January 30, 2008
Tigris Pharmaceuticals Initiates Phase I Study of AFP-464 in Patients with Solid Tumors
BONITA SPRINGS, Fla., Jan. 30 - Tigris Pharmaceuticals, Inc., a privately held drug development company, has initiated a multi-center, Phase I, ascending dose clinical study of aminoflavone pro-drug (AFP-464) for the treatment of cancer. The first patient was dosed in December 2007 and enrollment is ongoing.
The primary objectives of the study are to determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of AFP-464 in patients with advanced solid tumors. The trial is expected to enroll up to approximately 35 patients across two sites in Europe: Institut Gustave-Roussy, Villejuif, France and Jules Bordet Institute, Brussels, Belgium. Results from the trial are expected to be available in early 2009.
"We are delighted that dosing has begun in this important dose-escalation study of AFP-464 in patients with solid tumors," said Edmundo Muniz, Chief Executive Officer of Tigris. "AFP-464 is a first-in-class molecule with the potential to fill a large unmet medical need in the treatment of cancer. This first trial in Europe along with the two US Phase 1 trials provides us our first opportunity to assess the drug's activity in patients, and to further build on our understanding of the molecule's mechanism of action."
About AFP-464
AFP-464 is a novel anticancer agent currently being investigated in two phase 1 clinical trials sponsored by the National Cancer Institute ("NCI") in patients with solid tumors. Preclinical studies into AFP-464's mechanism of action have shown that AFP-464 is converted to metabolites which bind covalently to DNA, resulting in p53 activation 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 tumor cell lines exhibiting particular sensitivity to the compound. In vivo antitumor activity of AFP-464 has been demonstrated in several xenograft studies in mice bearing renal and breast cancer.
About Tigris Pharmaceuticals, Inc.
Tigris Pharmaceuticals, Inc. is a privately held biopharmaceutical company that develops therapeutic technologies to treat oncology, infectious diseases and other areas of unmet medical need. Tigris is currently conducting a Phase II clinical study for A-007, its topical treatment for pre-cancerous and cancerous anogenital lesions associated with HPV. Tigris is also developing three novel, targeted small molecule oncology compounds. 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.
Contacts:
Anne White
Chief Operating Officer
Tigris Pharmaceuticals, Inc.
(239) 444-5400
info@tigrispharma.com
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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, product pricing and third party reimbursement, and other factors described in our filings with the Securities and Exchange Commission.
