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Tigris Pharmaceuticals Signs CRADA with the National Cancer Institute

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 cell line screen, with breast, ovarian, lung and renal lines exhibiting particular sensitivity. In vivo antitumor activity of AFP-464 has been demonstrated in several xenograft studies in mice.

About The National Cancer Institute

The National Cancer Institute (NCI) is a part of the National Institutes of Health (NIH) and was established in 1937 under the National Cancer Act; the federal government's principal agency for cancer research and training. The National Cancer Act of 1971 expanded the responsibilities of the NCI and created the National Cancer Program. The National Cancer Program conducts and supports research, training, health information dissemination and other programs with respect to the cause, diagnosis, prevention and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients.

About Tigris Pharmaceuticals, Inc.

Tigris Pharmaceuticals, Inc. is a privately held biopharmaceutical company that develops therapeutic technologies to treat oncology and other areas of unmet medical need. Tigris' mission is to efficiently move its existing and future technologies through the various stages of clinical development in order to meet patients' needs for safe and effective treatments of human illnesses.


Anne White

Chief Operating Officer

Tigris Pharmaceuticals, Inc.

(239) 444-5400

This news release contains forward-looking statements. Such statements are valid only as of today, and we disclaim any obligation to update this information. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other governmental regulation, our pharmaceutical collaborator's ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, and product pricing and third party reimbursement.

SOURCE Tigris Pharmaceuticals, Inc.
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