Ascenta To Initiate Phase 1 Clinical Trial For Advanced Cancer Patients

Ascenta Therapeutics has revealed that (following the approval by the FDA for AT-406, an orally-active, small molecule, multi-IAP antagonist) it will initiate a phase 1 clinical trial in patients with advanced cancer during the fourth quarter of 2009.

Reportedly, AT-406 is an orally-active, small molecule drug designed for programmed cell death (apoptosis) in tumor cells by blocking the activity of at least three inhibitors of apoptosis proteins or IAPs, to create conditions in which apoptosis can proceed.

The company said that the multi-center, single-agent, open-label, phase 1 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.

According to the company, secondary endpoints will include pharmacodynamic and pharmacokinetic parameters and evidence of anti-tumor activity.

Mel Sorensen, managing director and CEO of Ascenta, said: “We are very pleased to be moving our second oral, pro-apoptotic agent into human clinical trials. 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.”