Aegera Therapeutics Inc. is pleased
to announce the dosing of the first patient in a fifth phase 1 and 2
clinical oncology study of AEG35156, a second generation antisense
therapeutic targeting XIAP, a key member of the Inhibitor of Apoptosis
protein family.
The study, made possible, in part, by funding from The Leukemia &
Lymphoma Society, is entitled "A Phase 1-2, Multicenter, Open-Label Study
of the X- Linked Inhibitor of Apoptosis (XIAP) Antisense AEG35156 in
Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia, Small
Lymphocytic Lymphoma and Follicular Lymphoma." It is being conducted at the
Princess Margaret Hospital (PMH) located in Toronto, Ontario, and is led by
Principal Investigator Dr. Christine Chen, with co-Principal Investigators
Dr. Aaron Schimmer and Dr. Joe Brandwein, all from the PMH's Department of
Hematology and Oncology.
The primary objective of this study is to determine the recommended
dose of AEG35156 in patients with relapsed or refractory chronic
lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and follicular
lymphoma (FL), and to determine the safety profile and response rate to
AEG35156 in these patient populations.
"Preliminary evidence of activity in lymphoma was observed in phase 1
studies with AEG35156," stated Dr. Jacques Jolivet, Aegera's VP Clinical.
"This clinical trial will specifically study the role played by XIAP
knockdown in inducing antitumor activity in CLL, SLL and FL."
"Our clinical program around AEG35156 continues to expand and broaden
as we seek to move this therapeutic forward to approval," added Aegera's
President and Chief Executive Officer, Dr. Michael J. Berendt. "By adding
these lymphoma indications to AEG35156's ongoing phase 1 and 2 studies in
leukemia (AML), pancreatic, breast, and non-small cell lung cancer, we
continue to seek to position AEG35156 as an important therapeutic option
that could address important unmet medical needs across a spectrum of
cancer indications. I must also thank, once again, The Leukemia & Lymphoma
Society for their financial support of this study which is the first
funding granted for a clinical trial under their new Therapy Acceleration
Program."
The Leukemia & Lymphoma Society Canada (LLSC) National Board Chairman,
Robert Rollwagen, added, "The initiation of patient enrollment and dosing
in Aegera's clinical trial marks an exciting time for lymphoma patients and
LLSC. We are pleased to help accelerate the testing of a new therapeutic
option for blood cancer patients and that Canadian lymphoma patients are
among the first to participate in this trial."
About AEG35156
Cancer cells acquire multiple mutations that disable their normal
response to apoptotic triggers. AEG35156, a second generation antisense
which targets XIAP, is designed to lower the apoptotic threshold of cancer
cells, enhancing their sensitivity to intrinsic death and chemotherapy,
without harming healthy cells. Aegera's published data with AEG35156, both
in vitro and in vivo, strongly supports this hypothesis, and validates XIAP
as a novel drug target for the development of anti-cancer therapeutics.
About Aegera Therapeutics Inc.
Aegera Therapeutics is a clinical stage biotechnology company focused
on developing drugs that control apoptosis to address major unmet medical
needs. In addition to AEG35156, Aegera has three additional programs in
clinical development for the treatment of cancer and neuropathic pain.
Details of these programs can be found on Aegera's website at
aegera.
About The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society(R), headquartered in White Plains, NY,
with 68 chapters in the United States and Canada, is the world's largest
voluntary health organization dedicated to funding blood cancer research
and providing education and patient services. The LLS mission: Cure
leukemia, lymphoma, Hodgkin's disease and myeloma, and improve the quality
of life of patients and their families. Since its founding in 1949, LLS has
invested more than $600 million in research specifically targeting
leukemia, lymphoma and myeloma. Last year alone, LLS made 5.1 million
contacts with patients, caregivers and healthcare professionals.
Aegera Therapeutics Inc.
aegera