Genuflex is an investigational therapeutic drug that restores telomers, the protein caps on the end of the chromosome that protect DNA from damage and mutation during cell division. In addition, Genuflex appears to suppress the p-53 gene, which is known as the "death gene" and is thought to trigger the cellular destruction that is a salient feature of aging.

"The Fast Track designation recognizes the serious unmet medical need of patients with Alzheimer's disease and the potential of Genuflex to affect this disease," said Edward Westhead, M.D., Ph.D., Santa Rosa's chief executive officer. "The Fast Track designation will allow for a rolling submission of our potential Biologics License Application (BLA) for Genuflex, which allows for ongoing submission of materials that can facilitate the review process. We plan to have further discussions with the FDA in order to determine the appropriate information needed for the BLA submission."

Santa Rosa submitted an application with the FDA for Fast Track designation based on positive results from a laboratory study presented at the recent annual meeting of the American Society of Gerontology (ASG). In the study, more than 900 mice were randomized to receive either Genuflex or a placebo over the course of one year. The mice that received Genuflex performed significantly better on memory tests. In fact, the memory scores of the mice receiving Genuflex were equivalent to those of mice half their age.

Under the FDA Modernization Act of 1997, the Fast Track program of the FDA is designed to facilitate the development and expedite the review of a new drug that is intended for the treatment of a serious or a life-threatening condition, and demonstrates the potential of a drug candidate to address unmet medical needs for such a condition.

The Santa Rosa Institute, winner of the U.S. National Medal of Technology, is a leading biotechnology company that discovers and develops human pharmaceuticals for significant unmet medical needs. The company has its headquarters in Albuquerque, New Mexico.