preclinical studies, as well as rapid and efficient transport across the blood-brain barrier and preferential conversion into 7-CI-KYNA at the site of seizures and potential neural damage in the brain and spinal cord.

VistaGen believes the safety studies completed in its AV-101 Phase 1 program may enable Phase 2 development of the drug for both neuropathic pain and depression. AV-101 has the potential to treat other neurological conditions, as well.

For more information, visit www.vistagen.com

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VistaGen Therapeutics, Inc. (VSTA) Turns Back Time to Give Once-Promising Drug Candidates a Second Chance

Thursday, November 14th, 2013

VistaGen Therapeutics, a biotechnology company, is blazing new trails by looking to the past. The company has developed a pioneering stem cell technology platform that can give a second chance to potentially lifesaving drugs that have been shelved during human trials – essentially turning back the clock for stymied drug candidates and giving them a new pathway to success.

Human Clinical Trials in a Test Tube is VistaGen’s revolutionary human pluripotent stem cell (hPSC) technology platform, offering the pharmaceutical world a gateway through which formerly discontinued drug development candidates can potentially make a comeback. The platform surpasses animal testing and other nonclinical techniques and technologies currently being used in drug development. These presently used methods can only approximate human biology in their attempts to predict the outcomes of a drug candidate, which has spelled disaster and a dead end for countless drug candidates when they reached human trials.

Pharmaceutical companies spend years and millions of dollars developing drugs that show great therapeutic and commercial potential in preclinical development, only to have them fail at the human trial stage because of unanticipated heart or liver toxicity or metabolism issues in human subjects. That fast, a massive investment goes down the drain and the world loses a potentially lifesaving and life-altering drug. But with Human Clinical Trials in a Test Tube, VistaGen can potentially change all that.

Human Clinic Trials in a Test Tube overleaps the limitations of animal and in vitro cell testing and offers a predictive toxicology screening system which much more closely emulates human biology early in the drug development process – long before real human subjects ever encounter the drug. Using this hPSC technology, VistaGen can not only help pharmaceutical companies experience greater success in their drug development efforts, but the company will be able to create its own diverse pipeline of new, proprietary drug rescue variants of discontinued small molecule candidates that were ultimately discontinued due to adverse reactions in human test subjects.

VistaGen intends to get a valuable head start in identifying and developing new, safe drug rescue variants by focusing on these once-promising discontinued drug candidates. The company will not only resurrect potentially revolutionary drug candidates – it will save a great deal of time and money on its journey to bring new drugs to market.

For more information, visit www.VistaGen.com

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VistaGen Therapeutics, Inc. (VSTA) Management Guides Company Advancement with Broad Range of Industry Expertise

Friday, November 8th, 2013

VistaGen Therapeutics has developed a versatile human pluripotent stem cell (hPSC) technology platform based on the controlled differentiation of hPSCs into mature, non-transformed, human cells. The company’s goal is to integrate this hPSC technology with modern medicinal chemistry to create a diverse drug pipeline consisting of new, proprietary, small molecule variants (Drug Rescue Variants) of once-promising drug candidates.

At the forefront of operations is CEO Shawn K. Singh, J.D., who has more than 20 years of experience working with successful public and private biotechnology and pharmaceutical companies, a life sciences venture capital firm, and a profitable contract research and development organization (CRO).

H. Ralph Snodgrass, Ph.D., founder and former CEO of VistaGen, is the company’s chief scientific officer. He has more than 18 years of experience in senior biotechnology management and, among other achievements, is a published and recognized pioneering expert in stem cell biology with more than 20 years of experience using stem cells as biological tools for drug discovery and development.

Jerrold D. Dotson provides financial direction for VistaGen as the company’s chief financial officer. His background covers a broad base of financial experience, including holding various positions in the finance and administration department of Calypte Biomedical Corp., including his last position as vice president of finance and administration and corporate secretary, California & Hawaiian Sugar Company, and The Clorox Company.

Vice president of corporate development, A. Franklin Rice, MBA, joined VistaGen in 1999. He has been employed in the biotechnology industry since 1988, previously serving as senior director of business development at Genencor International and vice president of biotechnology and pharmaceuticals for Bechtel Group where he was responsible for global sales and marketing of consulting services to biotechnology and pharmaceutical companies.

Collectively, VistaGen’s management team is advancing the company’s Human Clinical Trials in a Test Tube™ and working to strengthen the company’s presence in the lucrative biotech industry.

For more information, visit www.vistagen.com

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VistaGen Therapeutics, Inc. (VSTA) Addressing Costly, Far-Reach Neuropathic Pain Condition with Development of Lead Candidate AV-101

Thursday, October 31st, 2013

Neuropathic pain is a serious and chronic condition that affects millions of people around the world. This pain follows damage or disease of the peripheral or nervous system, resulting in a variety of abnormal sensations such as the feeling of electric shock, burning or coldness, numbness and itching, or “pins and needles.”

Recent market research estimates that more than 1.5 billion people worldwide are afflicted with neuropathic pain, costing the U.S. public health system alone between $560 billion – $635 billion annually, according to the American Academy of Pain Medicine.

Small-cap company VistaGen Therapeutics’ lead small molecule drug candidate, AV-101, is being developed in the United States for the treatment of neuropathic pain. AV-101 is also being developed for additional indications, such as depression and other neurological indications.

To-date, the company has been awarded more than $8.8 million from the National Institute of Health for the development of this treatment.

In preclinical studies, AV-101 demonstrated positive levels of oral bioavailability, rapid and efficient transport across the blood-brain barrier, and preferential conversion into 7-CKYNA at the site of the patient’s seizures and potential neural damage in the brain and spinal cord.

So far the drug candidate has completed phase 1 development in the United States under and active Investigational New Drug (IND) application with the U.S. Food and Drug Administration.

VistaGen Therapeutics believes that safety results from the completed phase 1 program has the potential to position the candidate for phase 2 development for both neuropathic pain and depression.

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VistaGen’s (VSTA) Human Clinical Trials in a Test Tube Set to Rescue Once-Promising Drug Candidates

Wednesday, October 23rd, 2013

The limitations of current animal and in vitro cell culture testing have long been a stumbling block for pharmaceutical companies as they endeavor to develop new lifesaving drugs. A drug candidate that has shown great promise in preclinical development can come to a dead end in human trials due to unanticipated heart or liver toxicity or metabolism issues, costing pharmaceutical companies hundreds of millions of dollars they’ve invested in discovering, optimizing, and validating the potential efficacy of the drug candidate. However, one biotechnology company is working to remedy this problem by meeting the tremendous need for predictive toxicology screening systems with greater accuracy.

VistaGen Therapeutics is currently developing Human Clinical Trials in a Test Tube, a versatile new stem cell technology platform that will bring human biology to the forefront of drug development.

Human Clinical Trials in a Test Tube provides clinically relevant predictions of the potential toxicity of new drug candidates long before they ever reach human trials. Human biology can only be approximated by animal testing and other nonclinical techniques and technologies currently being used in drug development, but VistaGen’s human pluripotent stem cell-based bioassay systems are able to much more closely emulate human biology. Ultimately, the company’s revolutionary stem cell technology platform is expected to result in greater success for pharmaceutical companies and their drug candidates that have been stalled in human trials.

By overcoming the limitations of current testing methods, VistaGen hopes to enable pharmaceutical companies to recapture substantial value from their prior investments in drug candidates that were once promising. The company’s goal is to create, using its stem cell technology, a diverse pipeline of new proprietary small molecule variants (drug rescue variants) of small molecule drug candidates that once showed great potential but have been discontinued by pharmaceutical companies, the NIH, or academic laboratories due to heart or liver toxicity or metabolism concerns in humans. By focusing exclusively on these discontinued drug candidates that showed positive preclinical efficacy data, VistaGen believes it will capture a valuable advantage in its efforts to identify and develop new, safe drug rescue variants faster and more cost-effectively than companies that are discovering and developing drug candidates through conventional animal studies and in vitro cell culture testing systems.

Through Human Clinical Trials in a Test Tube, VistaGen and its medicinal chemistry partner will be able to focus drug rescue efforts on generating safer proprietary drug rescue variants and retaining the promising efficacy of discontinued drug candidates with reduced toxicity.

For more information about VistaGen and Human Clinical Trials in a Test Tube, visit www.VistaGen.com

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