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First Patient Dosed in Phase I Clinical Trial of Tigris Pharmaceuticals' GGTI-2418

BONITA SPRINGS, Fla., May 1 /PRNewswire/ -- Tigris Pharmaceuticals, Inc., a privately held drug development company, announced today that dosing has started in a Phase I clinical trial of GGTI-2418. GGTI-2418 is a synthetic peptidomimetic inhibitor of geranylgeranyltransferase I (GGTase I) that induces apoptosis by downregulating several pivotal oncogenic and tumor survival pathways.

The Phase I study is led by Dr. Peter O'Dwyer, Professor of Medicine at the University of Pennsylvania School of Medicine and Program Leader of the Experimental Therapeutics Program at the Abramson Cancer Center of the University of Pennsylvania, and by Dr. Gabriela Chiorean, Assistant Professor of Medicine at the Indiana University School of Medicine and a physician/researcher with the Indiana University Melvin and Bren Simon Cancer Center.

"This is the first geranylgeranyltransferase inhibitor to move to clinical phase studies," stated Edmundo Muniz, M.D., Ph.D., President and Chief Executive Officer of Tigris. "Initiation of this Phase I study of GGTI-2418 in these two top Phase I cancer research centers is a significant step in the development of this first-in-class molecule to treat cancer in many different tumor types."

"We are excited to participate in the first study of this novel agent," commented Dr. Chiorean. "The development of a molecule to inhibit the geranylgeranyltransferase pathway would be a significant advancement in cancer treatment."

The primary objective of the Company's Phase I trial with GGTI-2418 is to determine its safety, tolerability, and recommended Phase II dose. Patients with metastatic solid tumors for which standard treatments have failed, or for whom standard therapies are not available, will be evaluated. The number of patients to be enrolled will depend on the number of patient cohorts investigated until dose-limiting toxicity is reached.

Tigris in-licensed the exclusive worldwide rights to GGTI-2418 from Yale University and the University of South Florida. Said M. Sebti, Ph.D., Director of the Drug Discovery Program at the Moffitt Cancer Center and Andrew Hamilton, Ph.D., Professor of Chemistry at Yale University were the co-inventors of GGTI-2418.

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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