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Tigris Pharmaceuticals Signs CRADA with the National Cancer Institute
Date:5/15/2008

BONITA SPRINGS, Fla., May 15 /PRNewswire/ -- Tigris Pharmaceuticals, Inc. announced today the execution of a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to collaborate on clinical and preclinical development of AFP-464, an aminoflavone currently in Phase I development. AFP-464 is converted to metabolites which bind covalently to DNA, resulting in p53 activation and apoptosis.

This is part of a four-year CRADA encompassing multiple Phase I and Phase II clinical studies with correlating translational research of AFP-464 in a variety of tumor types. The goal of this research collaboration is to work together for the successful development of AFP-464 as a safe and effective novel pharmaceutical compound for the treatment of cancer. Under this CRADA, two Phase I studies with AFP-464 are currently enrolling in the United States, sponsored by the NCI, at the Mayo Clinic, Wayne State University, and the University of Maryland. These studies are evaluating AFP-464 in patients with advanced solid tumors. Tigris has also initiated a Phase I program at leading cancer research centers in Belgium and France; this work is not included in the CRADA research. The AFP-464 program is anticipated to move to Phase II development in 2009.

"It will be a privilege to work with the NCI on such a promising therapeutic for patients with cancer," stated Edmundo Muniz, M.D., Ph.D., Chief Executive Officer of Tigris. "This CRADA further solidifies the successful partnership to date between Tigris and the NCI."

About AFP-464

Preclinical studies into AFP-464's mechanism of action have shown that AFP-464 induces CYP1A1/1A2 and CYP1B1 protein expression and is converted to metabolites that are covalently bound to DNA, resulting in phosphorylation of p53 with induction of the p53 downstream target p21(Waf1/Cip1) and apoptosis. AFP-464 has shown a unique pattern of growth inhibitory activity in the NCI's 60 tumor ce
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SOURCE Tigris Pharmaceuticals, Inc.
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