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

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.

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"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 activator of caspases) by binding to XIAP and preventing it from inhibiting caspase activation. Upon binding, AT-406 induces rapid degradation of cIAP-1/2 proteins and promotes apoptosis through activation of caspase-8 and the death-receptor complex.

AT-406 has demonstrated strong single-agent antitumor activity in multiple pre-clinical xenograft models of human cancer, including breast cancer, pancreatic cancer, prostate cancer, and lung cancer. AT-406 has also been shown to work synergistically with conventional chemotherapeutic and targeted agents (such as tyrosine kinase inhibitors) in preclinical tumor models.

About Ascenta Therapeutics

Ascenta Therapeutics, Inc. is a privately-held, clinical-stage biopharmaceutical company that discovers and develops new medicines for the treatment of cancer. The company is headquartered in Malvern, Pennsylvania, and has a preclinical research facility in Shanghai, China. Its technology, licensed from both the National Institutes of Health and the laboratory of Dr. Shaomeng Wang at the University of Michigan, is focused on discovering molecules that restore the natural potential for cancer cells to undergo cell death (apoptosis). Ascenta's lead agent, AT-101, is an orally-active small molecule pan Bcl-2 inhibitor (Bcl-2, Bcl-xL, and Mcl-1) currently in Phase 2 clinical trials in castrate resistant prostate cancer. The Company's preclinical pipeline includes the oral multi-IAP antagonist AT-406, and an HDM2-p53 inhibitor program.

For additional information on Ascenta Therapeutics, please visit the company's website at

SOURCE Ascenta Therapeutics
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