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Ascenta Therapeutics Receives Clearance to Initiate Clinical Trials With AT-406
Date:9/10/2009

MALVERN, Pa., Sept. 10 /PRNewswire/ -- 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.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090227/PH75873LOGO )

"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.

About AT-406

AT-406 is an orally-active, small molecule drug designed to promote programmed cell death (apoptosis) in tumor cells by blocking the activity of at least three "inhibitors of apoptosis proteins" or IAPs (including XIAP, c-IAP1, and c-IAP2) to create conditions in which apoptosis can proceed. As such, AT-406 is considered a multi-IAP antagonist. IAPs are key components of the complex cascade of protein signaling that activates enzymes called caspases to initiate breakdown of the cancer cell. AT-406 is thought to mimic the activity of Smac (second mitochondria-derived ac
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SOURCE Ascenta Therapeutics
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