November 3, 2015
The first patient has been dosed in a Phase 2A study of its orally available AV-101 in adult patients with treatment-resistant Major Depressive Disorder (MDD). The study is being fully funded by the U.S. National Institutes of Health (NIH).
“We believe that AV-101’s differentiated mechanism of action, oral availability, strong preclinical efficacy and excellent clinical safety profile support AV-101 as a potentially transformative treatment for millions of patients with MDD who are inadequately served by standard antidepressant therapies,” stated Shawn Singh, Chief Executive Officer of VistaGen.
VistaGen Announces First Patient Dosed in NIH-Sponsored Phase 2A Study of Orally Available AV-101 in Major Depressive Disorder
October 7, 2015
Dr. Fava is Director of the Division of Clinical Research of the Massachusetts General Hospital (MGH) Research Institute, Executive Vice Chair, Department of Psychiatry at MGH, and Executive Director of the MGH Clinical Trials Network and Institute (CTNI), as well as Slater Family Professor of Psychiatry at Harvard Medical School.
He co-developed, with Dr. David Schoenfeld, Professor of Biostatistics at the Harvard School of Public Health, a novel, patented clinical trial design which increases the probability of detecting a positive drug response, while markedly reducing sample size requirements for the trial, by reducing the potentially high placebo response sometimes found in depression, and other, clinical trials.
Dr. Maurizio Fava, Internationally Renowned Expert in the Field of Depression, Joins VistaGen’s Clinical and Scientific Advisory Board
September 16, 2015
VistaGen Therapeutics announced that pre-clinical data on its lead pipeline candidate, AV-101 – an orally-available new generation prodrug candidate for Major Depressive Disorder (MDD) and other CNS related indications – will be published in the October 2015 issue of the peer-reviewed, Journal of Pharmacology and Experimental Therapeutics. The article, entitled, The prodrug 4-chlorokynurenine causes ketamine-like antidepressant effects, but not side effects, by NMDA/glycineB-site inhibition, is authored by Zanos, et al.
H Ralph Snodgrass, President and Chief Scientific Officer, stated ““AV-101’s emerging efficacy and safety profile suggest a clear potential to provide fast-acting and long-duration antidepressant effects while bypassing the adverse reactions associated with ketamine treatment – and which therefore limit ketamine’s potential usefulness.”
Favorable Data on VistaGen Therapeutics’ AV-101 for Major Depressive Disorder Published in Peer-reviewed Journal of Pharmacology and Experimental Therapeutics
July 1, 2015
VistaGen Therapeutics has as received clearance from the U.S. Food and Drug Administration (FDA) and the U.S. National Institutes of Health (NIH) to initiate an NIH-funded Phase 2 clinical study of its orally active AV-101 in subjects with treatment-resistant Major Depressive Disorder (MDD) under protocol number 15-M-0151.
The Phase 2 study will be a randomized, double-blind, placebo-controlled, crossover clinical trial conducted at the NIMH and designed to evaluate the efficacy and safety of a single oral dose of AV-101 administered once per day for 14 days to approximately 25 patients with MDD. VistaGen and the NIMH expect to initiate enrollment of subjects in the study in 3Q 2015.
VistaGen Receives FDA and NIH Clearance to Initiate NIH-Funded Phase 2 Study of Orally Active AV-101 in Major Depressive Disorder
February 17, 2015
VistaGen Therapeutics has entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. National Institute of Mental Health (NIMH), part of the U.S. National Institutes of Health (NIH).
Under the CRADA, VistaGen and the NIMH will collaborate on an NIH-sponsored Phase 2 clinical study of AV-101, VistaGen’s orally-active NMDA receptor modulator, in subjects with Major Depressive Disorder (MDD).
VistaGen and NIH Sign Agreement for NIH-Sponsored Phase 2 Study of Orally-Active AV-101 in Major Depressive Disorder
February 5, 2015
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.
“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,” said Shawn Singh, CEO of VistaGen.
Dr. Gerard Sanacora Joins VistaGen’s Clinical and Scientific Advisory Board
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.
Both VistaGen and NIMH look to complete the CRADA next month and both commencing and completing the Phase 2 depression study in 2015.
VistaGen Signs Letter of Intent With National Institute of Mental Health for NIH-Sponsored Phase 2 Clinical Study of AV-101 in Major Depressive Disorder
August 19, 2014
VistaGen announced that the Canadian Intellectual Property Office has issued a Notice of Allowance for Canadian Patent Application No. 2,487,058, entitled “Mesoderm and Definitive Endoderm Cell Populations.”
This patent, which is licensed exclusively to VistaGen by the Icahn School of Medicine at Mount Sinai in New York, will further 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.
VistaGen Receives Notice of Allowance for Canadian Patent Further Expanding Stem Cell Technology Platform
August 13, 2014
VistaGen announced today that will implement a 1-for-20 reverse split of its common stock effective at the opening of trading on August 14, 2014.
The reverse stock split is intended to increase market awareness of the Company’s common stock and position the Company for potential future listing of its common stock on a national securities exchange.
VistaGen Announces Reverse Stock Split
June 16, 2014
VistaGen announced that the Canadian Intellectual Property Office has issued a Notice of Allowance for Canadian patent No. 2,684,022, entitled “Mesoderm and Definitive Endoderm Cell Populations.”
This patent 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.
VistaGen Receives Notice of Allowance for Canadian Patent Expanding Stem Cell Technology Platform
May 22, 2014
VistaGen announced that it has become 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), a global branch of the International Life Sciences Institute (ILSI), whose members include most of the world’s largest pharmaceutical and biotechnology companies.
This patent will extend 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.
VistaGen Joins HESI’s Cardiac Safety Committee and Working Groups
April 23, 2014
VistaGen announced that the United States Patent and Trademark Office has issued a Notice of Allowance for U.S. Patent Application 12/836,275, entitled “Cell populations enriched for endoderm cells.”
This patent will extend 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.
Bottom Line: This patent allowance puts 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.
VistaGen Receives Notice of Allowance for U.S. Patent Expanding Stem Cell Technology Platform for Drug Rescue and Regenerative Medicine
April 10, 2014
VistaGen announced that it has become a member of the Cardiac Safety Research Consortium (CSRC), launched in 2006 through an FDA Critical Path Initiative Memorandum of Understanding with Duke University to support innovative research into the evaluation of cardiac safety of medical products.
“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,” said Ralph Snodgrass, Ph.D., VistaGen’s President and Chief Scientific Officer.
Bottom Line: The new membership broadens VistaGen’s influence and access to relationships that support its focus on improving cardiac safety of new drug therapies.
VistaGen Joins the Cardiac Safety Research Consortium
June 28, 2013
VistaGen announced an update on the status of its strategic financing agreement with Autilion AG.
Under the terms of the parties’ April 2013 agreement, as amended, Autilion AG has committed to invest $36 million in VistaGen in consideration for 72 million shares of restricted VistaGen common stock, at a price of $0.50 per share, in a series of closings ending on or before September 30, 2013.
Bottom Line: The parties have amended their agreement and completed a first closing. As noted previously, the self-placed strategic financing does not include warrants or investment banking fees.
VistaGen Provides Update on $36 Million Strategic Financing Agreement
June 17, 2013
VistaGen announced the presentation of key developments involving its CardioSafe 3D™ and LiverSafe 3D™ bioassay systems in poster presentations at the 11th Annual Meeting of the International Society of Stem Cell Research (ISSCR), the largest forum for stem cell and regenerative medicine professionals from around the world.
“H. Ralph Snodgrass, PhD, VistaGen’s President and Chief Scientific Officer, stated, “For the first time, our technology has caught up with the dreams and visions we had 15 years ago when we founded VistaGen. We now have the type and quality of human cell-based biological assay systems that provide real insight into both the therapeutic and toxic effects of new drug candidates long before they are ever tested in humans.”
Bottom Line: VistaGen’s next-generation biological assays can provide important preclinical human data that will increase the probability of selecting safer and effective therapeutics for clinical development.
VistaGen Therapeutics Presents CardioSafe 3D™ and LiverSafe 3D™ Developments at International Society of Stem Cell Research’s 11th Annual Meeting
May 7, 2013
VistaGen announced that its high-quality, human pluripotent stem cell-derived cardiomyocytes (heart cells) were used by collaboration partner Duke University to grow a revolutionary three-dimensional (3D) human heart muscle. An abstract of the original research article published in Biomaterials, an international journal covering the science and clinical application of biomaterials, is available online.
“VistaGen’s human cardiomyocytes produced engineered cardiac tissues that exhibited structural and functional properties superior to those previously reported,” said Dr. Nenad Bursac, Associate Professor in the Departments of Cardiology and Biomedical Engineering at Duke University. “This is the closest man-made approximation of natural human heart muscle to date.”
Bottom Line: Achieving this capability represents a significant breakthrough in heart cell-based therapies and in testing new medicines for potential heart toxicity and potential therapeutic benefits impacting heart disease.
VistaGen Therapeutics and Duke University Publish Results on Production of Functional 3D Human Heart Tissue
April 10, 2013
Under the terms of a strategic financing agreement, Bergamo Acquisition’s European subsidiary will invest $36 million in VistaGen in consideration for 72 million shares of restricted VistaGen Common Stock at a price of $0.50 per share.
The Company’s self-placed strategic financing does not include warrants or any investment banking fees. The transaction is scheduled to close on or before April 30, 2013. At closing, the shares issued in connection with the strategic financing will represent a majority of the issued and outstanding shares of VistaGen’s Common Stock.
Bottom Line: The proceeds of this investment will accelerate stem cell technology-based drug rescue, predictive toxicology and drug metabolism programs.
VistaGen Announces $36 Million Strategic Financing Agreement
Mar. 12, 2013
VistaGen Therapeutics announced it will present key enhancements to LiverSafe 3D™, its human liver cell-based bioassay system designed to predict liver toxicity and drug metabolism issues, in a poster presentation at the Society of Toxicology’s 52nd Annual Meeting, the world’s premier toxicology conference.
Dr. Kristina Bonham, Senior Scientist, Hepatocyte Biology Project Leader, will present VistaGen’s poster entitled “Selection of CYP3A4+ hESC-derived Hepatocytes for Drug Metabolism and Toxicity Assays,” which will detail the expanded data.
Bottom Line: These data demonstrate that VistaGen has substantially improved LiverSafe 3D™ and now has the potential to identify and purify human hepatocytes with more mature functions, as well as provide a novel assay for drugs that effect CYP3A4 enzyme expression, activity and key drug-drug interactions.
VistaGen Therapeutics to Present Enhancements and Expanded Validation of LiverSafe 3D™ at Society of Toxicology’s 52nd Annual Meeting
Mar. 11, 2013
VistaGen Therapeutics announced it will feature key developments involving CardioSafe 3D™, its pluripotent stem cell-based bioassay system for heart toxicity, in a poster presentation at the Society of Toxicology’s 52nd Annual Meeting, the world’s premier toxicology conference.
Dr. Hai-Qing Xian, Senior Scientist, will present VistaGen’s poster titled “Development of Improved hESC-Based High-Throughput Screening Assays for Cardiotoxicity Assessment,” which will detail a number of expanded functional and electrophysiological results.
Bottom Line: The presented results confirm that VistaGen’s stem cell-based human cardiomyocyte screening systems will provide improved capabilities and resolution for cardiac drug rescue programs.
VistaGen Therapeutics to Present CardioSafe 3D™ Developments at Society of Toxicology’s 52nd Annual Meeting
Mar. 4, 2013
VistaGen Therapeutics announced it has entered a new collaboration agreement with the premier global provider of specialized in vitro products for drug metabolism, drug-drug interaction, and toxicity screening.
Utilizing Celsis’ experience and expertise in in vitro drug metabolism, VistaGen aims to demonstrate the accuracy of its human liver cell platform. In this strategic collaboration Celsis will not only validate VistaGen’s stem cell-derived liver cells in traditional pharmaceutical metabolism assays, but will also determine genetic variations in VistaGen’s pluripotent stem cell lines that are important to drug development.
Bottom Line: The two companies aim to characterize and functionally benchmark VistaGen’s human liver cell platform, LiverSafe 3D™, for studying and predicting human liver drug metabolism.
VistaGen Therapeutics Enters Strategic Collaboration with Celsis to Further Advance LiverSafe 3D™
Feb. 7, 2013
VistaGen Therapeutics announced significant advancements in its stem cell technology licensed from the University Health Network (UHN) that improve the company’s ability to develop new stem cell-based bioassay systems and potentially improved cell therapies for human blood system disorders.
“In collaboration with our long-term strategic partners at UHN, we continue to pioneer stem cell technology that promises to change the way we develop medicine and apply treatment,” stated Shawn K. Singh, CEO of VistaGen. “In addition to creating new capabilities and in vitro assays for drug rescue and predictive toxicology, these advancements open the door to development of new treatments for bone marrow failure, anemia, viral diseases and other conditions that compromise the immune system.”
Bottom Line: These latest developments enable advanced tools for drug rescue and potential cell therapies based on human definitive hematopoietic precursor cells
VistaGen’s Collaborators Identify Definitive Precursor for Adult Blood and the Immune System
Jan. 23, 2013
VistaGen Therapeutics announced the successful completion of its final Phase 1 safety study of AV-101, a novel orally available prodrug candidate being developed for treatment of multiple conditions involving chronic neuropathic pain. The study results indicate that AV-101 is safe and well tolerated, with favorable bioavailability and pharmacokinetics.
“This important confirmation of AV-101’s safety is the final step in our Phase 1 program for AV-101,” said Shawn K. Singh, JD, VistaGen’s Chief Executive Officer. “With $8.8 million of funding from the National Institutes of Health (NIH) and outstanding strategic development and regulatory support from Cato Research Ltd., we have successfully completed the required studies enabling Phase 2 clinical development of AV-101 for multiple large market neurological diseases and conditions.
Bottom Line: Aimed at multi-billion dollar neurological disease and disorders and depression markets, AV-101 is a safe compound with no observed side effects. The primary safety and tolerability endpoints of the Phase 1 program were met.
VistaGen Therapeutics Successfully Completes Final Phase 1 Safety Study of AV-101
Jan. 22, 2013
VistaGen Therapeutics announced that Shawn K. Singh, CEO of VistaGen, will present at Noble Financial Capital Markets’ Ninth Annual Equity Conference. Mr. Singh will discuss VistaGen’s progress and unique opportunities to apply its stem cell technology platform for drug rescue, predictive toxicology and drug metabolism screening.
At the time of the presentation, a live audio and video webcast of Mr. Singh’s presentation and a copy of the presentation materials will be available on VistaGen’s website and Noble Financial’s website. Investors and analysts should register approximately 10 minutes prior to the start of the presentation to ensure timely access.
Bottom Line: Attended by institutional investors from across North America, the Noble Financial Capital Markets Conference gives VistaGen the opportunity to increase its influence in the investment community as well as forge new relationships.
VistaGen Therapeutics to Present at Noble Financial Capital Markets Ninth Annual Equity Conference
Dec. 3, 2012
VistaGen Therapeutics formalized its membership in the Toronto-based industry consortium puposed to support the development of foundational technologies that hasten the commercialization of stem cell-based and biomaterials-based products and therapies. Notable members of the industry consortium include Pfizer, GE Healthcare, and Lonza.
Members of the CCRM consortium benefit from proprietary access to certain licensing opportunities, academic rates on fee-for-service contracts at CCRM and opportunities to participate in large collaborative projects, among other advantages. VistaGen is especially well positioned through its existing relationships with key members.
Bottom Line: VistaGen’s membership in the consortium opens new opportunities to form multi-party collaborations with CCRM and industry leaders, as well as grants access to member-only benefits.
VistaGen Therapeutics Becomes Member of Centre for Commercialization of Regenerative Medicine (CCRM) Consortium
Nov. 13, 2012
VistaGen Therapeutics announced a significant advance in its development of LiverSafe 3D™, a human liver cell-based bioassay system designed to predict liver toxicity and drug metabolism issues in connection with the Company’s drug rescue activities.
Shawn K. Singh, CEO of VistaGen, stated, “As we have done with CardioSafe 3D™, our stem cell-based bioassay system for predictive heart toxicity screening and drug rescue, we are developing LiverSafe 3D™ to change the game in drug development – to generate clinically predictive liver toxicology and liver metabolism data at the front end of the drug development process, long before standard animal and human testing.”
Bottom Line: LiverSafe 3D™, together with optimized culture protocols and without the need for any purification, is now capable of producing differentiated populations of cells containing greater than 70% albumin-positive human hepatocytes (liver cells), and greater than 40% of these hepatocytes express the mature CYP3A4 drug metabolizing enzyme.
VistaGen Therapeutics Enhances Predictive Liver Toxicology and Drug Metabolism Bioassay System – LiverSafe 3D™
Nov. 7, 2012
VistaGen Therapeutics and Duke University announced that results of their collaboration were presented yesterday at the American Heart Association 2012 Scientific Sessions in Los Angeles. The presentation, entitled “Human embryonic stem cell-derived cardiac tissue patch with advanced structure and function,” highlighted the important synergistic interactions of VistaGen’s stem cell-derived human cardiomyocytes (heart cells) and Duke’s tissue engineering and analytical technologies.
“VistaGen’s human cardiomyocytes produced engineered cardiac tissues that exhibited functional properties far superior to those previously reported,” said Dr. Bursac. “These superior properties offer exciting new opportunities to develop novel electrical and mechanical tools to guide and evaluate our tissue engineering design of functional bioartificial muscle for stem cell-based therapies aimed at treating heart disease and injury, as well as cardiac arrhythmias.”
Bottom Line: Joint effort combines complementary expertise at the forefront of cardiac stem cell technology, electrophysiology and tissue engineering.
VistaGen Therapeutics and Duke University Announce Heart Tissue Engineering Progress at American Heart Association 2012 Scientific Sessions
Oct. 16, 2012
VistaGen Therapeutics announced the completion of the previously announced $3.25 million financing commitment with Platinum Long Term Growth VII, LLC (Platinum) and approximately $3.0 million strategic debt restructuring. The combined transactions involve the company’s three largest institutional shareholders and its patent counsel.
Shawn K. Singh, CEO of VistaGen, stated, “Our expectations are set very high. Over the next 12 months, we plan to achieve multiple transformative milestones, both in the lab and in the clinic. This funding provided by Platinum, combined with our strategic equity-based restructuring transactions with Cato Research, Morrison & Foerster and University Health Network, will be instrumental in our success.”
Bottom Line: These transactions represent a tremendous vote of confidence by four of VistaGen’s major stakeholders and position the Company to realize the full measure of its commercial opportunities.
VistaGen Therapeutics Completes $3.25 Million Financing and $3.0 Million Debt Restructuring
Sept. 6, 2012
Platinum Long Term Growth VII, LLC purchases a $750,000 secured convertible promissory note from VistaGen, supplementing its purchase in July 2012 of a similar note in the principal amount of $500,000. The company expects that all amounts due will be rolled into a proposed financing anticipated to result in gross proceeds to VistaGen of at least $3.25 million, including $1.25 million from the two outstanding notes.
VistaGen also announced the strategic restructuring of approximately $2.38 million of long-term indebtedness to Morrison & Foerster LLP (M&F), its intellectual property counsel. The restructuring is expected to result in VistaGen’s issuance of restricted common stock to M&F, at a price of $1.00 per share, as payment for approximately $1.38 million of the principal amount.
Bottom Line: VistaGen’s largest institutional investor and highly-regarded, long-time intellectual property counsel further demonstrate their confidence in VistaGen and its stem cell technology platform.
VistaGen Therapeutics Announces Strategic Financing with Platinum Long Term Growth Fund
May 14, 2012
VistaGen CEO Shawn Singh details several key points that bring the company to its current position in the pharmaceutical industry; notes recent accomplishments; and provides insight on its plans to secure additional capital and take advantage of large market drug rescue opportunities.
VistaGen believes its pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube™, along with several strategic relationships, positions the company to secure additional capital and large market drug rescue opportunities. The company has narrowed its focus to its Top 5 candidates, and plans to launch several relative, key initiatives in the next 18 months.
Bottom Line: VistaGen is confident its goals are reachable with strategic financing. Backed by a portfolio of promising technology and intellectual property, and supported by strategic teams and a specialized focus, the company aims to bring clinically relevant human biology to the front end of the drug development process and create value for shareholders.
VistaGen CEO Issues Update Letter to Stockholders
April 24, 2012
VistaGen has secured a new U.S. patent covering the company’s proprietary techniques used to measure and type the toxic effects produced by drug compounds in liver stem cells. The patent, titled “Toxicity Typing Using Liver Stem Cells,” covers all mammalian liver stem cells, including human cells.
Specifically, the patent covers the method used to monitor changes in a gene expression as an assay to predict drug toxicities, as well as the techniques used to develop a database of gene expression profiles of drugs that have the same type of liver toxicity.
Bottom Line: By securing this new patent, VistaGen strengthens its growing intellectual property (IP) portfolio and emphasizes the vital importance of IP rights as it executes its plan to maximize the commercial potential of its Human Clinical Trials in a Test Tube™ platform. It also supports the development of the company’s LiverSafe3D™.
VistaGen Secures Key U.S. Patent Covering Stem Cell Technology Methods Used to Test Drug Candidates for Liver Toxicity
April 16, 2012
VistaGen Therapeutics has licensed breakthrough stem cell culture technology from the McEwen Centre for Regenerative Medicine located at the University Health Network, to develop hematopoietic precursor stem cells from human pluripotent stem cells, with the goal of developing drug screening and cell therapy applications for human blood system disorders.
Bone marrow-derived hematopoietic stem cells are able to repopulate the blood and immune system when transplanted into patients prepared for bone marrow transplantation. These cells have important potential therapeutic applications for the restoration of healthy blood and immune systems in individuals undergoing transplantation therapies for cancer, organ grafts, HIV infections or for acquired or genetic blood and immune deficiencies.
Bottom Line: UHN technology to further support VistaGen’s drug screening and cell therapy programs for human blood system disorders by dramatically advancing its ability to produce and purify an important blood stem cell precursor.
VistaGen Licenses Breakthrough Stem Cell Culture Technology to Speed Development of Drug Screening and Cell Therapy for Immune System Disorders
March 21, 2012
VistaGen and Vala Sciences, Inc. have formed a partnership to advance current methodologies used to screen new drug candidates. The companies announced their plan to combine VistaGen’s human stem cell-derived cardiomyocytes (the muscle cells of the heart that pump blood throughout the body) with Vala’s novel high-speed kinetic imaging.
Vala will use its Kinetic Image Cytometer platform to demonstrate the advantageous abilities of VistaGen’s cardiomyocytes to screen new drug candidates for possible cardiotoxicity compared to conventional in vitro screening systems and animal models.
Bottom Line: The collaboration supports the core drug rescue application of VistaGen’s Human Clinical Trials in a Test Tube™ platform and reflects the company’s aggressive strategy to generate a pipeline of cardio-safe drug candidates.
VistaGen Therapeutics Enters Strategic Drug Screening Collaboration with Vala Sciences
March 5, 2012
VistaGen enters into a strategic collaboration with Duke University with the goal of exploring potential development of novel, engineered, stem cell-derived cardiac tissues to expand the scope of VistaGen’s drug rescue capabilities focused on heart toxicity.
The research will be led at Duke, by Dr. Nenad Bursac, Associate Professor in the Departments of Cardiology and Biomedical Engineering, and at VistaGen, by Dr. Ralph Snodgrass, President and Chief Scientific Officer.
Bottom Line: The collaboration combines VistaGen’s human stem cell-derived heart cells with cutting-edge technology relating to cardiac electrophysiology and cardiac tissue engineering to significantly expand the approaches VistaGen uses in its Drug Rescue Programs to quantify drug effects on functional human heart tissue.
VistaGen Therapeutics and Duke University Enter Into Strategic Research Collaboration
February 21, 2012
MissionIR’s services have been retained for the development and implementation of a strategic investor relations campaign. MissionIR is known for connecting the investment community with companies that have great potential and a strong dedication to building shareholder value.
The national investor relations consulting firm leverages a network of investor-oriented websites and full suite of investor awareness services to broaden the influence of publicly traded companies for the purpose of enhancing their ability to attract growth capital and improve shareholder value.
Bottom Line: VistaGen aims to further grow its shareholder base and accelerate internal initiatives already in place to bring its stem cell technology platform to the forefront of drug development.
VistaGen Therapeutics Engages MissionIR as Its Investor Relations Advisor
February 14, 2012
VisteGen has identified its initial Top 10 drug rescue candidates and plans to launch two formal drug rescue programs by the end of the second quarter. This identification places the company in position to advance to multiple large market opportunities and reflects its more than 10-year focus and investment in pluripotent stem cell research and development.
Over the last year, VistaGen and a network of strategic partners have identified more than 525 once-promising drug candidates that meet criteria for heart toxicity-focused drug rescue. The company and external drug rescue advisors collaboratively narrowed these candidates to 35 compounds to produce the Top 10 list.
Bottom Line: VistaGen has reached an advanced stage in its business model with the identification of these Top 10 drug rescue candidates and upcoming launch of two drug rescue programs.
VistaGen Updates Pipeline of Stem Cell Technology-Based Drug Rescue Candidates
February 8, 2012
VistaGen has signed a strategic drug rescue agreement with Cato BioVentures and Cato Research to identify, evaluate and develop small-molecule drug candidates that were discontinued in late-stage preclinical development due to heart or liver toxicity. The agreement is an extension of VistaGen’s 25-year relationship with Cato to include right-of-first-offer for potential drug rescue candidates.
The endpoint is to attempt breathing new life into these once-promising drugs, which demonstrated positive efficacy of their potential therapeutic and commercial benefits, by generating a new chemical variants. The agreement aligns both companies with VistaGen’s efforts to identify and quickly and cost effectively develop new drug candidates through the use of its stem cell technology platform.
Bottom Line: Through this expanded agreement with Cato BioVentures and Cato Research, VistaGen increases its drug rescue opportunities and creates a key component to meet growing market demand for effective late-stage preclinical candidates with human heart and liver cells.
VistaGen Therapeutics Increases Its Drug Rescue Opportunities with Right-of-First-Offer Agreement with Cato BioVentures and Cato Research
December 7, 2011
VistaGen and Synterys have entered into a strategic medicinal chemistry services agreement that supports VistaGen’s stem cell technology-based drug rescue initiatives with Synterys’ medicinal chemistry expertise.
VistaGen’s drug rescue activities combine its Human Clinical Trials in a Test Tube™ platform with modern medicinal chemistry to generate new chemical variants. This combination includes previous investment and preclinical development completed by others, as well as the company’s own stem cell technology platform.
Bottom Line: VistaGen’s agreement with Synterys establishes a key relationship that is expected to result in the identification of novel drug rescue opportunities with powerful synergies that will drive the drugs through preclinical development.
VistaGen Therapeutics and Synterys Sign Strategic Medicinal Chemistry Collaboration Agreement for Drug Rescue
December 6, 2011
MissionIR recently interviewed VistaGen CEO Shawn Singh for an insight of the company’s operations. The complete interview is now available online.
Singh gives a brief overview of VistaGen and describes its business model and management team, collaborations, milestones, and plans for 2012.
Bottom Line: For 13 years VistaGen has fully utilized its resources to develop a portfolio of therapeutic technologies. Company CEO Shawn Singh provides the investment community with an inside view of how the company has used these technologies, where the company has been, and where it’s going.
MissionIR Features VistaGen Therapeutics in Exclusive Interview Featuring CEO Shawn Singh
November 17, 2011
VistaGen and the University Health Network (UHN), one of Canada’s largest research hospitals, have amended their collaborative R&D program to extend the agreement through September 2017. The amended UHN agreement includes five key programs that further support VistaGen’s core drug rescue initiatives and potential cell therapy applications.
VistaGen will leverage its unique relationship with Dr. Gordon Keller, head of UHN’s McEwen Centre for Regenerative Medicine in Toronto, which gives VistaGen access to cutting-edge stem cell research and supports the drug rescue capabilities of the company’s Human Clinical Trials in a Test Tube™ platform.
Bottom Line: By extending their alliance, VistaGen and UHN also expand the scope of their collaborative research. VistaGen and UHN scientists will focus on large-scale production of stem cells, enhance current cell production methods, and conduct research to develop stem cell-based drug discovery and drug rescue technologies.
VistaGen Therapeutics and University Health Network (Toronto) Extend Broad Stem Cell Alliance and Expand Scope of Collaborative Research
October 25, 2011
Peer-reviewed journal Nature Biotechnology has published the findings of a recent VistaGen study that identifies a cell surface marker useful in the identification and purification of human pluripotent stem cell-derived cardiomyocytes. The research was funded in part by VistaGen and conducted by a collaborative team led by Dr. Gordon Keller at the University Health Network’s (UHN) McEwen Centre for Regenerative Medicine in Toronto.
Through its research agreement with Dr. Keller, chairman of the VistaGen’s Scientific Advisory Board, and a license agreement with the UHN, VistaGen has exclusive worldwide rights to intellectual property arising from this research conducted by Dr. Keller’s laboratory.
Bottom Line: The identification of this antibody represents a significant step for VistaGen’s bioassay system and cell therapy initiatives, and offers a viable approach for numerous therapeutic applications. It also points to the efficacy of the company’s Human Clinical Trials in a Test Tube™ platform, which has proprietary applications in drug screening, cell therapy and regenerative medicine.
VistaGen Therapeutics Reports Identification of Cell Surface Marker that Permits High-Yield Purification of Human Pluripotent Stem Cell-Derived Cardiomyocytes
October 5, 2011
VistaGen announces a poster presentation of its R&D programs at the fourth Symposium on Cardiovascular Regenerative Medicine hosted by the National Institutes of Health’s (NIH) National Heart, Lung and Blood Institute. The data demonstrate the advantages of VistaGen’s human stem cell-derived “Micro-Heart” cardiotoxicity bioassay system.
The poster describes work conducted by VistaGen’s scientists in collaboration with scientists at ChanTest Corporation in Cleveland, Capsant Neurotechnologies in Southampton, UK, and the laboratory of Dr. Gordon Keller at the University Health Network’s McEwen Centre for Regenerative Medicine in Toronto.
Bottom Line: This work demonstrates the applicability of VistaGen’s Human Clinical Trials in a Test Tube™ platform for preclinical cardiac safety screening, and represents another step in the company’s mission to demonstrate the clinical relevance and power of its platform.
VistaGen Therapeutics Presents Highlights of its Human Stem Cell-Derived “Micro-Heart” Cardiotoxicity Assay at NIH Symposium on Cardiovascular Regenerative Medicine
September 28, 2011
VistaGen adds two additional U.S. patents to its intellectual portfolio, supporting its therapeutic and drug discovery programs. The awarding of these two patents provides additional protection for the company’s proprietary research and development activities.
The patents stem from work conducted by scientists in the laboratory of Dr. Gordon Keller, director of the University Health Network’s McEwen Centre for Regenerative Medicine in Toronto and chairman of VistaGen’s Scientific Advisory Board.
Bottom Line: These patents expand the application of VistaGen’s pluripotent stem cell differentiation technology and highlight the company’s leadership position in the field as it applies its Human Clinical Trials in a Test Tube™ platform for proprietary applications in drug rescue, cell therapy and regenerative medicine.
VistaGen Therapeutics Expands Key Stem Cell Technology Patent Estate Supporting its Drug Rescue and Cell Therapy Programs
September 26, 2011
VistaGen announces the publication of original research, which demonstrates the use of pluripotent stem cells to generate insulin in mice. The research stems from collaborative research between VistaGen and the laboratories of Dr. Gordon Keller at the University Health Network’s McEwen Centre for Regenerative Medicine in Toronto and Dr. Atsushi Kubo at Nara Medical University in Japan.
The studies are part of VistaGen’s Human Clinical Trials in a Test Tube™ platform, which has proprietary applications in drug screening, cell therapy and regenerative medicine in the areas of metabolic disease and diabetes. The published results are the product of international collaboration initiated and led by VistaGen scientists in the United States.
Bottom Line: The published studies suggest direction for future development of VistaGen’s research, and provide support to the company’s efforts to produce fully functional human beta-islet cells for drug discovery and clinical applications. The results also mark a significant milestone as the company advances toward its goal of developing superior biological systems for drug development.
VistaGen Therapeutics Reports Advances in its Pancreatic Cell and Regenerative Medicine Programs
September 14, 2011
VistaGen updated shareholders of its strategic plan to develop and commercialize its technology platform and lead small molecule CNS drug candidate. The company is targeting three large market opportunities to leverage its stem cell technology system, Human Clinical Trials in a Test Tube™; its CNS drug development efforts are focused on clinical studies of AV-101 for neuropathic pain.
The company highlighted the goals and developments of its Human Clinical Trials in a Test Tube™ and CardioSafe 3D™platforms; drug rescue activities and the development of a second bioassay system, LiverSafe3D™; collaborative research initiatives and cell therapy programs coordinated with Dr. Gordon Keller in Toronto; and plans to begin the second phase 1b clinical study of AV-101 for the treatment of neuropathic pain, for which the company has been awarded more than $8.5 million to develop.
Bottom Line: VistaGen has successfully established various strategic collaborations, investments and grant awards to advance its cutting-edge technology and expand its therapeutic potential and application. The company has established a plan of action to continue its progress to develop a diverse pipeline of drug rescue variants.
VistaGen Therapeutics Provides Investor Update On Corporate Activities and Upcoming Initiatives
May 17, 2011
Through a strategic merger with Excaliber Enterprises, VistaGen is now trading on the public markets, operating as a wholly owned subsidiary of Excaliber. Excaliber plans to change its name to VistaGen Therapeutics Inc. and will receive a new ticker symbol on the OTCBB upon completion.
Excaliber will continue VistaGen’s focus to develop and commercialize applications of its stem cell technology platform. The company’s immediate goals are to leverage its CardioSafe 3D™ technology to monetize a pipeline of drug candidates; expand its drug rescue capabilities through LiverSafe3D™; and advance pilot preclinical therapy programs of its Human Clinical Trials in a Test Tube™ platform.
Bottom Line: VistaGen’s position as a public company through strategic merger, paired with its recent success in raising capital, provides the company with further opportunity to advance their core programs.
VistaGen Therapeutics and Excaliber Enterprises Announce Completion of Reverse Merger and $3.8 Million Financing
January 12, 2011
VistaGen and NuPotential Inc. have received a $500,000 grant from the National Heart, Lung and Blood Institute of the U.S. National Institutes of Health (NIH) to accelerate the development of novel and safer approaches in regenerative medicine, drug discovery and drug rescue.
The NIH grant supports the development of NuPotential’s stem cell programming processes as well as VistaGen’s differentiation protocols and processes focused on regenerative medicine applications. The companies will focus on generating patient-specific induced pluripotent stem (iPS) cells by combining their technologies.
Bottom Line: The NuPotential/VistaGen collaboration provides both companies the opportunity to advance their leading-edge stem cell technology. The iPS cells produced through NuPotential’s safer reprogramming processes will play a key role in VistaGen’s regenerative medicine initiatives, and offers advantages in drug discovery and drug rescue applications of VistaGen’s Human Clinical Trials in a Test Tube™ platform.
VistaGen Therapeutics and NuPotential Receives NIH Grant to Develop Safer Approaches for Producing Patient-specific Induced Pluripotent Stem Cells
December 22, 2010
VistaGen completed its initial phase 1 safety study of AV-101, the company’s novel orally available prodrug candidate for treatment of neuropathic pain. AV-101 was well-tolerated by all subjects and did not cause any serious adverse events.
VistaGen’s current AV-101 IND application covers clinical development for neuropathic pain. The company expects to complete the second AV-101 phase 1 safety study during the first quarter of 2011. VistaGen expects its AV-101 phase 1 clinical program to support the development of the drug candidate for neurological disorders, such as epilepsy, and neurodegenerative diseases, such as Huntington’s and Parkinson’s.
Bottom Line: This initial safety study represents an important first step toward VistaGen’s development of AV-101 for several large market neurological diseases and disorders, extending its application to include epilepsy, Huntington’s disease and Parkinson’s disease.
VistaGen Therapeutics Announces Successful Completion of Initial Phase 1 Safety Study of AV-101 for Neuropathic Pain
August 20, 2009
VistaGen announces Shawn K. Singh as the company’s new CEO, where he will lead efforts to realize the full commercial potential of VistaGen’s stem cell technologies. Singh’s role supports founder and former VistaGen CEO Ralph Snodgrass by enabling Snodgrass to focus on strategic development and collaborations. Snodgrass will continue to serve as VistaGen president and chief scientific officer.
Singh’s previous endeavors include his role as managing principal of Cato BioVentures, one of VistaGen’s largest institutional investors; part-time president of VistaGen; chief business officer, president, CEO or chairman of five different biopharmaceutical companies; as well as CBO and general counsel of Cato Research Ltd.
Bottom Line: As VistaGen moves forward on several business fronts, changing the landscape of its corporate guidance strengthens the company’s efforts to accomplish its commercial and scientific goals.
VistaGen Appoints Industry Veteran Shawn Singh as Chief Executive Officer
January 15, 2009
VistaGen and Capsant have signed a strategic commercialization agreement under which the companies will integrate their leading- edge stem cell biology and 3D cell culture platforms to provide next-generation drug development tools for the pharmaceutical industry.
Collaborative efforts will combine VistaGen’s “Clinical Trials in a Test Tube”™ platform with Capsant’s world class OrganDot 3D™ technology to deliver innovative applications for drug development. This will enable the companies to provide their partners with reproducible, mature and functional human cells that grow as 3D ‘micro organs’ in a commercially scalable platform.
Bottom Line: By combining their technologies, the companies have a solid platform that will enable them to move toward enhancing the pharmaceutical industry’s ability to address some of the world’s most challenging diseases and conditions.
VistaGen and Capsant Sign Strategic Stem Cell Technology Commercialization Agreement
December 18, 2008
VistaGen and the non-profit Wisconsin Alumni Research Foundation (WARF) have signed a licensing agreement for human embryonic stem (ES) cell patents pertaining to the development and commercialization of stem cell-based research tools. The license provides VistaGen with strong support of its commercial programs, R&D services, discovery collaborations and enabling licenses.
The licensed patents result from the research of stem cell pioneer Dr. James Thompson of the University of Wisconsin Stem Cell & Regenerative Medicine Center and director of regenerative biology at the new Morgridge Institute for Research. The agreement is reflective of WARF’s ongoing support of advancements and growth in the human ES cell industry, and demonstrates a broader, strong commercial interest in human ES cells.
Bottom Line: VistaGen’s licensing agreement with WARF represents a critical step in the Company’s strategy to become a “one-stop-shop” for the world’s premier stem cell differentiation systems. It also underscores the VistaGen’s expertise in human ES stem cell biology for predictive toxicology, drug discovery screening and drug development.
VistaGen and WARF Sign License Agreement for Human Embryonic Stem Cell Technology
December 16, 2008
The California Institute for Regenerative Medicine (CIRM), the State’s stem cell agency, awarded a nearly $1 million grant to VistaGen in support of the Company’s efforts to expand ongoing development and commercialization of its leading-edge stem cell-based technologies. VistaGen is among the first group of for-profit stem cell companies to receive CIRM funding as part of the Institute’s new “Tools and Technologies” research and development program.
CIRM’s Tools and Technologies Awards are designated for the support of research that either creates new reagents and methods for stem cell research, or for work that enhances existing technologies. The Institute’s overall mission is to accelerate the development of critical therapies for patients with chronic diseases or injury.
Bottom Line: This major grant demonstrates CRIM’s support of VistaGen’s leading stem cell initiatives, and will allow the Company to expand its core stem cell technologies specifically for producing human liver cells into more advanced biological research tools, which in turn could enable the pharmaceutical industry to identify and develop safer drugs more efficiently.
VistaGen Receives Significant Stem Cell Tools and Technologies Grant from California Institute for Regenerative Medicine
October 16, 2008
VistaGen scientists working in collaboration with a research team led by one of the world’s leading stem cell scientists, Dr. Gordon Keller, successfully identified key biochemical pathways involved in directing embryonic stem (ES) cells to become heart cells. The research was published in the online edition of the scientific journal Nature Biotechnology, which noted that by coordinating the signaling of certain molecular pathways, scientists can produce functional, pure heart cells for improved drug safety screening and development.
For more than 10 years, VistaGen has worked with Dr. Keller, director of the Toronto University’s Health Network, the McEwen Centre for Regenerative Medicine. Through this collaborative study, VistaGen and Dr. Keller better understand the development of heart cells, which helps them improve approaches to direct ES cells to become heart cells.
Bottom Line: VistaGen’s research alliance with Dr. Gordon Keller has led to significant findings in the pursuit to better understand stem cell therapeutics. Their joint findings strengthen efforts toward the commercialization of human ES cell technologies as next-generation tools for drug discovery and development in the pharmaceutical industry.
VistaGen Team Pinpoints Key Biochemical Pathways Involved in Generating ES cell-derived Heart Cells
June 17, 2008
VistaGen was awarded patent protection for its embryonic stem (ES) cell-derived pluripotent precursor cells, giving the Company the exclusive rights for commercial applications of its ES cell-based tools developed in alliance with Dr. Gordon Keller. The newly issued U.S. patent is titled “Cell Population and Methods of Production Thereof.”
The patent covers broad composition of matter claims protecting VistaGen’s ES cell tools and assays for drug discovery and development, which are crucial for the in vitro applications of the Company’s drug discovery and screening tools. In addition, the patent claims are expected to add value to the development and ex-vivo expansion of cells for cell therapy companies.
Bottom Line: VistaGen and Dr. Gordon Keller have an extensive research alliance in which the two parties work to develop and perfect the commercial applications of this novel ES cell-derived method. Receiving patent protection for these tools represents a significant advance in VistaGen’s strategy to become a “one-stop-shop” for the world’s premier stem cell differentiation systems.
New Broad Composition of Matter Patent Protects VistaGen’s ES Cell Applications
May 22, 2008
Under a collaborative agreement between VistaGen and Japan-based international pharmaceutical company Sanwa Kagaku Kenkyusho Co. Ltd. (Sanwa), Sanwa selected to license three customized ES Cell-based beta-islet differentiation assay systems, which the company will use to identify and screen new diabetes drug candidates.
The results of several discoveries stemming from the companies’ joint studies are now being evaluated as potential candidates for joint drug development programs. The studies utilized VistaGen’s proprietary technology and bioinformatics software tools to analyze the growth and differentiation of stem-cell derived beta-islet cells.
Bottom Line: The assay systems were designed to expand the capabilities of VistaGen’s ES Cell technologies and to accelerate Sanwa’s discovery and screening programs. The licensing of these three essay systems reflects the need for relevant, efficient and high-quality drug screening, and demonstrates VistaGen’s foothold as a viable leader to meet this need.
VistaGen Licenses Customized Stem Cell-Based Drug Discovery Assays to Sanwa, a Japanese Pharmaceutical Company
April 23, 2008
VistaGen scientists joined a team of leading medical researchers led by world renowned Dr. Gordon Keller to utilize embryonic stem (ES) cells differentiation cultures to identify, grow and study the cells destined to form the human heart. In the future, these cells may be effective in developing new strategies for repairing damaged hearts following a heart attack.
The identification of this cardiac stem cell offers researchers a more detailed insight to heart development. VistaGen will continue to leverage the ES cell biology expertise of Dr. Keller’s group, and expects to apply the results of this research to strengthen the development of commercial applications of ES cell-derived cardiomyocytes in drug screening and predictive toxicology assays.
Bottom Line: Through joint-research and the identification of the cardiac stem cell, VistaGen is on the cutting-edge of generating and validating functional human heart cells of valuable scale and purity, which are necessary for its pharmaceutical discovery applications.
VistaGen Collaborates with Canadian, U.S., and British Researchers ToIsolate Earliest Embryonic Stem Cell-Derived Human Cardiac Cell
March 12, 2008
VistaGen has formed a strategic collaborative ES cell research alliance with Toronto’s University Health Network (UHN), Canada’s leading research hospital, and its stem cell research affiliate, the McEwen Centre for Regenerative Medicine.
Through the alliance, VistaGen plans to utilize the ES stem cell biology expertise and technologies of globally recognized stem cell researcher Dr. Gordon Keller. VistaGen and Dr. Keller will research the advanced techniques to differentiate ES cells into various other cells, ultimately enhancing VistaGen’s in vitro biological systems.
Bottom Line: The collaboration dramatically expands VistaGen’s ES cell research and development programs, and provides the company with tools to accelerate the discovery and development of next generation stem cell technologies.
VistaGen Therapeutics Announces Broad Stem Cell R&D Alliance With Toronto’s University Health Network and The McEwen Centre For Regenerative Medicine
November 23, 2007
A discovery reported by James A. Thomson, the University of Wisconsin researcher who originally extracted stem cells from human embryos, and by Shinya Yamanaka of Kyoto University, shows that adult skin cells can be reprogrammed to mimic embryonic stem cells by adding four genes.
The discovery is a huge advancement for the biopharmaceutical industry since these reprogrammable cells can be turned into any of the 220 cell types that comprise the human body, which opens the door for significant developments in stem cell therapeutics.
Bottom Line: As an aggressive biotechnology player, VistaGen is positioned to benefit from this industry altering discovery, which will provide VistaGen with greater efficacy in its focus to develop drugs for a genetically diverse patient population.
VistaGen Sees Promise for Stem Cell ‘Breakthrough’ to Accelerate Drug Discovery and Development
November 12, 2007
Preclinical data suggest that AV-101, VistaGen’s lead drug candidate for treatment of neurological disorders, may be applicable for the treatment of Parkinson’s disease. Data from the studies, conducted by VistaGen and collaborators in Dr. Sophie Erhardt’s laboratory at the Karolinska Institute in Sweden, were published in the peer-reviewed Journal of Neuropharmacology.
The company reported that in animal studies, treatment of first-in-class prodrug AV-101 was found to increase two key indicators of DA neuron function associated with dopamine production. Since reduced production of dopamine is characteristic of Parkinson’s disease, AV-101’s ability to increase production is a significant value. In addition, preliminary data suggest that AV-101 may be the first drug to activate additional quiescent DA neurons.
Bottom Line: The company is on track to submit an IND to the FDA for the clinical development of AV-101 for the treatment of neuropathic pain and epilepsy. Through the significant findings and publications of the latest study results, the company hopes to extend its clinical studies to also include Parkinson’s disease.
VistaGen Publishes Preclinical Data Supporting the Therapeutic Potential of AV-101 for Parkinson’s Disease — Company’s Lead Compound Can Stimulate Dopaminergic Neuron Activity —
November 6, 2007
VistaGen Therapeutics received $1.2 million in funding from the National Institutes of Health (NIH) to support the filing of the company’s AV-101 Investigational New Drug application with the U.S. FDA in early 2008.
The funding marks the final phase of a $4.3 million grant from the National Institute of Neurological Disorders and Stroke, reflecting its support of VistaGen’s preclinical development of AV-101 for treatment of neuropathic pain, Parkinson’s disease and epilepsy.
Bottom Line: VistaGen’s ability to secure and maintain financial support is a reflection of its successful efforts to meet the milestones needed to move AV-101 toward clinical trials. It also allows the company to secure a foothold in the multi-billion dollar neurological disorders market.
VistaGen Awarded $1.2 Million from NIH for Development of AV-101 for Neuropathic Pain, Parkinson’s Disease and Epilepsy
January 30, 2007
VistaGen Therapeutics achieved positive results from preclinical studies of its lead drug candidate AV-101 in acute and chronic neuropathic pain animal models. The studies suggest that AV-101 has the potential to treat pain caused by nerve damage associated with diabetes, viral infections, injuries and cancer, without adverse sedative or motor effects associated with current treatment.
The company’s studies are supported by a division of the U.S. National Institutes of Health, which has contributed more than $4 million in grants to the company to develop AV-101, and demonstrate another significant therapeutic opportunity for AV-101.
Bottom Line: VistaGen believes AV-101 trumps comparable Pfizer’s blockbuster drug Nerurontin® for epilepsy, demonstrating similar efficacy without the side effects.
VistaGen’s AV-101 Drug Candidate Yields Positive Preclinical Data for Neuropathic Pain Applications– IND to be Submitted to FDA in 2007 —
December 21, 2006
Three recent publications in Nature Biotechnology, Proceeding of the National Academy of Sciences, and Developmental Cell highlighted embryonic stem cells advances that resulted from the research of Dr. Gordon Keller, a highly regarded international stem cell scientist, director of the McEwen Center for Regenerative Medicine in Toronto, and chairman of VistaGen’s Scientific Advisory Board.
These significant advancements expand the understanding of embryonic stem cells and how to generate large populations of cells that have functional properties of liver and heart cells. The research and subsequent advances also allow for new opportunities for drug discovery in diabetes.
Bottom Line: VistaGen’s collaborative efforts with Dr. Keller pave the way for better understanding of stem cell applications and support new approaches for drug discovery and development.
VistaGen Therapeutics Announces 3 Significant Publications Supporting the Use of Embryonic Stem Cells for Drug Discovery and Development
December 7, 2006
Positive preclinical data proposes that VistaGen Therapeutics’ AV-101 may have potential for expanded applications, including for the treatment of symptoms of Parkinson’s disease and schizophrenia.
Studies performed at the Karolinska Institute in Sweden show that AV-101 has unparalleled dual activity capabilities, which may enable VistaGen to expand its Investigational New Drug application to the FDA to cover additional indications.
Bottom Line: AV-101 preclinical data suggest the first in-class prodrug has the potential to treat symptoms of Parkinson’s disease and schizophrenia, which would enable VistaGen to tap into the respective multi-billion dollar markets as it expands therapeutic applications.
VistaGen Therapeutics Announces Positive AV-101 Preclinical Data Suggesting Potential for Parkinson’s Disease
November 30, 2006
VistaGen Therapeutics renewed its strategic partnership with Sanwa Kagaku Kenkyusho Co. Ltd., the most profitable international pharmaceutical wholesaler in Japan. Under the agreement, Sanwa will use VistaGen’s customized, proprietary stem cell-based assays to screen its compound libraries for new drug candidates for treatment of both Type 1 and Type 2 diabetes.
VistaGen and Sanwa will co-develop joint discoveries coming from VistaGen’s stem cell technologies. VistaGen will retain commercial rights for certain new drug candidates and intellectual property developed during the collaboration; Sanwa will receive additional funded research and milestone payments, as well as royalties on product sales.
Bottom Line: VistaGen’s partnership with Sanwa marks the first collaborative pharmaceutical application of embryonic stem cells for the discovery of novel therapeutic treatment of diabetes.
VistaGen Therapeutics and Sanwa Renew Embryonic Stem Cell Drug Discovery and Development Partnership Focused on New Diabetes Treatments
March 23, 2006
VistaGen has inked a strategic business development agreement with Cato BioVentures in which VistaGen obtains the exclusive rights of first negotiation to all CNS product opportunities identified or acquired by Cato BioVentures and Cato Research.
Per the agreement, Cato will leverage VistaGen’s CNS focus and stem cell-based drug technology to expand its CNS product acquisition and investment activities. VistaGen will gain access to Cato’s numerous CNS product acquisition and development opportunities through its relationships with academic institutions, and biotechnology and pharmaceutical companies around the world.
Bottom Line: The mutually advantageous agreement provides VistaGen with access to Cato’s broad range of business development capabilities as well as the opportunity to expand its CNS product candidates.
VistaGen Therapeutics and CATO BioVentures Sign Strategic Business Development Agreement for CNS Products
August 23, 2005
Congressman Tom Lantos (D-San Francisco) voiced his support of the expansion of embryonic stem cell research, and applauded VistaGen employees and investors for their efforts in stem cell research.
“VistaGen is a promising venture-stage biopharmaceutical company … The work being done in the labs here could help bring the world new drugs for treating diabetes and disorders of the central nervous system,” Lantos stated.
Bottom Line: VistaGen was founded on a vision that the world would recognize the potential of stem cells as a superior means of discovering and developing new therapies for some of the world’s most devastating diseases. With the support of Congressman Lantos and the potential increase in federal funding for embryonic stem cell research, VistaGen is positioned to develop and expand its technologies to achieve that vision.
Lantos Affirms Support of Expanded Stem Cell Research–Applauds Commitment by VistaGen Employees and Investors
August 11, 2005
The High Q Foundation has agreed to support VistaGen’s preclinical efficacy studies of AV-101 for the treatment of Huntington’s disease (HD), emphasizing the expansion of the drug candidate’s potential applications.
VistaGen will work with Robert Schwarcz, PhD, a professor of psychiatry, pharmacology and pediatrics at the University of Maryland School of Medicine, to evaluate AV-101’s therapeutic potential in animal models of HD.
Bottom Line: High Q’s support enables VistaGen to further its studies of AV-101 for the treatment of cognitive and motor decline associated with neurological degenerative diseases. It also positions the company to potentially add a third large indication for AV-101.
VistaGen Therapeutics Secures Development Support for New Drug Candidate for Huntington’s Disease
July 12, 2005
VistaGen has received a $197,000 grant from the National Institute of Drug Abuse (NIDA), a division of the U.S. National Institutes of Health (NIH), marking the third grant for AV-101, the company’s lead drug candidate. The newest grant enables VistaGen to complete preclinical efficacy studies for AV-101 as a potential therapeutic for treating pain caused by nerve damage associated with diabetes, viral infections, injuries and cancer.
The NIH also recently awarded VistaGen a grant of $3.7 million to complete all preclinical development for AV-101 for epilepsy. The grant funding is expected to enable submission of an FDA Investigational New Drug Application (IND) for the clinical development of AV-101 for both epilepsy and neuropathic pain.
Bottom Line: This newest grant will leverage VistaGen’s development efforts and resources to advance AV-101 to clinical trials. The grant is a reflection that NIH’s external panel of CNS experts recognizes AV-101′s potential therapeutic benefits.
VistaGen Therapeutics Awarded $197,000 NIH Grant for Expanded Preclinical Development of New Drug Candidate for Neuropathic Pain
May 24, 2005
VistaGen received a $3.7 million grant from the National Institute of Neurologic Disorders and Stroke (NINDS), a division of the U.S. National Institutes of Health (NIH). This is the company’s second grant from the NIH, which will enable the company to move rapidly toward clinical trials of its lead drug candidate AV-101 for the treatment of epilepsy.
Titled “Preclinical Development of 4-Cl-KYN to Treat Epilepsy,” the grant also supports submission of an Investigational New Drug Application (IND) to the FDA for clinical development of AV-101.
Bottom Line: VistaGen believes AV-101 will be of substantial value to the anti-epileptic drug marketplace based on its improved efficacy and decreased side effects. The NIH’s support of VistaGen’s AV-101 is an integral vehicle to move the company toward realizing this potential.
VistaGen Therapeutics Awarded $3,700,000 NIH Drug Development Grant for Lead Epilepsy Drug Candidate