MONTREAL, Jan. 8 /CNW Telbec/ - Aegera Therapeutics Inc. announced today
the dosing of the first patient in a randomized Phase 2 study of AEG35156,
their targeted antisense therapeutic in mid-stage development for multiple
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."
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 www.aegera.com.
For further information:
For further information: Donald Olds, MSc, MBA, Chief Operating Officer
& Chief Financial Officer, Aegera Therapeutics Inc., (514) 288-5532 *295,