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Aegera Therapeutics is pleased to announce the dosing of the first patient in a fifth phase 1 and 2 clinical oncology study of AEG35156, a second generation antisense therapeutic targeting XIAP, a key member of the Inhibitor of Apoptosis protein family
MONTREAL, CANADA | July 31, 2008 | Aegera Therapeutics Inc. is pleased to announce the dosing of the first patient in a fifth phase 1 and 2 clinical oncology study of AEG35156, a second generation antisense therapeutic targeting XIAP, a key member of the Inhibitor of Apoptosis protein family.
The study, made possible, in part, by funding from The Leukemia & Lymphoma Society, is entitled "A Phase 1-2, Multicenter, Open-Label Study of the X- Linked Inhibitor of Apoptosis (XIAP) Antisense AEG35156 in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma and Follicular Lymphoma." It is being conducted at the Princess Margaret Hospital (PMH) located in Toronto, Ontario, and is led by Principal Investigator Dr. Christine Chen, with co-Principal Investigators Dr. Aaron Schimmer and Dr. Joe Brandwein, all from the PMH's Department of Hematology and Oncology.
The primary objective of this study is to determine the recommended dose of AEG35156 in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and follicular lymphoma (FL), and to determine the safety profile and response rate to AEG35156 in these patient populations.
"Preliminary evidence of activity in lymphoma was observed in phase 1 studies with AEG35156," stated Dr. Jacques Jolivet, Aegera's VP Clinical. "This clinical trial will specifically study the role played by XIAP knockdown in inducing antitumor activity in CLL, SLL and FL."
"Our clinical program around AEG35156 continues to expand and broaden as we seek to move this therapeutic forward to approval," added Aegera's President and Chief Executive Officer, Dr. Michael J. Berendt. "By adding these lymphoma indications to AEG35156's ongoing phase 1 and 2 studies in leukemia (AML), pancreatic, breast, and non-small cell lung cancer, we continue to seek to position AEG35156 as an important therapeutic option that could address important unmet medical needs across a spectrum of cancer indications. I must also thank, once again, The Leukemia & Lymphoma Society for their financial support of this study which is the first funding granted for a clinical trial under their new Therapy Acceleration Program."
The Leukemia & Lymphoma Society Canada (LLSC) National Board Chairman, Robert Rollwagen, added, "The initiation of patient enrollment and dosing in Aegera's clinical trial marks an exciting time for lymphoma patients and LLSC. We are pleased to help accelerate the testing of a new therapeutic option for blood cancer patients and that Canadian lymphoma patients are among the first to participate in this trial."
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 drugs that control apoptosis 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.
About The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society(R), headquartered in White Plains, NY, with 68 chapters in the United States and Canada, is the world's largest voluntary health organization dedicated to funding blood cancer research and providing education and patient services. The LLS mission: Cure leukemia, lymphoma, Hodgkin's disease and myeloma, and improve the quality of life of patients and their families. Since its founding in 1949, LLS has invested more than $600 million in research specifically targeting leukemia, lymphoma and myeloma. Last year alone, LLS made 5.1 million contacts with patients, caregivers and healthcare professionals.
SOURCE: Aegera Therapeutics Inc.
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