MissionIR News - VistaGen Therapeutics Awarded U.S. Stem Cell Technology Patent Covering Methods Used to Test Drug Candidates for Liver Toxicity

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Patent covers all mammalian liver stem cells, including human cells

MissionIR would like to highlight VistaGen Therapeutics, Inc. (OTCBB: VSTA), focused on 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 ("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.

In the company’s news yesterday,

VistaGen Therapeutics announced it has secured a new United States patent covering the company’s proprietary methods used to measure and type the toxic effects produced by drug compounds in liver stem cells.

Test methods included in this new patent, (U.S. Patent 11/445,733), titled “Toxicity Typing Using Liver Stem Cells,” cover all mammalian liver stem cells, including human cells. Liver stem cells used in drug testing can be derived from in vivo tissue or produced from embryonic stem cells (ES) or induced pluripotent stem cells (iPS).

H. Ralph Snodgrass, Ph.D., VistaGen’s President and Chief Scientific Officer, stated, “This patent covers the monitoring of changes in gene expression as an assay for predicting drug toxicities. It is well known that drugs activate and suppress specific genes, and that the changes in gene expression reflect the mechanism of drug toxicities. The specific sets of genes that are affected become a profile of that drug.”

VistaGen’s new patent also covers techniques used to develop a database of gene expression profiles of drugs that have the same type of liver toxicity. Using sophisticated “pattern matching” database tools, drug developers can analyze these related profiles to determine “gene expression signatures” that are common and predictive of drugs that produce specific types of toxicity.

“Without this database capability, a drug’s single gene expression profile could not
be interpreted,” Dr. Snodgrass added. “The ability to use liver stem cells to differentiate drug-dependent gene expression profiles, and to compare those profiles of drugs known to induce toxic liver effects, provides a powerful tool for predicting liver toxicity of new drug candidates, including drug rescue variants.”

Shawn K. Singh, VistaGen’s Chief Executive Officer, commented, “Strong and enforceable intellectual property rights are critical components of our plan to optimize the commercial potential of our Human Clinical Trials in a Test Tube™ platform. This new liver toxicity typing patent further solidifies our growing IP portfolio, and supports the continuing development of LiverSafe 3D™, our human liver cell-based bioassay system, which complements our CardioSafe 3D human heart cell-based bioassay system for heart toxicity.”

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Forward-Looking Statement:

This release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. Risks and uncertainties applicable to the company and its business could cause the company's actual results to differ materially from those indicated in any forward-looking statements.

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