MONTREAL and HONG KONG, China, July 19 /CNW Telbec/ - Aegera Therapeutics Inc. released today encouraging survival data from the Phase 1 portion of its Phase 1-2 Study of the novel targeted therapeutic, AEG35156, given in combination with sorafenib in patients with advanced hepatocellular carcinoma (primary liver cancer).
This study, entitled "A Phase 1-2, 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 exclusively in Hong Kong.
The interim data, derived from the analysis of the 13 patients treated in the Phase 1 portion of this trial indicates that AEG35156 not only appears to be well tolerated when given in combination with sorafenib but may also prolong progression-free and overall survival when compared to historical data where patients were treated with sorafenib alone. Indeed, median progression-free survival of the Phase 1 patients was about 4 months and overall survival about 10 months. This data compares favorably with the median progression-free survival of 2.8 months and overall survival of 6.5 months noted in the sorafenib Phase 3 registration trial performed in the Asia Pacific region in a similar patient population.
"I am greatly encouraged by this interim data read and look forward to completing this study as quickly as possible to ascertain whether the improved survival data can be confirmed in the Phase 2 portion of the trial." declared Dr. Jacques Jolivet, Senior Vice-President, Clinical of the trial's sponsor, Aegera Therapeutics.
"We are excited about the results of the Phase I portion and now focused on completing recruitment to the randomized Phase 2 portion of the clinical trial to confirm the therapeutic benefit of the AEG35156/sorafenib combination" stated Professor Benny Chung-Ying Zee, PhD, Director of the Centre for Clinical Trials, School of Public Health and Primary Care, Faculty of Medicine, The Chinese University of Hong Kong.
For more information of the study please refers to the following trial registration: http://clinicaltrials.gov/ct2/show/NCT00882869
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. Patients are also being currently enrolled in 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.
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 working with its partner Human Genome Sciences (NASDAQ: HGSI) to progress HGS1029 through early stage clinical development for oncology and is also actively working on several preclinical programs in the area of autoimmune, inflammatory and central nervous system diseases. Additional information on these programs can be found on Aegera's website at www.aegera.com.
About Centre for Clinical Trials of the Chinese University of Hong Kong
The Centre for Clinical Trials (CCT) was established under the School of Public Health of the Chinese University of Hong Kong in order to promote good clinical practice in clinical research and clinical trials in Asia. It provides quality education, clinical research services and infrastructure to support local, regional and international clinical trials. For more information about CCT, please visit www.cct.cuhk.edu.hk
SOURCE AEGERA THERAPEUTICS INC.
For further information: For further information: Donald Olds, MSc, MBA, Chief Operating Officer & CFO, Aegera Therapeutics Inc., (514) 288-5532 *295, Email: firstname.lastname@example.org; Benny C.Y. Zee, Chinese University of Hong Kong, Assistant Dean (Research), Faculty of Medicine, Centre for Clinical Trials, 852 2252 8865, Email: email@example.com