Since its inception in 1998, the U.S. National Institutes of Health (NIH) has awarded biotech small-cap VistaGen Therapeutics with $11.3 million in R&D grants, including $2.3 million to support the company’s development of its Human Clinical Trials in a Test Tube™ platform, and $8.8 million for nonclinical and phase 1 clinical development of AV-101, the company’s lead small molecule drug candidate.
The company has also been awarded approximately $1.0 million of grant funding from the California Institute for Regenerative Medicine (CIRM) pertaining to R&D related to liver cells.
VSTA’s corporate development strategy hinges on strategic collaborations, which provides the company valuable access to cutting-edge expertise at a lower price than it would cost to develop the expertise internally. Ideal third-party collaborators include academic research institutions for stem cell research; CROs, which offer regulatory and drug development expertise; and medicinal chemistry companies that analyze drug rescue candidates and generate drug rescue variants.
Complementary to this strategy, VSTA in 2007 entered into a long-term sponsored stem cell R&D collaboration with University Health Network (UNH), one of the world’s largest research hospitals and an affiliate of world-renowned stem cell research facility, the McEwen Centre for Regenerative Medicine, for which VSTA co-founder Dr. Gordon Keller is the director. VSTA has also established several other strategic collaborations.
Leveraging these grants, collaborations and the expertise of Dr. Keller and his team of scientists, VSTA believes it has emerged as the first stem cell company focused primarily on stem cell technology-based drug rescue. Through a combination of licenses, patents, and trade secret laws, VSTA has secured intellectual property rights to the technology underlying its Human Clinical Trials in a Test Tube™. VSTA currently owns or has licensed 43 issued U.S. patents and 12 U.S. patent applications pertaining to its stem cell technologies.
VSTA says the U.S. pharmaceutical industry is facing a “drug discovery and development crisis,” signaled by the fact that while the pharmaceutical industry invested nearly $49 billion in R&D, a total of only 39 novel drugs were approved by the FDA. The hang-up centers on high costs of drug development and non-approval due to safety issues of the candidates.
VSTA aims to buck this trend by leveraging its human cells derived from its hPSC technology, which it considers superior to major toxicological testing systems that use animal cells and cellular assays based on transformed cell lines and human cadaver cells, which at best only approximate human biology. VSTA believes it can develop better medicine by using its technology to provide clinically relevant biological information about a new drug candidate early in the drug development process, before time and money are spent on clinical trials.
For more information, visit www.vistagen.com
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