Aegera Therapeutics Initiates A Randomized Phase 2 Combination Study Of AEG35156 For 1st Line Treatment Of Non-Small Cell Lung Cancer

Main Category: Lung Cancer
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 09 Jan 2009 - 0:00 PDT

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Aegera Therapeutics Inc. announced the dosing of the first patient in a randomized Phase 2 study of AEG35156, their targeted antisense therapeutic in mid-stage development for multiple oncology indications.

The study, entitled "A Phase 2, Multicenter, Open-Label, Randomized Study of the X-Linked Inhibitor of Apoptosis (XIAP) Antisense AEG35156 Given In Combination With Carboplatin/Paclitaxel or the Combination of Carboplatin/Paclitaxel Alone In Patients With Advanced Non Small Cell Lung Cancer" is being conducted in the United States in collaboration with U.S. Oncology and additional sites will be opened in Canada. The Principal Investigator of this study is Dr. Robert M. Jotte, of the Rocky Mountain Cancer Center in Denver, Colorado.

The primary objective of this study is to compare the efficacy of the standard of care for this patient population to the standard of care in combination with AEG35156. Recruitment for this trial is expected to be completed prior to the end of 2009.

"Preliminary evidence of activity was observed in the Phase 1 portion of this study and encouraged us to amend the clinical protocol to provide for a control arm for the Phase 2 portion of the study" stated Dr. Jacques Jolivet, Senior Vice-President of Clinical Development of Aegera.

"Our clinical program around AEG35156 continues to accelerate and expand as we seek to move this therapeutic forward to more advanced stages of clinical development," added Aegera's President and Chief Executive Officer, Dr. Michael J. Berendt. "The initiation of this randomized Phase 2 study in lung cancer follows very shortly after our publication of positive clinical data from our Phase 1/2 study in AML at the recent ASH conference in San Francisco and represents the first of multiple new clinical trials for this innovative therapy that we hope to announce over the course of 2009."

About AEG35156

Cancer cells acquire multiple mutations that disable their normal response to apoptotic triggers. AEG35156, a second generation antisense which targets XIAP, is designed to lower the apoptotic threshold of cancer cells, enhancing their sensitivity to intrinsic death and chemotherapy, without harming healthy cells. Aegera's published data with AEG35156, both in vitro and in vivo, strongly supports this hypothesis, and validates XIAP as a novel drug target for the development of anti-cancer therapeutics.

About Aegera Therapeutics Inc.

Aegera Therapeutics is a clinical stage biotechnology company focused on developing novel targeted therapies that address major unmet medical needs. In addition to AEG35156, Aegera has two additional programs in clinical development for the treatment of cancer and neuropathic pain. Details of these programs can be found on Aegera's website at http://www.aegera.com.

AEGERA THERAPEUTICS INC.
http://www.aegera.com

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