FDA approves Ascenta's IND for AT-406 multi-IAP antagonist

Ascenta Therapeutics announced today that following the approval by the U.S. Food and Drug Administration (FDA) of its Investigational New Drug (IND) Application for AT-406, an orally-active, small molecule, multi-IAP antagonist, the company will initiate a Phase I clinical trial in patients with advanced cancer during the fourth quarter of 2009.

"We are very pleased to be moving our second oral, pro-apoptotic agent into human clinical trials," said Mel Sorensen, MD, CEO of Ascenta Therapeutics. "AT-406 has shown promising anti-tumor activity in a variety of pre-clinical models and we are eager to lay the groundwork for further clinical development with the results of this 'first-in-man' study."

The multi-center, single-agent, open-label, Phase I accelerated dose escalation study will evaluate safety and determine the maximum tolerated dose and optimal dosing schedule of AT-406 in patients with advanced lymphomas and solid tumors. Secondary endpoints will include pharmacodynamic and pharmacokinetic parameters and evidence of anti-tumor activity.