BONITA SPRINGS, Fla., May 15 Tigris Pharmaceuticals, Inc.announced today the execution of a Cooperative Research and DevelopmentAgreement (CRADA) with the National Cancer Institute (NCI) to collaborate onclinical and preclinical development of AFP-464, an aminoflavone currently inPhase I development. AFP-464 is converted to metabolites which bindcovalently to DNA, resulting in p53 activation and apoptosis.
This is part of a four-year CRADA encompassing multiple Phase I and PhaseII clinical studies with correlating translational research of AFP-464 in avariety of tumor types. The goal of this research collaboration is to worktogether for the successful development of AFP-464 as a safe and effectivenovel 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 theUniversity of Maryland. These studies are evaluating AFP-464 in patients withadvanced solid tumors. Tigris has also initiated a Phase I program at leadingcancer research centers in Belgium and France; this work is not included inthe CRADA research. The AFP-464 program is anticipated to move to Phase IIdevelopment in 2009.
"It will be a privilege to work with the NCI on such a promisingtherapeutic for patients with cancer," stated Edmundo Muniz, M.D., Ph.D.,Chief Executive Officer of Tigris. "This CRADA further solidifies thesuccessful partnership to date between Tigris and the NCI."
Preclinical studies into AFP-464's mechanism of action have shown thatAFP-464 induces CYP1A1/1A2 and CYP1B1 protein expression and is converted tometabolites that are covalently bound to DNA, resulting in phosphorylation ofp53 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's60 tumor cell line screen, with breast, ovarian, lung and renal linesexhibiting particular sensitivity. In vivo antitumor activity of AFP-464 hasbeen demonstrated in several xenograft studies in mice.
About The National Cancer Institute
The National Cancer Institute (NCI) is a part of the National Institutesof Health (NIH) and was established in 1937 under the National Cancer Act; thefederal government's principal agency for cancer research and training. TheNational Cancer Act of 1971 expanded the responsibilities of the NCI andcreated the National Cancer Program. The National Cancer Program conducts andsupports research, training, health information dissemination and otherprograms with respect to the cause, diagnosis, prevention and treatment ofcancer, rehabilitation from cancer, and the continuing care of cancer patientsand the families of cancer patients.
About Tigris Pharmaceuticals, Inc.
Tigris Pharmaceuticals, Inc. is a privately held biopharmaceutical companythat develops therapeutic technologies to treat oncology and other areas ofunmet medical need. Tigris' mission is to efficiently move its existing andfuture technologies through the various stages of clinical development inorder to meet patients' needs for safe and effective treatments of humanillnesses.
This news release contains forward-looking statements. Such statements arevalid only as of today, and we disclaim any obligation to update thisinformation. These statements are subject to known and unknown risks anduncertainties that may cause actual future experience and results to differmaterially from the statements made. These statements are based on our currentbeliefs and expectations as to such future outcomes. Drug discovery anddevelopment involve a high degree of risk. Factors that might cause such amaterial difference include, among others, uncertainties related to theability to attract and retain partners for our technologies, theident