AEG35156 extends extend survival in liver cancer: Aegera

An investigative drug may help increase the survival time of patients suffering from late stage liver cancer.

The drug code-named AEG35156, developed by Aegera Therapeutics Inc, has been found delaying the survival rate of patients when given in combination with other treatment against 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 data from 13 patients treated with drug indicated that AEG35156 is also safe in patients.

“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, ” stated Dr. Jacques  Jolivet, senior vice-President, Clinical of the trial’s sponsor, Aegera Therapeutics.

AEG35156 is a 2nd generation antisense oligonucleotide. This targeted therapy is designed to lower the apoptotic threshold of cancer cells, enhancing their sensitivity to intrinsic death and chemotherapy, without harming healthy cells.

“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.

Aegera is also working on several preclinical programs in the area of autoimmune, inflammatory and central nervous system diseases.

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 iven 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.

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.

Aegera Therapeutics is a clinical stage biotechnology company focused on developing novel targeted therapies. In addition to AEG35156, Aegera is working with its partner Human Genome Sciences 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.