BONITA SPRINGS, Fla., Jan. 30 /PRNewswire/ -- 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."
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 brea
|SOURCE Tigris Pharmaceuticals, Inc.|
Copyright©2008 PR Newswire.
All rights reserved