VistaGen Therapeutics, Inc. is a biotechnology company applying stem cell technol¬ogy for drug rescue and cell therapy. Drug rescue combines human stem cell technology with modern medicinal chemistry to generate new chemical variants (“drug rescue variants”) of promising drug candidates that have been discontinued during preclinical development (“put on the shelf”) due to heart or liver safety concerns. The Company also focuses on cell therapy, or regenerative medicine, which includes repairing, replacing or restoring damaged tissues or organs.
VistaGen’s versatile stem cell technology platform, Human Clinical Trials in a Test Tube™, has been developed to provide clinically relevant indications, or predictions, of potential toxicity of new drug candidates before they are ever tested on humans. VistaGen’s human pluripotent stem cell-based bioassays more closely approximate human biology than conventional animal studies and nonclinical in vitro techniques and technologies currently used in drug development.
Using mature heart cells produced from stem cells, VistaGen leveraged its Human Clinical Trials in a Test Tube™ platform to develop CardioSafe 3D™, a three-dimensional bioassay system for predicting the in vivo cardiac effects of new drug candidates before they are tested in humans. The Company now plans to leverage CardioSafe 3D™ to build a pipeline of new, safer, variants of promising drug candidates that have been “put on the shelf” by pharmaceutical companies because of toxicity concerns, despite positive efficacy data signaling their potential therapeutic benefits.
The Company’s lead drug candidate, AV-101, is in Phase I development in the U.S. for treatment of neuropathic pain, a serious and chronic condition causing pain after an injury or disease of the peripheral or central nervous system. Neuropathic pain affects approximately 1.8 million people in the U.S. alone. To date, VistaGen has been awarded over $8.5 million from the NIH for preclinical and clinical development of AV-101.
VistaGen is also developing LiverSafe 3D™, a human liver safety and drug metabolism bioassay system, and is preparing to initiate pilot preclinical development of cell therapy programs focused on autologous bone marrow transplantation and heart, liver and cartilage repair. Each of these development programs is based on the proprietary human pluripotent stem cell differentiation and cell production capabilities of the Company’s Human Clinical Trials in a Test Tube™ platform.
Key Investment Highlights
• Stem Cell Technology Addressing Major Challenge in Drug Development
• Drug Rescue Platform Designed to Recapture Prior Investment in Candidates
• Lead Drug Candidate Advancing in NIH-funded Phase I Clinical Trials
• Experienced Management Team with Decades of Relevant Experience
• Proprietary Technology Designed to Save Millions of Healthcare Dollars
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