Category Archives: VistaGen Therapeutics Inc. VSTA

Economic Impacts of Depression Impacts are Staggering – VistaGen Therapeutics (VSTA) Aggressively Pursues Treatment

February 27, 2015

If you think depression only affects the individual suffering from the disorder, or even their friends and family, think again. As a nation, depression affects all of us in one way or another. According to a report from the Journal of Clinical Psychology, a staggering amount of that impact is economic.

Depression (MDD) is the leading cause of disability for people aged 15-44, reports OptumHealth Reporting and Insights. Financially, that equates to billions of dollars spent on workplace costs, direct costs (which includes medical claims and pharmaceuticals) and suicide-related costs. Annual costs of MDD rose 21% to $210.5 billion in 2010, according to the Journal of Clinical Psychology, compared to costs in 2005.

Most experts agree that depression rates worldwide are on the rise. While there are nearly 50 variations of anti-depressants available in the U.S. alone, the often extensive trial and error process of finding a drug combination that reduces a patient’s depression symptoms is known to take months, even more than a year, and involves risks of serious side effects, including suicide. Studies show that fewer than 40% of depression sufferers benefit from first round treatments with current antidepressants, and the likelihood of achieving remission of depressive symptoms declines with each successive treatment attempt. Even more atrocious, as many as 15% of individuals suffering with MDD commit suicide.

There is an obvious, unarguable need for a breakthrough – a new generation of safe and faster-acting antidepressants.

One such candidate is ketamine, often used as an anesthetic but also popular as a dangerous street drug. The risk of potential abuse of ketamine, its intravenous administration, and its psychosis-like side effects somewhat crimp widespread acceptance in the medical field. And yet, ketamine’s rapid-acting effectiveness against treatment-resistant MDD is hard to ignore.

In San Francisco, a publicly traded, clinical-stage biopharmaceutical company is hard at work advancing its equally, if not more promising, solution – AV-101, an orally active NMDA receptor modulator.

Backed with funding by the U.S. National Institutes Health (NIH), VistaGen Therapeutics is collaborating with Dr. Carlos Zarate – a highly esteemed NIH clinician known for his deep experience with ketamine and other NMDA receptor antagonists – on a phase 2 clinical study of the efficacy and safety of AV-101 in subjects with MDD. As reflected by the NIH’s support, VistaGen’s AV-101 has the potential to deliver the rapid-acting antidepressant effects of ketamine, but without any of ketamine’s serious side effects.

Dr. Carlos Zarate is among the NIH’s leading clinical researchers on depression and other mood disorders, serving as the Chief of the Section on the Neurobiology and Treatment of Mood Disorders and Chief of the Experimental Therapeutics and Pathophysiology Branch at the National Institutes of Mental Health (NIMH). He will be the principal investigator of the NIH-funded Phase 2 study of AV-101 in MDD. VistaGen and the NIH anticipate completing this important study in 2015.

In two prior NIH-funded randomized, double-blind, placebo-controlled phase 1 safety studies, AV-101 was well-tolerated and not associated with any severe adverse events. Nor were there any signs of sedation, hallucinations or schizophrenia-like side effects often associated with ketamine.

In addition to its candidacy as an effective MDD treatment, preclinical studies have also shown AV-101 as a potential as a treatment for other widespread CNS-related conditions, including chronic neuropathic pain and epilepsy, Parkinson’s and Huntington’s disease.

For more information, visit www.vistagen.com

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VistaGen Therapeutics, Inc. (VSTA) Working to Revolutionize Depression Treatment

February 24, 2015

Ketamine has been shown as an extremely effective treatment for patients suffering from major depressive disorder (MDD). Unfortunately, its prospects for widespread therapeutic use are exceptionally limited because of its high potential for abuse, dissociative and psychosis-like side effects, and required intravenous administration in a medical center.

VistaGen Therapeutics, Inc. (OTCQB: VSTA), a clinical-stage biopharmaceutical company, is currently collaborating with Dr. Carlos Zarate and the U.S. National Institutes Health (NIH) on an NIH-funded Phase 2 clinical study of its new drug candidate, AV-101, for the treatment of MDD.

The industry is buzzing about AV-101, which is orally-active, because it may rapid-acting antidepressant benefits that are extremely similar to intravenous ketamine, without ketamine’s limiting side effects. “We are excited by the strong preclinical efficacy data supporting the ketamine-like antidepressant effects of AV-101, as well as the rapid and efficient oral-delivery and clinical safety range demonstrated by our successful Phase I clinical studies,” said H. Ralph Snodgrass, President and CSO of VistaGen. The company expects to complete its Phase 2 study by the end of this year.

While current MDD medications are part of a multi-billion dollar global antidepressant market, the available treatments have limited effectiveness in many cases. Although two out of three patients eventually find a drug combination that induces remission of their depression symptoms, the trial and error process that is presently in use is known to increase the risks of patient tolerability issues and serious side effects. Sadly, as many as 15 percent of individuals suffering with MDD commit suicide as a result.

AV-101’s mechanism of action is fundamentally different compared to current MDD medications. AV-101 works by modulating NMDA receptor channel activity by selectively binding to, and blocking, the glycine-binding co-agonist site of the NMDA receptor. By targeting the glycine-binding co-agonist site, the company’s drug candidate can bypass the adverse effects associated with ketamine without eliminating its surge of glutamate, which provides a powerful antidepressant effect to the patient. VistaGen’s AV-101 could prove to be the perfect solution to correct the flaws in the current treatment process.

MDD is a widespread and debilitating mental disorder affecting nearly 7 percent of U.S. adults. VistaGen, through its AV-101, could be on the brink of a breakthrough for MDD patients who do not benefit from existing antidepressants.

For more information on the company, visit www.vistagen.com

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VistaGen Therapeutics, Inc. (VSTA) Partners with NIH in its Sponsored Phase 2 Study of Orally-Active AV-101 in MDD

February 17, 2015

VistaGen Therapeutics, a clinical-stage biopharmaceutical company focused on developing innovative medicine for depression and conditions associated with the central nervous system, has entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. National Institute of Mental Health (NIMH), a component of the U.S. National Institutes of Health (NIH). The CRADA enables VistaGen and the NIMH to partner on an NIH-sponsored Phase 2 clinical study of AV-101 in subjects with Major Depressive Disorder (MDD). MDD is a pervasive and debilitating mental disorder which affects millions of people worldwide. It has been noted that as many as 7% of all adults have some form of MDD.

Dr. Carlos Zarate, Chief of the Section on the Neurobiology and Treatment of Mood Disorders and Chief of the Experimental Therapeutics and Pathophysiology Branch at the NIMH, will be the Principal Investigator of the NIH-funded study, which will be a randomized, double-blind, placebo-controlled, crossover Phase 2 clinical trial designed to study the efficacy and safety of an oral dose of AV-101 taken once per day for two weeks. The study involves approximately 25 subjects with MDD. The main efficacy measure will be the Hamilton Depression Rating Scale (HDRS) – the subject standard for measuring the severity of MDD. The study is anticipated to be completed this year.

Mr. H. Ralph Snodgrass, VistaGen’s President and CSO, commented, “We are excited by the strong preclinical efficacy data supporting the ketamine-like antidepressant effects of AV-101, as well as the rapid and efficient oral-delivery and clinical safety range demonstrated by our successful Phase 1 clinical studies. Dr. Zarate and his team have deep experience with ketamine and other NMDA receptor antagonists. We look forward to collaborating closely with them to complete this important AV-101 Phase 2 study in MDD by year end.”

While the majority of people will experience moods of depression at some point during their lives, it should not be confused with clinically diagnosed MDD. MDD is the chronic, pervasive feeling of unhappiness and suffering, impairing how one functions. Symptoms of MDD include lower levels of pleasure in activities, insomnia or hypersomnia, weight changes, fatigue, feelings of worthlessness and guilt, poor concentration, suicidal thoughts and psychomotor agitation. It has been estimated that suicide is the cause of death in as much as 15% of individuals with MDD.

Current medications available in the multi-billion dollar global antidepressant market are known to have limited effectiveness. Because of this, their mechanism of action, SSRIs and SNRIs, must be taken for several weeks before patients experience any significant therapeutic benefit. Studies show that over 60% of depression sufferers do not benefit from first round treatments, and the likelihood of achieving remission of depressive symptoms declines with each successive treatment attempt.

In the placebo-controlled, double-blind clinical trials conducted by Dr. Zarate and others at the NIMH, ketamine produced expedient antidepressant effects in MDD patients who had not responded to approved antidepressants. Although the potential for widespread therapeutic use of ketamine is limited by its potential for abuse, dissociative and psychosis-like side effects, and practical challenges associated with its required intravenous administration in a medical center, the discovery of ketamine’s rapid onset antidepressant effects revolutionized thinking about the MDD treatment paradigm and mechanism of action of antidepressant medicines. The discovery also increased interest in the development of a new generation of antidepressants with a mechanism of action similar to ketamine’s, including a more rapid therapeutic benefit compared to existing agents.

AV-101’s fundamentally novel mechanism of action places it among a new generation of glutamatergic antidepressants with potential to address millions of MDD sufferers worldwide who are poorly served by SSRIs, SNRIs and other current depression therapies. Similar to ketamine, AV-101 down-regulates NMDA receptor channel activity. However, unlike ketamine’s antagonistic activity, which results from its blocking the NMDA receptor channel, AV-101’s antagonistic activity results from its selective binding to, and blocking of, the functionally-required glycine-binding co-agonist site of the NMDA receptor. Targeting the glycine-binding co-agonist site of the NMDA receptor may bypass potential adverse effects that occur with ketamine without affecting the robust efficacy observed in previous clinical studies. This may then result in the “glutamate surge” that has been associated with the rapid-acting antidepressant effects of ketamine.

To date, NIH has awarded VistaGen $8.8 million to advance its preclinical and Phase 1 clinical development of AV-101. In two randomized, double-blind, placebo-controlled Phase 1 safety studies, AV-101 was well tolerated and not associated with any severe adverse events. There were no signs of sedation, hallucinations or schizophrenia-like side effects often associated with ketamine and traditional NMDA receptor channel blockers.

VistaGen is a clinical-stage biopharmaceutical company developing innovative medicine for depression and conditions involving the central nervous system. VistaGen’s AV-101 is a new generation orally-available NMDA receptor glycine B-site antagonist now moving into Phase 2 clinical development for MDD. Preclinical studies to date have shown that AV-101 may also have potential as a treatment for other CNS-related conditions, including chronic neuropathic pain and epilepsy, Parkinson’s and Huntington’s disease. VistaGen is using its proprietary pluripotent stem cell technology and clinically-predictive bioassay systems, CardioSafe 3D™ and LiverSafe 3D™, for drug rescue applications focused on producing proprietary, novel new chemical entities (NCEs) that are safer versions of drug candidates previously optimized and tested for efficacy by pharmaceutical companies.

For more information on the company, visit www.vistagen.com

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VistaGen Therapeutics, Inc. (VSTA) Welcomes Dr. Gerard Sanacora to Clinical and Scientific Advisory Board

February 5, 2015

VistaGen Therapeutics, a clinical-stage biopharmaceutical company developing innovative medicine for depression and conditions involving the central nervous system, has expanded its Clinical and Scientific Advisory Board with the addition of Gerard Sanacora PhD, MD, professor of psychiatry at the Yale School of Medicine and director of the Yale Depression Research Program.

“Dr. Sanacora and his colleagues at Yale Depression Research Program are among the global leaders in the discovery and elucidation of ketamine’s mechanism of action in depression,” Shawn Singh, CEO of VistaGen, stated in the news release. “His extensive research and recent clinical experience with the use of ketamine for treating [major depressive disorder] will be highly valuable as we advance AV-101 into late-stage development for depression and other [central nervous system] indications.”

Dr. Sanacora will focus on phase 2 and phase 3 clinical development of AV-101, VistaGen’s orally active NMDA receptor modulator for treating major depressive disorder (MDD). AV-101 is a unique prodrug candidate that produces, in the brain, 7-chlorokynurenic acid (7 Cl KYNA), one of the most potent and selective antagonists of the required glycine-binding site of the NMDA receptor, which results in down-regulation of NMDA signaling.

Previous MDD clinical studies of ketamine conducted by the NIH, Yale and others demonstrated rapid relief of depressive symptoms in treatment-resistant MDD patients, providing compelling clinical evidence of the key role of NMDA receptor modulators in a new MDD treatment paradigm. The studies also support AV-101’s potential as a novel rapid onset treatment for MDD.

“The relatively recent discovery of ketamine’s rapid onset antidepressant effects revolutionized our thinking about antidepressant medicine, ushering in development of a new generation of drug candidates with a fundamentally novel mechanism of action compared to the agents that form the mainstay of current depression treatment,” Dr. Sanacora stated. “VistaGen’s AV-101 is among the new generation of antidepressants that modulate the NMDA receptor and may act to normalize glutamate signaling to achieve the rapid and sustained antidepressant benefits of ketamine without ketamine’s significant negative side effects.”

In two randomized phase 1 safety studies funded by the National Institutes of Health (NIH), AV-101 was well tolerated without any serious adverse events or signs of sedation, hallucinations or the schizophrenia-like side effects often associated with ketamine.

VistaGen has signed a Letter of Intent with the National Institute of Mental Health (NIMH) to enter into a Cooperative Research and Development Agreement (CRADA) to collaborate with Dr. Carlos Zarate and his colleagues at the NIMH on an NIH-sponsored phase 2 clinical study of AV-101 in MDD. Under the proposed CRADA, Dr. Zarate, who serves as chief of the Section on the Neurobiology and Treatment of Mood Disorders and chief of the Experimental Therapeutics and Pathophysiology Branch at the NIMH, will be the principal investigator for the study.

For more information visit www.vistagen.com

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VistaGen Therapeutics, Inc. (VSTA) – Applying Stem Cell Technology toward Drug Rescue and New Generation Drug Toxicity Screening

January 26, 2015

Believing that better cells lead to better medicine, VistaGen Therapeutics has been applying pluripotent stem cell technology toward drug rescue, predictive toxicology and drug metabolism screening.

VistaGen’s activities are guided by the belief that the key to making better cells is strictly controlling the differentiation of human pluripotent stem cells, the building blocks of all cells in the human body. For more than 15 years, the company’s stem cell research and development teams and collaborators have developed proprietary methods for controlling the differentiation of human pluripotent stem cells and the production and maturation of several specific types of adult human cells, particularly human heart and liver cells.

VistaGen’s drug rescue activities are focused on combining its stem cell technology and assay development expertise with modern medicinal chemistry to produce drug rescue variants – new, safer chemical variants of once-promising drug candidates that have positive data supporting their therapeutic and commercial potential, but that were halted in development by the pharmaceutical companies or university laboratories because of concerns about potential heart or liver toxicity or metabolism issues.

In the years since VistaGen was founded, the California-based biotechnology company has developed two customized bioassay systems designed to transform drug development by establishing clinically-predictive, human cell-based toxicology screening at the front end of the development process, long before animal or human studies:

• CardioSafe 3D™ – This customized human heart cell bioassay system for screening potential heart toxicity of new drug candidates uses mature, functional, adult human heart cells produced from pluripotent stem cells (VSTA-CMs™) to detect a far broader range of potential cardiac toxicities than the FDA-required hERG assay, and it provides proprietary cardiac toxicity and quantitative structure-function (QSAR) information to guide highly-efficient selection and development of proprietary drug rescue candidates for VistaGen’s pipeline.

• LiverSafe 3D™ – VistaGen is developing and validating this innovative, three-dimensional in-vitro bioassay system designed to evaluate liver toxicity and drug metabolism issues. LiverSafe 3D uses VSTA-heps™, VistaGen’s pluripotent stem cell-derived, mature adult human hepatocytes (liver cells). VSTA-heps have significantly more functionally useful life span in culture than primary (cadaver) hepatocytes and overcome the key problems related to use of primary hepatocytes for in vitro liver safety toxicity and drug metabolism screening, including: extreme variation in functional activity; limited supply; unknown health status of donor; and genetic differences.

VistaGen continues employ its world-class stem cell differentiation and bioassay development expertise to expand the scope of its drug rescue, drug discovery and strategic collaboration opportunities worldwide.

For more information, visit the company’s website at www.vistagen.com

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VistaGen Therapeutics, Inc. (VSTA) Making Impressive Strides in Curbing Costs Associated with Depression Treatments

January 14, 2015

Since inception, VistaGen Therapeutics has focused on creating human cell-based biological assay systems that reveal the potential toxic effects of new drug candidates before they are tested in animals or humans. Today’s next-generation biological assays are delivering needed preclinical human cardiac data, soon to be followed by human liver data, that will increase the likelihood of selecting safer therapeutics for clinical development.

AV-101 is VistaGen’s proprietary, novel oral clinical-stage drug candidate that is fast emerging as a prominent player in a small group of new generation of drug candidates focused on the multi-billion dollar global antidepressant market.

Despite the availability of numerous very similar antidepressant drugs over the past 50 years, millions of depression patients remain underserved by their current therapies and many require several weeks before therapeutic benefits are achieved. Ketamine, a classic NMDA receptor (NMDAR) channel blocker, has been shown in human clinical studies run by the U.S. National Institutes of Helath (NIH) and others to act rapidly to alleviate symptoms of depression in treatment-resistant patients suffering with Major Depressive Disorder (MDD). However, the potential for widespread clinical and commercial use of ketamine has been severely limited by its high risk for abuse and behavioral impairment, and its requirement for i.v. administration in a clinical setting. VistaGen’s AV-101 is a oral, NMDAR glycine (B)-site antagonist, with a novel mechanism of action compared to all currently available antidepressants. In two randomized, double-blind, placebo-controlled Phase I clinical studies, AV-101 was well-tolerated, without serious adverse outcomes. AV-101 has the potential to deliver the rapid onset antidepressant effects of ketamine without ketamine’s –psychosis-like side effects. VistaGen and the NIH are currently planning to collaborate on an important NIH-sponsored Phase 2 clinical efficacy study of AV-101 in MDD patients in 2015.

For more information on the company and its offerings, visit www.vistagen.com

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VistaGen Therapeutics, Inc. (VSTA) is Optimistic About Its Depression Medicine

January 6, 2015

Depression, as many of us know, is more than just a sad or melancholy mood. It’s more than just having “the blues.” Sometimes it can be a very debilitating condition that can prevent people from having productive lives – and in some cases can be a root cause of suicide and/or fatal drug overdoses.

Depression is often considered an imbalance of certain chemicals in the brain, and is treated through various therapies and anti-depressant drugs. However, the very serious level of depression – the living-in-an-abyss type of depression that was behind the recent death of actor and comedian Robin Williams (also known as Major Depressive Disorder, or MDD) – has been very difficult to treat effectively. There has been a trade-off with some therapies – there are some strong anti-depressants in the market, but most have side effects that can be dangerous in their own right – perhaps more so than the depression itself. VistaGen Therapeutics, Inc. (OTCQB: VSTA) is looking to fill this very important mental-health gap with its own potential new antidepressant therapy known as AV-101.

VistaGen’s AV-101 has gone through the initial Phase 1 clinical development focused on human safety and the company is now working toward a significant Phase 2 clinical trial of AV-101 in collaboration with the U.S. National Institutes of Health (NIH). The NIH previously awarded the company nearly $9 million for its preclinical and Phase 1 development programs, and the company expects the NIH to sponsor and conduct the impending Phase 2 efficacy study. VistaGen believes AV-101 is a potential new generation antidepressant with a novel mechanism of action to address MDD more rapidly and with fewer and less-severe side effects than other depression therapies currently being used.

With a successful Phase 2 trial which is expected to be completed by the end of 2015, there could be some significant momentum for VistaGen Therapeutics in the mental-health sector, with AV-101 as a novel potential therapy for MDD and other similar mood disorders that affect millions of Americans. Robin Williams’ sad and tragic death has brought MDD more prominently into the forefront, and it will be therapies like AV-101 that will be watched more readily as mental-health professionals look to encourage more diagnoses of depression and other mood disorders so they can be treated early and aggressively. This is an environment for VistaGen Therapeutics to be in the spotlight.

For more information, visit www.vistagen.com

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VistaGen Therapeutics, Inc. (VSTA) – Developing Leading-Edge Biotechnology Offerings

December 26, 2014

VistaGen Therapeutics is bringing human biology to the front end of the long and costly drug development process. Among the most troubling aspects of drug development are unexpected heart and liver toxicities that often arise during human testing. Applying its stem cell technology and the human heart and liver cells it produces from stem cells, the company’s new generation of customized biological assay systems have been designed to predict early in development how humans will respond to new drug candidates in the long run.

In the years since VistaGen was founded, its technological advancements are finally catching on and allowing the founders of the company to realize their dream: to create the type and quality of human cell-based biological assay systems that provide a real understanding of the potential therapeutic and toxic effects of new drug candidates long before they are ever tested in animals or humans. Today’s next-generation biological assays are indeed providing crucial preclinical human cardiac data, soon to be followed by human liver data, that will increase the likelihood of selecting safer therapeutics for clinical development.

VistaGen has focused on developing various offerings over the years, including a novel clinical-stage drug therapy that has emerged as a leading new drug candidate in the multibillion dollar global antidepressant market. These offerings include:

• AV-101 – an orally-available small molecule drug candidate VistaGen has under clinical development. This therapy has completed the first phase of development for the treatment of a number of neurological diseases and disorders. This list includes Major Depressive Disorder and chronic neuropathic pain, both disabling conditions affecting millions around the world.

• CardioSafe 3D™ – the company’s human heart cell-based bioassay system that, following significant development, is demonstrating a propensity for being a clinically-predictive system for the preclinical cardiac safety screening of new drug candidates, including anti-cancer drug candidates such as kinase inhibitors, a new category of drugs that has revolutionized cancer therapy because of its increased target cell efficacy and reduced systemic toxicity when compared to classic cancer drugs and other therapeutic compounds. VistaGen is using CardioSafe 3D to expand its internal pipeline through various “drug rescue” programs. The goal of these drug rescue programs is to re-engineer or re-design (that is, rescue) once-promising new drug candidates developed by large pharmaceutical companies but abandoned before FDA-approval due to heart toxicity issues. The company believes the broad range of insightful heart toxicity data it can generate using CardioSafe 3D will give it a valuable head start in its and its collaborators’ efforts to re-design and develop a new, VistaGen-owned variant of these once-promising drug candidates, each with the same therapeutic potential as the original but without the heart toxicity issues.

• LiverSafe 3D™ – an innovative, customized, three-dimensional in-vitro bioassay system being validated to complement CardioSafe 3D for drug rescue applications. Using human liver cells produced from stem cells, the company is planning to use LiverSafe 3D™ to evaluate potential drug rescue candidates with metabolism and liver toxicity issues.

For more information, visit the company’s website at www.vistagen.com

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VistaGen Therapeutics, Inc. (VSTA) AV-101 Rivals Ketamine and Other Next-Gen Anti-depressants

December 16, 2014

On the street ketamine is referred to as “Special K,” a drug popular in the party scene because of its hallucinogenic and other psychotomimetic, or psychosis-like, effects. In the operating room, ketamine has long been used for general anesthesia, and a growing body of research also shows ketamine as highly effective at treating depression, especially in patients who are inadequately treated by currently marketed antidepressants – treatment-resistant patients with Major Depressive Disorder. It’s the dangerous chasm between illicit party drug and FDA-approved general anesthetic that raises concern over using ketamine as an antidepressant. The upside is that the continued focus on depression unveils breakthrough alternative treatments currently in development and a changing paradigm for treating Major Depressive Disorder.

Most currently available antidepressant drugs act on serotonin and related neurotransmitter pathways in the brain and require a long lag in onset of antidepressant effects, usually requiring several weeks of administration before therapeutic benefits are achieved. But about 10 years ago, researchers recognized that ketamine has properties that within a matter of hours help alleviate symptoms of patients with Major Depressive Disorder.

A more rapid-acting antidepressant would have a phenomenal impact on the treatment of depression, and the National Institute of Mental Health (NIMH), part of the National Institute of Health (NIH), is among those researching ketamine’s potential for this indication.

Dr. Carlos Zarate, Chief of Experimental Therapeutics and Pathophysiology at the NIMH, is conducting a Phase 2 clinical trial to examine whether ketamine can cause a rapid-next day antidepressant with longer lasting effects. In a previous study, ketamine produced a rapid antidepressant effect within hours, but the effect lasted less than one week.

As highlighted in an article on NPR, Dr. Zarate’s previous study of 30 depressed patients who were dosed with ketamine did in fact demonstrate changes in brainwave activity that indicated the drug is capable of strengthening connections between neurons in areas of the brain associated with depression.

While these studies and others raise new hope for depression patients, especially for treatment-resistant major depression patients, the primary concerns of using the ketamine for this indication remain.

Among those concerns are the requirement of intravenous (IV) administration in a clinical setting, serious psychiatric effects of the drug, risk of abuse, and the lack of long-term studies. While some clinics provide ketamine that patients can self-administer via IV at home, the practice is a rare departure from the standard practice of monitoring patients when they take the drug.
Pharmaceutical companies hope to dissolve many of these challenges by developing drugs that utilize ketamine’s depression-alleviating properties without the side effects. GLYX-13, made by a company called Naurex, is one such drug.

In the company’s recently reported phase 2b study of GLYX-13, the new data confirmed the efficacy and safety results from an earlier phase 2 study, which documented the drug’s rapid onset of antidepressant activity within two hours and lasting for an average of seven days.

Additionally, GLYX-13 was well-tolerated with no sign of the psychosis-like effects associated with ketamine. This is unarguably of incredible clinical significance when it comes to advances in antidepressants. The catch? GLYX-13 is administered intravenously, which for most patients is an inconvenient if not unrealistic method of administration on a weekly basis.
Medical advances are the results of perpetual fine tunings of initial clinical achievements. On that note, Dr. Zarate at the NIMH also has an eye out for new generation antidepressants such as GLYX-13, Cerecor’s CER-301, and VistaGen’s AV-101.

Dr. Zarate has agreed to be the principal investigator of an expected Phase 2 depression study of VistaGen’s AV-101, a novel drug candidate that that might be more potent than GLYX-13, again with out ketamine-like side effects. Furthermore, AV-101 is administered orally by capsule.

In two randomized, double-blind, placebo-controlled phase I clinical studies, AV-101 was well-tolerated and without signs of sedation, hallucinations or the schizophrenia-like side effects often associated with ketamine and other similar channel blockers.

The phase 1 studies were conducted at the University of California, San Diego, by Dr. Mark Wallace, a colleague of psychiatrist Dr. David Feifel, one of only a few academic psychiatrists to offer ketamine treatment. In a recent New York Times article, Dr. Feifel notes that the biggest challenge of ketamine as an antidepressant is that the effect quickly wears off.
VistaGen’s upcoming phase 2 trial will study AV-101’s ability to improve overall depressive symptoms in adult subjects with Major Depressive Disorder. The trial is expected to start in the first quarter of 2015, be conducted by Dr. Carlos Zarate of the NIMH, and funded by the NIH, which previously awarded VistaGen $8.8 million of grant funding for its preclinical and phase 1 clinical development of AV-101.

VistaGen believes its orally-available AV-101 candidate has the potential to deliver the same therapeutic benefits of ketamine and other NMDA receptor modulators, but without IV administration or side effects. AV-101 is also an FDA fast track designation candidate and demonstrates additional potential in epilepsy, pain and Parkinson’s disease.

Depression is a huge, debilitating and global public health concern. The World Health Organization reports that approximately 350 million people worldwide suffer from depression –according to the NIHM, 7% of that number are U.S. adults. Though the FDA has approved antidepressants for decades, the treatments fail to adequately provide rapid-acting and long lasting benefits in treatment-resistant patients with Major Depressive Disorder. As evidenced by the recent suicide of actor Robin Williams, whose long battle with depression was widely publicized, there is tremendous need for a new generation of safe and fast-acting antidepressants.

The paradigm of depression treatment is shifting away from the use of FDA-approved, long-lag onset drugs toward faster-acting treatments like ketamine. Despite the challenges associated with ketamine, its growing acceptance among the psychiatric community and national media continues to spread. How much more so will the world embrace a new generation of antidepressant candidates, like GLYX-13 and AV-101, that are in sync with this new paradigm but void of the typical challenges?

For more information about AV-101, visit www.vistagen.com

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VistaGen Therapeutics, Inc. (VSTA) Embarking on Key Stage 2 Clinical Trial of Potential Breakthrough Major Depression Therapy

December 12, 2014

With the very public suicide of actor/comedian Robin Williams recently, the battle with major depressive disorder, or MDD, has moved even more into the public light. VistaGen Therapeutics, Inc. (OTCQB: VSTA) has become one of a small group of companies developing a new generation of antidepressant drugs to combat depression where current antidepressants and other therapies have come up short.

VistaGen is slated early in the New Year to begin a Phase 2 clinical trial of its AV-101 with the National Institute for Mental Health (NIMH), the mental health arm of the National Institutes of Health (NIH), builing on encouraging signs of safety and the drug’s potential to better combat major depression without the lag in onset of therapeutic benefits and some of the serious side effects often associated with currently-available anti-depression therapies and treatments.

With nearly $9 million of prior support from the NIH, VistaGen has been working diligently to develop AV-101 for various diseases and conditions of the central nervous system (CNS), including depression, chronic pain and other CNS disorders, and AV-101 is reportedly showing the notable potential for success in combating one of the most prominent disorders in the world – one which is estimated to affect about 1 in 20 people globally and indirectly impacts families and friends of those sufferers. That potential has now caught the attention of the NIMH, which is expected to collaborate with the company and sponsor its upcoming Phase 2 clinical study of AV0-101 in major depression.

In its NIH-funded Phase 1 clinical trials in healthy volunteers, AV-101 was safe, with no adverse side effects. In those studies, multiple subjects on AV-101 (none on placebo) expressed positive feelings of well-being similar to ketamine’s rapid-onset antidepressant effects, without any of ketamine’s serious side effects. There were no reports of hallucinations, sedation or any schizophrenia-like effects which have been reported with drugs such as ketamine and similar treatments that have produced what are called rapid-onset antidepressant results.

This Phase 2 trial is due to be both started and completed in 2015, offering hope for a potential safe and effective breakthrough treatment for major depression, something that has eluded patients and healthcare professionals for decades.

For more information, visit www.vistagen.com

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VistaGen Therapeutics Inc. (VSTA) AV-101 Poised to Emerge as a Leading Candidate in Multibillion Dollar Global Antidepressant Market

Depression affects nearly 7% of all adults in the U.S. and over 350M people worldwide according to the World Health Organization, and it is a major contributor to overall disease statistics. GBI Research forecasts the global antidepressant market as growing to around $13.4B by 2018 with a CAGR of approximately 1.8%, even though the primary market component, serotonin re-uptake inhibitors (SSRIs), has continued to produce red flags like ill-served patients and a variety of dangerous side effects.

The FDA-approved anaesthetic ketamine is currently used for starting and maintaining anesthesia, with the chief applications being to induce sedation during intensive care or as a serious pain killer. However, ketamine has also more recently been shown to have significant effect as a fast-acting antidepressant in depression patients that don’t respond well to the typical depression medicine available on the market today, such as Prozac, which mostly target monoamine neurotransmitters. Pharmacologically classified as an NMDA (N-methyl-D-aspartate) receptor antagonist, ketamine induces a trance-like state and, in addition to pain relief and sedation, causes memory loss. Ketamine is classified as a dissociative agent alongside other drugs in its class, like PCP (phencyclidine), with side psychotomimetic effects like confusion, seeing flashing lights and bright color, things that make it popular as a club drug of abuse. The clinical and therapeutic emergence of ketamine in major depressive disorder (MDD) has naturally been significantly slowed down, despite its efficacy in placebo-controlled studies at the NIH, due to these acute psychosis-like side effects (and the potential for abuse, despite having to be administered intravenously), opening up a massive opportunity for a new generation of safe and effective, fast-acting drugs giving the benefits of ketamine while minimizing or eliminating these psychotomimetic side effects.

The rush is now officially on to bring such fast-acting antidepressant agents to market, but to gain widespread approval and clinical acceptance, such agents would ideally need to have comparably robust efficacy and rapidity of onset to intravenously (IV) administered ketamine, according to the Global Therapeutic Head of Neuroscience at Johnson & Johnson (NYSE:JNJ), Husseini K. Manji, MD, FRCPC. Dr. Manji has also noted that to truly gain widespread acceptance, such agents really need vital characteristics that further distinguish them from ketamine, like oral availability and a toxicology profile that would make the agent viable for daily or even chronic use.

One such promising new generation agent, GLYX-13, is an IV-administered partial NMDA receptor agonist being developed by a private company, Naurex, Inc. which raised $18M during its launch of Phase 2 efficacy testing for GLYX-13 back in 2011, and that was without any prior clinical efficacy data. To date, based mostly on the potential of GLYX-13, which is currently Phase 3-ready, Naurex has raised over $160M from a broad array of sector heavy-hitters, including Baxter Ventures, the venture capital arm of Baxter International (NYSE:BAX). Naurex’s latest raise brought in $80M this December 3, largely due to positive Phase 2 data showing robust and sustained antidepressant effect in major depressive disorder patients, again with giants like Baxter and Genesys (NSE:GENESYS) on board.

Another promising new generation antidepressant agent, currently entering Phase 2 development, the same pipeline stage as GLYX-13 was in when Naurex raised that first $18M chunk of their development war chest, is AV-101 from VistaGen Therapeutics (OTCQB: VSTA). VistaGen’s share price is highly accessible to investors and the company is currently poised to launch an important Phase 2 clinical efficacy study of AV-101 in early 2015. The company is planning to collaborate with the National Institute of Mental Health (NIMH) under a Cooperative Research and Development Agreement (CRADA) expected to provide NIH sponsorship of the study.

AV-101, a prodrug which is rapidly and enzymatically converted into the established and highly potent NMDAR antagonist, 7-chlorokynurenic acid (7-Cl-KYNA), after crossing the blood-brain barrier, is novel, orally available (in a capsule), non-sedating, and non-hallucinogenic, with no signs of the schizophrenia-like side effects associated with other NMDA channel blockers, such as ketamine. VistaGen’s focus on the glycine binding site (GlyB) within the NMDAR could prove to be one of the best approaches in the new generation antidepressant space to date, potentially offering compelling advantages over competitors like oral-availability and a highly selective method of action.

VistaGen also has an ace up their sleeve, a highly-respected NIH physician with considerable clinical experience using ketamine in major depression, Dr. Carlos Zarate, Chief of the Experimental Therapeutics & Pathophysiology Branch (ETPB) and Section on the Neurobiology and Treatment of Mood Disorders at the NIMH. Dr. Zarate will be conducting the NIH-sponsored Phase 2 efficacy study of AV-101 for major depression early next year. They should have the CRADA hammered out sometime early next month. Savvy investors will want to keep an ear to the ground for developments on AV-101, as this candidate could emerge as one of the leading new generation antidepressants, with therapeutic potential in a variety of central nervous system (CNS) disorders as well, including chronic neuropathic pain, epilepsy and even neurodegenerative diseases like Parkinson’s disease and Huntington’s disease.

For more information on VistaGen Therapeutics, visit: www.vistagen.com

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VistaGen Therapeutics, Inc. (VSTA) Authorizes Letter of Intent with NIMH for NIH-Sponsored Phase 2 Study of AV-101 in Major Depressive Disorder

November 17, 2014

VistaGen signed a Letter of Intent to enter into a Cooperative Research and Development Agreement (CRADA) with the National Institute of Mental Health (NIMH), part of the National Institutes of Health (NIH), to collaborate on a NIMH-sponsored Phase 2 clinical study of VistaGen’s lead drug candidate, AV-101, in Major Depressive Disorder. The disorder is one of the most common in the U.S.

Both VistaGen and NIMH look to complete the CRADA next month and both commencing and completing the Phase 2 depression study in 2015.

AV-101, an oral, non-sedating, non-hallucinogenic, NMDA receptor (NMDAR) glycineB-site antagonist, is a new generation of fast-acting, glutamatergic antidepressants with potential to treat millions of depression patients who are ineffectively served by classic antidepressants. Published NIH placebo-controlled clinical trials show evidence that ketamine, a classic NMDAR channel blocker, produces rapid-onset antidepressant effects. However, intravenously administered clinical utility of ketamine and other NMDAR channel blockers has been badly limited by their potential for abuse and dissociative side effects. By regulating as opposed to blocking NMDAR, AV-101 potentially can achieve the rapid-onset antidepressant effects of ketamine and other classic NMDAR channel blockers – all without causing their serious side effects.

Dr. Carlos Zarate, Chief, Section on the Neurobiology and Treatment of Mood Disorders and Chief of the Experimental Therapeutics and Pathophysiology Branch at the NIH’s National Institute of Mental Health, is expected to be the Principal Investigator of the AV-101 Phase 2 depression study under the proposed Cooperative Research and Development Agreement.

VistaGen CEO, Shawn K. Singh noted, “Depression is a global public health concern, affecting over 350 million people worldwide, including millions in the U.S. We are pleased to be on a specific path headed toward extending our long-standing relationship with the NIH. Collaborating under the new CRADA will provide us and the NIMH with an important near term opportunity to make a major difference in the battle against depression.”

VistaGen is a clinical-stage biopharmaceutical company developing innovative medicine for depression, cancer and diseases and conditions involving the central nervous system. VistaGen’s lead drug candidate, AV-101, is a novel, potent, oral NMDAR glycineB-site antagonist entering Phase 2 clinical development focused on depression.

For additional information, visit the company’s website at www.vistagen.com

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VistaGen Therapeutics, Inc. (VSTA) Sees AV-101 as Potential Breakthrough Drug for Major Depressive Disorder

September 25, 2014

Potential to Address Major U.S. and Global Need

It’s one of the single most sought-after drugs in the medical industry, and biotechnology company VistaGen Therapeutics may have it. What is so desperately needed is a drug able to treat a disease that afflicts tens of millions of people in the U.S., and hundreds of millions globally. The disease is MDD (Major Depressive Disorder), a crippling form of depression that is not effectively treated by existing medications. It is now recognized as a disease that seriously undermines economies and society as a whole, contributing to hundreds of thousands of deaths worldwide each year. The recent death of actor and comedian Robin Williams has shed a public light on the gravity of individual depression, but researchers know that it affects as many as one out of 20 households. They also know the significant issues with standard treatments for MDD.

Current Drugs Too Slow or With Side Effects

Traditional FDA-approved drugs currently used to treat depression are very slow acting, a consequence of the way they operate in the brain. It can take weeks or even months to achieve the intended benefit of these antidepressants, time that patients experiencing an MDD crisis often don’t have. The lack of noticeable and timely results with such treatments can easily discourage people with MDD from continuing with their antidepressant medications. In desperation a patient can slide from one drug to another until they feel they’ve run out of options, potentially with fatal results.

So anxious is the medical establishment for an effective quick-acting anti-depressant that ketamine, a multi-purpose pain killer and anesthetic, has been re-purposed by certain physicians as an anti-depressant, primarily because of its ability to deliver rapid, robust antidepressant effects in MDD patients. An article in Scientific American (http://dtn.fm/gkE0) talked about how the ketamine’s promise has ignited excitement among clinicians and neuroscientists, in spite of its associated adverse effects, pointing out that “a person taking ketamine may experience altered physical, spatial and temporal states; larger quantities may induce hallucinations and dissolution of the self”. Over and above what an article in Nature Reviews (http://dtn.fm/4LjI) called “psychosis-like side effects”, another major problem with ketamine is that it must be given intravenously. Forcing patients to get frequent infusions to stave off depression is nobody’s idea of an optimum solution, but it underscores the serious, unmet medical need in this area.

New Drug May Be Perfect Storm

Amidst all of this has come a highly innovative new approach from California-based VistaGen Therapeutics, a biopharmaceutical company known primarily for its stem cell technology. VistaGen’s novel, orally available MDD drug candidate AV-101 is ready for Phase 2 clinical development in the U.S. and is starting to look like a very big deal, because it offers the promise of being an antidepressant that is both powerful and quick-acting, while at the same time causing none of the mind-bending side effects of ketamine. The drug operates in a different way than the other FDA-approved antidepressant drugs, providing a much more moderated effect while still getting the job done. NIH sponsored Phase 1 studies of AV-101 have already shown it to be a remarkably safe and well-tolerated compound. Perhaps even more notable is the fact that AV-101 can be taken orally, with no need for regular injections or IV administration. It’s an almost ideal combination of properties, with a multi-billion dollar market on the table.

From a technical standpoint, AV-101 (4-Cl-KYN) is an orally-available, non-sedating, non-hallucinogenic prodrug (precursor drug) that is rapidly and enzymatically converted to its active metabolite, 7-chlorokynurenic acid (7-Cl-KYNA), one of the most well-characterized, potent, and selective synthetic blockers of N-methyl-D-aspartate (NMDA) receptors at the glycine-coagonist (GlyB) site. Although the pathophysiology of depression has been linked to monoaminergic mechanisms for decades, compelling evidence now suggests a key role of the glutamatergic system in mood disorders and favors the idea that AV-101’s targeted antagonism of the glycineB site of the NMDA receptor can provide rapid, robust antidepressant effects in treatment of MDD similar to ketamine, but without ketamine’s serious side effects.

VistaGen is currently preparing for a Phase 2 MDD study in early 2015, so keep an eye open for announcements.

In addition to MDD, AV-101 is now also being seen as a potential treatment for other diseases involving the central nervous system, including epilepsy, chronic neuropathic pain, and neurodegenerative disorders such as Parkinson’s disease.

For additional information, visit the company’s website at www.vistagen.com

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VistaGen Therapeutics, Inc. (VSTA) Receives Notice of Allowance for Stem Cell Technology

August 19, 2014

Today before the opening bell, VistaGen Therapeutics announced its reception of a Notice of Allowance from the Canadian Intellectual Property Office. The Notice of Allowance enables further expansion of VistaGen Therapeutics’ intellectual property portfolio, which consists of pluripotent stem cell culture systems that produce human cells of the endoderm lineage, including liver, lung, pancreas, parathyroid and thyroid cells.

The notice pertains to Canadian Patent Application No. 2,487,058, which is exclusively licensed to VistaGen Therapeutics by the Icahn School of Medicine at Mt. Sinai in New York and entitled “Mesoderm and Definitive Endoderm Cell Populations”. This new development builds on VistaGen Therapeutics’ recent reception of another Notice of Allowance for Canadian Patent Application 2,684,022, both of which strengthen the company’s intellectual property portfolio relating to a number of pluripotent stem cell projects VistaGen Therapeutics has been considering pursuing in Canada.

These include: projects that involve liver safety and liver toxicity-based drug rescue; customized drug discovery assays for therapies to treat liver disease and diabetes; and exploratory nonclinical studies for potential regenerative medicine applications involving beta islet cells and other cells of the endoderm lineage.

A biotechnology company, VistaGen Therapeutics is focused on using pluripotent stem cell technology for applications in drug rescue, drug discovery, and regenerative medicine.

For more information, visit: www.vistagen.com

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VistaGen Therapeutics, Inc. (VSTA) Provides Reverse Stock Split FAQs

August 18, 2014

Last week, VistaGen Therapeutics implemented a 1-for-20 reverse split of its common stock. As a result, the number of shares of the company’s common stock outstanding was reduced from approximately 25.5 million to approximately 1.2 million. Because the stock price went up appropriately, the split did not affect any stockholder’s ownership percentage or total market value at the time it was implemented.

The reverse stock split is intended to increase market awareness of VistaGen’s common stock and position the company for potential future listing of its common stock on a national securities exchange. A number of other reasons are listed at the new FAQs page recently posted at www.vistagen.com/?page_id=1372.

To view the original press release announcing the split, visit www.vistagen.com/?p=1366.

For those unfamiliar with the company, VistaGen Therapeutics is a biotechnology company applying stem cell technology for drug rescue and cell therapy. Drug rescue combines human stem cell technology with modern medicinal chemistry to generate new chemical variants of once-promising drug candidates that have been discontinued during late-stage preclinical development due to heart or liver safety concerns. VistaGen also focuses on cell therapy, or regenerative medicine, which includes repairing, replacing or restoring damaged tissues or organs.

More information on the company and its technology can be found at www.vistagen.com

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VistaGen Therapeutics, Inc. (VSTA) Announces New Agreement with Largest Shareholder

July 22, 2014

In an 8-K filed with the SEC today, VistaGen Therapeutics announced that Platinum Long Term Growth VII, LLC, the company’s largest investor, has entered into an Amended and Restated Note Conversion Agreement and Warrant Amendment.

According the SEC filing, Platinum has agreed to convert all senior secured convertible promissory notes currently held into unregistered equity securities upon the consummation on or before August 31, 2014, of either a private equity financing resulting in aggregate gross proceeds of at least $36.0 million, or a registered equity financing resulting in gross proceeds of $10.0 million or more. The deal would significantly improve VistaGen’s balance sheet.

Additionally, pursuant to the terms and conditions of the amendment and consummation of a qualified financing on or before August 31, 2014, the exercise price of all warrants issued by VistaGen to Platinum in connection with the notes, and warrants that still may be issued pursuant to the note exchange and purchase agreement dated October 11, 2012, if any, will be fixed at $0.50 per share or the purchase price of common stock sold in the qualified financing, whichever is lower. Finally, the anti-dilutive provisions contained in the warrants, other than typical adjustments for stock splits, combinations and dividends, will be terminated.

Platinum also agreed to terminate the amended and restated security agreement, intellectual property security and stock pledge agreement and negative covenant agreement, each dated October 11, 2012, related to the Notes, and release all of its security interests in the assets of VistaGen and its subsidiaries in connection with the company’s completion of a Qualified Financing and conversion of the Notes.

To read the whole filing, visit www.dtg.fm/vsta-8k-7-22-14

For more information on VistaGen, visit www.vistagen.com

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Millions in Grant Funding Provide Foundation of Opportunity for VistaGen Therapeutics, Inc. (VSTA)

July 15, 2014

The National Institute of Health aims to supports biomedical science and behavioral research through the pursuit of knowledge of the biology and behavior of living systems and to then apply that knowledge to “extend healthy life and reduce the burdens of illness and disability.” NIH’s own role in this mission includes the provision of funding grants and/or cooperative agreements. To ensure that funds are allocated to organizations aligned with this goal, NIH first determines whether or not the applying company’s project will yield a “sustained, powerful influence on the research field(s) involved.”

Obtaining a grant is much more than a simple petition and business plan. In order for a company to receive a grant from NIH, an applying company’s project must undergo peer review and demonstrate, in addition to other considerations, the following five criteria:

• Significance – address an important problem or critical barrier to progress in the field; Investigators – doctors, collaborators and other researchers must be well-suited, experienced and trained for the project;
• Innovation – the application must challenge and seek to shift current research or clinical practice by utilizing novel concepts, approaches, instrumentation or intervention;
• Approach – appropriately strategized to accomplish the specific aim of the project; and
• Environment – will scientific environment in which the work will be conducted contribute to the probability of success?

The rewards of meeting these criteria are often invaluable. Case in point: VistaGen, Inc., a San Francisco-based stem cell company focused on drug rescue and regenerative medicine backed by a team of stem cell research and development teams and collaborators that for 15 years have focused on controlling the differentiation of pluripotent stem cells to produce multiple types of mature, functional, adult human cells for drug rescue applications.

Since its inception in 1998, the company has received a total of $8.8 million in grant funding from the NIH for phase 1 clinical development of its AV-101 lead small molecule drug candidate.

This funding enabled the company to complete phase 1 development of AV-101, an orally available small molecule prodrug candidate designed to address needs in the multi-billion dollar neurological disease disorders market, such as neuropathic pain, epilepsy and depression. VistaGen has submitted an AV-101 IND application with the U.S. FDA to cover clinical development for neuropathic pain, though the company believes that completed phase 1 AV-101 safety studies will also support development of AV-101 for multiple indications, including epilepsy and depression.

VistaGen’s plan, contingent upon completion of this offering, is to pursue potential opportunities for further development and commercialization of AV-101 on a stand-alone or corporate partnership basis. If successful, the company says it intends to use the net proceeds from such an arrangement to expand its drug rescue and regenerative medicine programs, which are based on its stem cell technology platform, Human Clinical Trials in a Test Tube™.

Receiving NIH funding marked a pivotal moment in VistaGen’s history, providing the company with a monetary avenue to pursue its broader mission to commercialize therapeutically and commercially promising regenerative medicine programs.

For more information, visit www.vistagen.com

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VistaGen Therapeutics, Inc. (VSTA) at Forefront of Stem Cell Technology for Drug Rescue, Regenerative Medicine, Small Molecule Drugs

July 8, 2014

VistaGen Therapeutics stands at the forefront today of the rapidly developing world of stem cell technology, with a tight portfolio of IP that cuts hard and fast across multiple, critical applications in the areas of drug rescue and regenerative medicine. The company’s Human Clinical Trials in a Test Tube™ platform fuses together proprietary technologies for controlled development/differentiation of human pluripotent (having the potential to differentiate into almost any cell) stem cells into many types of mature, functional adult cells and the utilization thereof.

This incredible capacity to produce large quantities of functional adult cells has thus far led to two 3D “micro-organ” bioassay system applications for drug rescue, CardioSafe 3D™ and LiverSafe 3D™. Using stem cell-derived, functional heart and liver cells (respectively) to create mock-up 3D cell networks and tissue structures, which accurately model the actual organs in the body, presents the multibillion dollar pharma development space with a safer small molecule Drug Rescue Variant™ solution pathway. This salvage opportunity technology is able to help drug developers recoup the massive capital outlays associated with creating once-promising new drug candidates that got dropped due to bad drug interactions and/or toxicity concerns, in essence offering drug developers a way to hit the reset switch and come away with a safer, more effective product instead of lost capital. Moreover, CardioSafe 3D and LiverSafe 3D offer pharma developers a drug metabolism and toxicity screening solution that ably surmounts one of the major causes of the high failure rates among otherwise promising drug candidates, the persistent limitations of preclinical drug testing.

VistaGen is also developing a novel, orally available small molecule prodrug candidate known as AV-101, which has shown solid results in Phase 1 clinical development for neuropathic pain in the U.S., under an active Investigational New Drug application with the FDA. With apparent traction in depression and epilepsy, as well as potentially in other neurological conditions, including Parkinson’s, AV-101 is of particular interest in that it acts as a synthetic analog for a naturally-occurring regulatory compound in the central nervous system, kynurenic acid (AV-101 converts into the analog, 7-chlorokynurenic acid, inside the brain). High oral bioavailability, excellent blood-brain barrier transport dynamics and preferential conversion to synthetic kynurenic acid at sites of neural damage, all reinforce the $8.8M in funding VSTA has received from the NIH for AV-101’s development.

Advancements in the broader stem cell space, like the recent announcement that Japanese researchers at the RIKEN Center for Life Science Technologies have identified how CCL2 (a chemokine that plays a role in immune response) functions as a pluripotency enhancer in human induced pluripotent stem cells, makes VSTA’s portfolio start to look more and more interesting. The potential for modeling drug interactions in vitro with high-fidelity in vivo results guidance (long before substantial development costs start to add up), as well as the potential to salvage otherwise deprecated, yet promising drug candidates, combined with an eventual ability to re-grow various tissues and break through to new horizons in regenerative medicine, makes VSTA an exciting company for its size and market cap. Inducing the body to take up cultured stem cells and re-grow blood, bones, cartilage and other tissues, even heart, liver and pancreatic tissue, is serious blue sky potential that may even dwarf the value of chemical variant salvaging on drug candidates for pharmaceutical and biotech customers.

With recent patent expansions in both the U.S. and Canada this year for their stem cell technology platform, VistaGen is feeling supremely confident about the company’s performance. CEO of VSTA, Shawn K. Singh, JD, even noted how the Canadian patent allowance in particular expands the company’s core IP in a key target market the company has been after for years now. This particular patent, under exclusive license from the Icahn School of Medicine, Mount Sinai, New York, covers pluripotent stem cell culture systems which produce endoderm lineage cells, including liver, lung, pancreas, parathyroid, and thyroid cells. The equivalent U.S. patent expansion covers three patents under similar license and roundly reinforces the company’s already strong LiverSafe 3D position, while also opening up collaboration potential in the area of liver biology and drug metabolism assay, as well as regenerative therapy for diabetes using pancreatic beta-islet cells.

The recent (July 2) announcement that University at Buffalo researchers have identified the “master switch” which triggers myelination in the brain, a process where fatty layering (a sign of healthy central nervous system functionality) accumulates on the neuronal axon (or main shaft), allowing the brain cell to transmit data quickly and reliably (enabling more complex brain activity to take place), should give investors some idea of where this sector is heading. The identification of this “master switch,” a transcription factor in human brain cells known as SOX10, puts multiple sclerosis for instance directly in the crosshairs for development of an efficient treatment. An MS treatment based on transplantation of myelin-generating progenitor cells that doesn’t take a year or more, says it all about the potential of the stem cell space really. In this particular case the potential exists for a small molecule drug candidate that could switch on SOX10 as well.

The immense potential of stem cell technology for fundamentally transforming several areas of medicine is fully inherent in companies like VistaGen Therapeutics, whether we are talking small molecule drug development or regenerative stem cell therapies and organ modeling.

More data on VistaGen Therapeutics is available at: www.vistagen.com

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VistaGen Therapeutics, Inc. (VSTA) Drug Rescue Model Resuscitates Failed Drug Candidates

July 1, 2014

VistaGen Therapeutics is focused on drug rescue and regenerative medicine, applying its pluripotent stem cell technology toward the discovery of small molecule drugs and biologics that trigger the endogenous growth and healing processes that enable the human body to repair tissue damage caused by certain degenerative diseases.

For more than 15 years, VistaGen’s research and development teams and collaborators have developed proprietary methods for controlling the differentiation of pluripotent stem cells with a particular focus on human heart and liver cells for the company’s drug rescue programs.

Drug rescue refers to the process of taking small molecule drug candidates that were previously discovered and validated by pharmaceutical companies but were terminated in the development stages due to unexpected heart or liver safety concerns. The playing field here is tremendous – roughly one-third of all potential new drug candidates fail in preclinical or clinical development due to these toxicity concerns, resulting in the loss of millions of dollars in investments and countless hours of research.

For a better idea of how dire these facts are, consider that last year the U.S. pharmaceutical industry pumped more than $51 billion into research and development. Sounds promising, but the FDA’s Center for Drug Evaluation and Research (CDER) only approved 27 novel drugs (NMEs) in 2013. In fact, since 2003, CDER has approved an average of 27 NMEs per year, and on is track to continue the average with 17 approved NMEs thus far in 2014.

Using its proprietary stem cell technology, VistaGen aims to build a diverse drug pipeline of small molecule variants (Drug Rescue Variants), picking up where the pharmaceutical companies left off. Applying its CardioSafe 3D™ and, when validated, LiverSafe 3D™, biological assay systems, VistaGen is in a unique position to produce new Drug Rescue Variants faster and less expensively than entities using conventional animal and in vitro cell culture testing.

These bioassay systems will be used to identify and validate that the Drug Rescue Variant demonstrates an improved efficacy with reduced toxicity compared to the original drug candidate. From here, the company plans to license its lead Drug Rescue Variant, benefiting from economic participation rights, development milestone payments and royalties on commercial sales.

For more information visit www.vistagen.com

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VistaGen Therapeutics, Inc. (VSTA) Employs a Unique Drug Rescue Model

June 23, 2014

VistaGen Therapeutics is a biotechnology company mainly focusing on human pluripotent stem cell (hPSC) technology for drug rescue and regenerative medicine. Human pluripotent cells are the building blocks of all cells of the human body. VistaGen’s versatile stem cell technology platform, “Human Clinical Trials in a Test Tube™,” has been developed to provide clinically relevant predictions of potential heart and liver toxicities of new drug candidates and to enable the company to develop drug rescue variants for once-promising drug candidates. These variants help biotech companies to overcome heart and liver toxicity issues that halted prior clinical trials.

Drug rescue and regenerative is a unique model as VistaGen selects drug candidates that have good future growth prospects but that were abandoned by biotech companies before the approval stage because of their negative effects on the patients’ hearts and livers.

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To create a pipeline of drug rescue variants, VistaGen reworks rejected drug candidates by combining its Human Clinical Trials in a Test Tube platform with contemporary curative chemistry. This will help VistaGen to develop safer drug rescue variants, which will then be sold to biotech companies that will further process and commercialize them. The technology allows the buyer to develop safer drug rescue variants, improve the predictability of a drug’s success or failure, and lower their R&D cost. According to the FDA, 10% improvement in a drug’s failure predictability before commencing its trial studies could save companies around $100 million in R&D costs, helping them to develop new, improved drugs with reduced investment.

Human Clinical Trials in a Test Tube is also expected to achieve faster FDA approval for drug candidates, increasing the biotech company’s bottom line. For developing these variants VistaGen will receive upfront and milestone payments and is eligible for royalties on net sales of these drugs as per their agreement.

Opening doors for future growth

VistaGen with its technological experience designed and developed CardioSafe 3D™, a high throughput, human heart cell-based bioassay. CardioSafe 3D screens heart toxicity in connection with developing drug rescue variants. This will enhance the company’s capability to generate data with its internal validation studies that will allow it to demonstrate more accurate in-vitro prediction of the in-vivo cardiac effects, both toxic and nontoxic, of the new molecules.

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On April 10, VistaGen began collaboration with Cardiac Research Consortium to improve the cardiac safety of medical products as per FDA norms. Along with this the company is also planning to partner with big pharmaceutical and biotechnological companies. VistaGen, with its expertise in developing drug rescue variants, will allow biotech companies to advance their drugs as per FDA norms by improving cardiac safety abilities of new molecules. VistaGen has successfully demonstrated significant development in clinically predictive systems for the preclinical cardiac safety screening of anti-cancer drug candidates with its CardioSafe 3D bioassay. This technology improved the efficacy of new molecules and reduces heart toxicity compared to earlier cancer drugs and other therapeutic compounds. Along with this VistaGen is focusing on developing and validating LiverSafe 3D™, a novel, three-dimensional in-vitro bioassay system that will enable the company to evaluate liver toxicity and drug metabolism issues.

The successful implementation of CardioSafe 3D and Liversafe 3D will allow molecule-developing companies to significantly reduce R&D expenses and earn faster FDA approval. This will in turn strengthen VistaGen financially with an increase in royalties.

Leading its own pain-relieving drug

VistaGen is developing AV-101, a pain reliever drug candidate that it acquired through the acquisition of Artemis Neuroscience in 2003. The company successfully completed phase I development of AV-101 as per the active Investigational New Drug (IND) application filed to FDA for treating neuropathic pain. VistaGen is evaluating the efficacy of this drug in trial studies for treating neuropathic pain, a serious and chronic conditions that causes pain after an injury, and for treating depression, epilepsy, and other neurological conditions. VistaGen’s strategic plans will help it to progress AV-101 to phase II development and enhance its efficacy in treating depression, epilepsy, Huntington’s disease, and Parkinson’s disease. By developing this candidate the company will have greater growth opportunities as neuropathic pain affects around 1.8 million in the U.S. alone. The company has received grants of $8.75 million from the National Institutes of Health (NIH) to develop this drug and receive regulatory approval.

Further, “the safety iceberg model” represents huge underlying opportunities in developing drug rescue variants. VistaGen has a higher future growth opportunity with its hPSC technology, which will enable biotech companies to overcome the weakness related to heart and liver toxicity.

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Conclusion

VistaGen’s hPSC technology platform will enable it to develop drug rescue variants of the promising drug candidate, supporting it financially long-term. Additionally, expanding its product portfolio with AV-101 will support its top line. This unique model developed by the company makes it a good long-term investment.

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VistaGen Therapeutics, Inc. (VSTA) Expands IP Portfolio, Awarded Canadian Patent Coverage

June 16, 2014

VistaGen Therapeutics, a biotech company using proprietary pluripotent stem cell technology for drug rescue and regenerative medicine, has received from the Canadian Intellectual Property Office a Notice of Allowance for Canadian patent No. 2,684,022, entitled “Mesoderm and Definitive Endoderm Cell Populations.”

This patent, which is exclusively licensed to VistaGen by the Icahn School of Medicine at Mount Sinai in New York, will expand VistaGen’s 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. The patent enables the company to extend its research into the Canadian market and follows the company’s recently awarded U.S. patent.

“This important Canadian patent allowance extends our core intellectual property protection in a market that has been strategically significant to us for many years,” Shawn K. Singh, JD, VistaGen’s chief executive officer, stated in the news release. “In a manner similar to our recently announced Notice of Allowance for its counterpart, U.S. Patent Application 12/836,275, this new Canadian patent allowance and our world-class differentiation and assay formulation expertise put us in a strong position to pursue additional stem cell research projects in Canada, especially innovative projects involving liver biology, customized drug metabolism assays, and pilot nonclinical studies using pancreatic beta-islet cells for drug and regenerative cell therapies for diabetes.”

For more information visit http://www.vistagen.com/

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VistaGen Therapeutics, Inc. (VSTA) Stands to Reverse Tremendous Costs of Drug Failure with Pluripotent Stem Cell Technology

June 13, 2014

For 16 years, California-based VistaGen Therapeutics has worked with key collaborators to develop proprietary technologies which produce several types of several types of mature, functional adult human cells for drug rescue application. In its drug rescue model, the company leverages its two biological assay systems, CardioSafe 3D™ and LiverSafe 3D™, and modern medicinal chemistry to generate novel, safer variants of once-promising drug candidates that were terminated due to unexpected heart or liver safety issues.

In laymen’s terms, “drug rescue” refers to research and development efforts that use small molecule drug candidates that had been discovered and validated in medical efficacy tests, but were discontinued due to health safety concerns before they obtained FDA approval. Many of these drug candidates were shelved due to heart- or liver-related concerns.

When a pharmaceutical company develops a new drug candidate, the company often invests a decade-worth of dedicated efforts and millions of dollars in the drug candidate’s discovery, optimization, and validation of its medical potency. When a drug candidate is terminated, that equates to tens of millions of dollars and countless man-hours going down the drain.  Nearly one-third of all drug candidates fail in preclinical or clinical development due to unexpected health safety risks arising during the process.

From years of development, VistaGen Therapeutics has come up with a proprietary stem cell technology platform that it believes may be an answer. The company’s platform, Human Clinical Trials in a Test Tube™, enables drug candidates to be tested for toxicity concerns in their early stages of development, reducing the staggering costs and time invested when a drug candidate fails. Human Clinical Trials in a Test Tube™ consists of VistaGen’s CardioSafe 3D™ and LiverSafe 3D™ systems.

In 2013, the U.S. pharmaceutical industry spent more than $51 billion in drug research and development. With heart and liver safety issues as a Top reason for why many drug candidates are discontinued, VistaGen Therapeutics aims to recapture substantial value from the prior investment by pharmaceutical companies and others in failed drug candidates by reintroducing them to the biomedical space as new, proprietary variants of the original drug candidates.

For more information, visit: http://www.vistagen.com/

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VistaGen, Inc. (VSTA) Aims to Breathe Life into Shelved, High Potential Drug Candidates and Revitalize Drug Development

June 5, 2014

VistaGen Therapeutics is a stem cell company which centers its attention on drug rescue and regenerative medicine – a type of tissue engineering and molecular biology that deals with the process of replacing, engineering or regenerating human cells, to restore or establish normal function. Believing better cells lead to better medicine, the company feels a vital aspect to making these cells is controlling the differentiation of human pluripotent stem cells commonly referred to as, ‘the building blocks’ of all cells within the human body. VSTA’s stem cell R&D teams have focused on controlling the differentiation of pluripotent stem cells for over 15 years to produce multiple types of mature, functional, adult human cells, with emphasis on human heart and liver cells for drug rescue applications.

The company believes a notable number of pharmaceutical companies are experiencing critical R&D productivity issues as evidenced be their low number of FDA-approved products each year. As an example, the U.S. pharmaceutical industry invested over $51 billion in R&D and the Center for Drug Evaluation and Research (CDER) of the FDA approved a total of only thirty-nine (39) novel drugs, known as New Molecular Entities (NMEs). In 2013, CDER approved only twenty-seven (27) NMEs, thirteen (13) of which NME approvals (48%) were received by only five (5) pharmaceutical companies, including Bayer (2), GlaxoSmithKline (4), Johnson & Johnson (3), Roche (2) and Takeda (2).

Despite significant R&D investment levels by the global pharmaceutical industry since 2003, the FDA has only approved an average of twenty-six (26) NME’s annually. The company’s position is that many pharmaceutical companies with established products that are no longer patent protected are also experiencing substantial market pressure from generic competition. As a result of weak R&D productivity, shrinking product pipelines and generic competition, VSTA believes there will continue to be a critical need among pharmaceutical companies to license the new, safer Drug Rescue Variants they are focused on developing.

Pointing to estimates that show about one-third of all potential new drugs candidates fail in their development stages due to unexpected safety concerns, VSTA presents its drug rescue programs as a viable solution which can recapture substantial value from the prior investment by pharmaceutical companies whose research has been paused on the once promising drug candidate due to heart or liver safety concerns.

For more information on the company, visit www.vistagen.com

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VistaGen, Inc. (VSTA) Aims to Breathe Life into Shelved, High Potential Drug Candidates and Revitalize Drug Development

May 30, 2014

VistaGen is a biotech company applying pluripotent stem cell technology for drug rescue and regenerative medicine with a primary focus on heart and liver cells. A pluripotent stem cell, such as an embryonic stem cell, has the potential to differentiate into a variety of other cell types in a body, making it a valuable component in regenerative medicine.

The term “drug rescue” refers to R&D using small molecule drug candidates that were previously discovered and validated in efficacy studies, but that were dropped during development, prior to FDA approval, due to unexpected safety concerns. VistaGen’s mission is to develop a means to predict these toxicity concerns in early development, before the pharmaceutical developer spends considerable time and money on animal or human testing.

For more than 15 years, the company’s stem cell R&D teams have worked alongside key collaborators to develop proprietary methods for facilitating controlled-differentiation of pluripotent stem cells to produce several types of mature, functional adult human cells.

The result of these efforts are the CardioSafe 3D™ and LiverSafe 3D™ in vitro bioassay systems, which form the cornerstone of the company’s Human Clinical Trials in a Test Tube™ platform.

Using mature cardiomyocytes (heart cells) differentiated from human pluripotent stem cells, VistaGen developed its CardioSafe 3D™ to predict toxic and non-toxic in vivo cardiac effects of small molecule drug candidates. LiverSafe 3D™, the company’s second novel stem cell technology-based bioassay system, was developed using mature hepatocytes (liver cells) and was also derived from human pluripotent stem cells.

Unexpected toxicity is one of the top reasons for safety-related drug failure during clinical development. Because VistaGen’s systems use human stem cells rather than animal, cadaver, immortalized or transformed cells, and are three dimensional cultures, its technology more accurately reflects the structures and biology inside the human body, giving it the power yield responses to drug candidates that are more predictive of human drug responses.

VistaGen continues to advance the pharmaceutical applications of stem cell-derived blood, bone, cartilage, heart, liver and pancreatic beta-islet cells, while exploring opportunities to leverage its stem cell technology platform for regenerative medicine purposes.

The company’s goal is to utilize its drug rescue programs to recapture the substantial value invested by pharmaceutical companies and others into once promising drug candidates, and to build a diverse pipeline of new, proprietary small molecule variants of discontinued candidates.

For more information, visit www.vistagen.com

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VistaGen Therapeutics, Inc. (VSTA) Joins HESI Cardiac Safety Committee, Sees Collaborative Benefits

May 22, 2014

VistaGen Therapeutics, a biotechnology company applying pluripotent stem cell technology for drug rescue and regenerative medicine, reports that it is now a member of the Cardiac Safety Technical Committee, Cardiac Stem Cell Working Group, and Proarrhythmia Working Group of the Health and Environmental Sciences Institute (HESI).

Using mature cardiomyocytes (heart cells) differentiated from human pluripotent stem cells, VistaGen developed its CardioSafe 3D™ bioassay system to predict the in vivo cardiac effects, both toxic and non-toxic, of small molecule drug candidates with greater speed and precision than the traditional, surrogate safety models most often used in drug development. The company’s pluripotent stem cell-derived heart cells and CardioSafe 3D are vital components of its Human Clinical Trials in a Test Tube™ platform and drug rescue programs.

Ralph Snodgrass, Ph.D., VistaGen’s president and chief scientific officer commented, “We look forward to collaborating with leading pharmaceutical, biotechnology, academic, and regulatory members of the HESI’s Cardiac Safety Technical Committee, and related working groups, to help advance, among other goals, the FDA’s CIPA initiative, which is focused on developing innovative preclinical systems for cardiac safety assessment during drug development.”

HESI, a global branch of the International Life Sciences Institute (ILSI), boasts a membership roll that includes most of the world’s largest biotechnology and pharmaceutical companies for which it provides an international forum to advance the understanding of scientific issues related to human health, toxicology, risk assessment, and the environment. ILSI is a nonprofit, worldwide organization whose mission is to provide science that improves human health and well-being and safeguards the environment.

Operating from its headquarters in San Francisco, California, VistaGen contends that better cells lead to better medicine and that the key to making better cells is controlling with precision the differentiation of human pluripotent stem cells, which are the base cells of the human body.

For more information on the company visit www.VistaGen.com/

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