Ascenta Therapeutics Receives FDA Clearance to Initiate Clinical Trials With AT-406

Thu, 09/10/2009 - 5:49am
Ascenta Therapeutics announcedtoday that following the approval by the FDA of its Investigational New Drug (IND) Application for AT-406, anorally-active, small molecule, multi-IAP antagonist, the company will initiatea Phase I clinical trial in patients with advanced cancer during the fourthquarter of 2009. "We are very pleased to be moving our second oral, pro-apoptotic agentinto human clinical trials," said Mel Sorensen, MD, CEO of AscentaTherapeutics. "AT-406 has shown promising anti-tumor activity in a variety ofpre-clinical models and we are eager to lay the groundwork for furtherclinical development with the results of this 'first-in-man' study." The multi-center, single-agent, open-label, Phase I accelerated doseescalation study will evaluate safety and determine the maximum tolerated doseand optimal dosing schedule of AT-406 in patients with advanced lymphomas andsolid tumors. Secondary endpoints will include pharmacodynamic andpharmacokinetic parameters and evidence of anti-tumor activity.

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