FDA accepts IND application for Tigris Pharmaceutical's GGTI-2418

Tigris Pharmaceuticals, Inc., has 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.