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.
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