Aegera Therapeutics Reports Survival Data from the Phase 1 Portion of its Phase 1-2 Study of AEG35156 in Combination with Sorafenib in Patients with Advanced Hepatocellular Carcinoma
MONTREAL and HONG KONG, China, July 19 /PRNewswire/ -- 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
About AEG35156
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.
CONTACT: Donald Olds, MSc, MBA, Chief Operating Officer &
CFO, Aegera
Therapeutics Inc., (514) 288-5532 *295, Email: donald.olds@aegera.com;
Benny
C.Y. Zee, Chinese University of Hong Kong, Assistant Dean
(Research), Faculty
of Medicine, Centre for Clinical Trials, 852 2252 8865,
Email:
bzee@cuhk.edu.hk
Posted: July 2010
