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Aegera Therapeutics Initiates a Randomized Phase 2B Study with AEG35156 for the Treatment of Acute Myeloid Leukemia (AML)


11/19/2009 8:52:38 AM

MONTREAL, Nov. 19 /PRNewswire/ - Aegera Therapeutics Inc. announced today the dosing of the first patient in a randomized Phase 2B study of AEG35156, a targeted antisense therapeutic in mid-stage development for multiple oncology indications.

The study, entitled "An Open-Label Randomized Phase 2 Study of the X-Linked Inhibitor of Apoptosis (XIAP) Antisense AEG35156 Given in Combination with High-dose Cytarabine and Idarubicin in AML Following Failure of a Single Standard Dose Cytarabine Based Frontline Induction Regimen", is being conducted in the United States and Canada and will also be conducted in Germany, subject to final regulatory approval. This clinical trial follows shortly after the completion of Aegera's first Phase 2 clinical trial in this indication, the results of which were recently reported in the Journal for Clinical Oncology (J Clin Oncol. 2009 Oct 1;27(28):4741-6).

"Strong demonstration of activity in our non-randomized Phase 2A study conducted in this indication have encouraged us to rapidly initiate a randomized Phase 2B study in AML to confirm our hypothesis that AEG35156 may indeed be significantly improving the response rates in this under-served population of AML patients. If the responses observed in this randomized study are similar to the clinical results that we have already published, we will accelerate our efforts to complete all additional trials required to apply for regulatory approval in North America, Europe and Asia" stated Dr. Jacques Jolivet, Senior Vice-President of Clinical Development of Aegera.

About AEG35156

AEG35156 is a 2nd generation antisense oligonucleotide which targets XIAP; it is designed to lower the apoptotic threshold of cancer cells, enhancing their sensitivity to intrinsic death and chemotherapy, without harming healthy cells. Other currently enrolling studies include a Phase 1/2 monotherapy study in CLL/indolent B-cell lymphomas, which is fully funded by The Leukemia and Lymphoma Society of North America, and a Phase 1/2 randomized combination study with sorafenib in first-line hepatocellular carcinoma being conducted in Hong Kong.

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 is completing a Phase 2A study of AEG33773 in diabetic neuropathic pain and is working to progress HGS1029 through early stage clinical development with its partner Human Genome Sciences . Additional information on these programs can be found on Aegera's website at www.aegera.com.

CONTACT: Donald Olds, MSc, MBA, Chief Operating Officer & CFO, Aegera
Therapeutics Inc., (514) 288-5532 *295, donald.olds@aegera.com



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