Aegera Therapeutics' Phase 1/2 Clinical Trial Results Selected for Oral Presentation at 2008 ASH Annual Meeting

MONTREAL, November 25, 2008 /PRNewswire/ - Aegera Therapeutics Inc. today announced that data from its phase 1/2 clinical trial of the XIAP antisense oligonucleotide, AEG35156, will be highlighted in an oral presentation at the 50th Annual Meeting of the American Society of Hematology (ASH) in San Francisco, California, on December 9, 2008.

The presentation is entitled "Phase I/II Trial of the XIAP Antisense Oligonucleotide (AEG35156) in Combination with Idarubicin and Cytarabine in Patients with Relapsed/Refractory AML". The trial was an open label, multi-center study evaluating the safety and efficacy of AEG35156 in combination with chemotherapy in AML patients in first relapse after a short initial CR or with primary refractory disease. A total of 51 patients were enrolled in the study. The results demonstrate that AEG35156 is well tolerated at 350 mg/m2 in combination with idarubicin and cytarabine. The results also support the finding that AEG35156 combination therapy may induce high response rates in AML patients not responding to frontline induction therapy. Updated results on additional patients will be presented at the ASH Annual Meeting.

The study's principal investigator, Dr. Aaron D. Schimmer, M.D., Ph.D. of the Princess Margaret Hospital in Toronto will present the results of this study at the ASH session entitled "Acute Myeloid Leukemia - Therapy, Excluding Transplantation".

In addition, PD data from the same study will be presented by Dr. Carter Bing of the MD Anderson Cancer Center in a poster on December 7 under the title "Pharmacodynamic Study of Phase 1/2 Trial of the XIAP Antisense Oligonucleotide (AEG35156) in Combination with Chemotherapy in Patients with Relapsed/Refractory AML".

Details of each of these presentations are listed below.

 

2008 ASH Annual Meeting ASH - Oral Presentation

 

Title: Phase I/II Trial of the XIAP Antisense Oligonucleotide (AEG35156)

in Combination with Idarubicin and Cytarabine in Patients with

Relapsed/Refractory AML

 

Session Name: Acute Myeloid Leukemia - Therapy, Excluding Transplantation

Session Date: Tuesday, December 9th, 2008 Presentation Time: 7:45 AM

Session Location: Moscone Center, Room 3020-3022-3024 - West

 

2008 ASH Annual Meeting - Poster Presentation

 

Title: Pharmacodynamic Study of Phase 1/2 Trial of the XIAP Antisense

Oligonucleotide (AEG35156) in Combination with Chemotherapy in Patients

with Relapsed/Refractory AML

 

Abstract: #1943, Poster Board # II-37

Session Date: Sunday, December 7th, 2008

Session Time: 6:00 PM - 8:00 PM

Session Location: Moscone Center, Hall A

 

About AEG35156

 

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. Aegera's published data with AEG35156, both in vitro and in vivo, strongly supports this hypothesis, and validates XIAP as a novel oncology drug target. The activity of AEG35156 is currently being explored, in combination, or as a monotherapy, in the following indications: acute myeloid leukemia, non-small cell lung cancer, hepatocarcinoma, and chronic lymphocytic leukemia and indolent B-cell lymphomas. The latter study is being conducted with the financial and scientific support of the Leukemia and Lymphoma Society through their innovative Therapy Acceleration Program.

 

About Aegera Therapeutics Inc.

 

Aegera Therapeutics is a clinical stage biotechnology company focused on developing targeted therapeutics to address major unmet medical needs. In addition to AEG35156, Aegera has three 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.

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

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Posted: November 2008

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