Aegera Therapeutics Initiates a Randomized Phase 2 Study with AEG35156 for the Treatment of Hepatocellular Carcinoma
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|Tuesday, 26 January 2010 18:50 (UTC + 1)|
b3c newswire / - Aegera Therapeutics Inc. announced today the successful completion of a dose-ranging Phase 1 study and the initiation of a randomized Phase 2 study of AEG35156 in combination with sorafenib for the treatment of patients with advanced hepatocellular carcinoma (primary liver cancer).
This new study, entitled "A Phase 2, Open-Label Study of The X-Linked Inhibitor of Apoptosis (XIAP) Antisense AEG35156 in Combination with Sorafenib in Patients With Advanced Hepatocellular Carcinoma", is being conducted in Hong Kong. The study is projected to recruit approximately 50 patients with two thirds receiving the combination of AEG35156 and sorafenib and one third receiving sorafenib alone.
"We are pleased with the conduct and results of the Phase 1 portion of this trial. AEG35156 appears to be well tolerated when given in combination with sorafenib. We are now focused on completing recruitment to the randomized Phase 2 portion of the clinical trial to determine if the AEG35156/sorafenib combination can bring an additional therapeutic benefit to this under-served oncology population,” stated Dr. Jacques Jolivet, Senior Vice-President of Clinical Development of Aegera.
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 randomized Phase 2 study for the treatment of acute myeloid leukemia and 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.
About Aegera Therapeutics Inc. - www.aegera.com
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 with its partner Human Genome Sciences (NASDAQ:HGSI) to progress HGS1029 through early stage clinical development. Additional information on these programs can be found on Aegera’s website at www.aegera.com.
Aegera Therapeutics Inc.
Donald Olds, MSc, MBA
Chief Operating Officer & CFO
(514) 288-5532 *295