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FDA Accepts Investigational New Drug (IND) Application for Tigris Pharmaceutical's GGTI-2418

BONITA SPRINGS, Fla., March 4 /PRNewswire/ -- Tigris Pharmaceuticals, Inc., a privately held drug development company, today announced that its Investigational New Drug (IND) application for the Company's geranylgeranyltransferase inhibitor (GGTI-2418) has been accepted by the U.S. Food and Drug Administration. This will allow the company to open a Phase I study evaluating the safety of GGTI-2418 during the first quarter of 2009. GGTI-2418 is a synthetic peptidomimetic inhibitor of geranylgeranyltransferase I (GGTase I) that induces apoptosis by downregulating several pivotal oncogenic and tumor survival pathways.

"We are excited to reach this important corporate milestone and to advance this novel, targeted compound into the clinic," stated Edmundo Muniz, M.D., Ph.D., President and Chief Executive Officer of Tigris. "We look forward to completing the Phase I study of GGTI-2418 in two top Phase I cancer research centers and to continuing our rapid development of this first-in-class agent. This is the first geranylgeranyltransferase inhibitor to move to clinical phase studies."

Tigris in-licensed the exclusive worldwide rights to GGTI-2418 from Yale University and the University of South Florida.

About GGTI-2418

GGTI-2418 is a synthetic peptidomimetic inhibitor of GGTase I that appears to induce apoptosis by downregulating several pivotal oncogenic and tumor survival pathways. GGTase I catalyzes the lipid posttranslational modification which is required for the function of Rho GTPases (frequently found aberrantly activated in human cancer). GGTase I inhibitors block Rho function in cancer cells and induce a G1 phase cell cycle arrest by a mechanism involving induction of the CDK inhibitors p21waf and p27kip, CDK2 and CDK4 inhibition and hypophoshorylation of the tumor suppressor Rb. GGTase I inhibitors also induce apoptosis by a mechanism involving downregulation of the expression of survivin and suppression of the activation of PI3K/Akt.

About Tigris Pharmaceuticals, Inc.

Tigris Pharmaceuticals, Inc. is a privately held biopharmaceutical company that develops therapeutic technologies, using a translational research approach, for use in 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.

This news release contains forward-looking statements that involve risks and uncertainties that could cause our actual results and experiences to differ materially from anticipated results and expectations expressed in such forward-looking statement. These forward-looking statements include, without limitation, statements regarding the mechanism of action of GGTI-2418, its potential advantages, its potential for use in treating cancer, as well as the timing, progress and anticipated results of the clinical development and regulatory processes concerning GGTI-2418. These statements are based on our current beliefs and expectations as to such future outcomes, and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Factors that might cause such a material difference include, among others, risks that the results of clinical trials will not support our claims or beliefs concerning the effectiveness of GGTI-2418, our ability to finance our development of GGTI-2418, regulatory risks, and our reliance on third party researchers and other collaborators. We assume no obligation to update these statements, except as required by law.

SOURCE Tigris Pharmaceuticals, Inc.
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