QUEBEC CITY, July 27, 2011 /PRNewswire/ - Aeterna Zentaris
Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced
the completion of patient recruitment for the ongoing Phase 3 trial
with perifosine in refractory advanced colorectal cancer. The
trial, involving over 430 patients, is being conducted pursuant to
a Special Protocol Assessment (SPA) with the Food and Drug
Administration (FDA) and with Fast Track Designation. It is
sponsored by Keryx Biopharmaceuticals, Inc., (Keryx), (NASDAQ:
KERX), Aeterna Zentaris' licensee for perifosine in North America. Perifosine is a novel,
potentially first-in-class, oral anticancer drug candidate that
inhibits Akt activation in the phosphoinositide 3-kinase (PI3K)
pathway.
Juergen Engel, Ph.D., Aeterna
Zentaris President and Chief Executive Officer, commented, "We wish
to congratulate our partner Keryx and thank all those involved in
reaching this key patient recruitment milestone within a 16-month
timeframe. We now look forward to the completion of this pivotal
Phase 3 trial in order to potentially provide an additional
treatment to refractory advanced colorectal cancer patients."
Phase 3 Trial Design
The Phase 3 trial, entitled the "X-PECT"
(Xeloda® + Perifosine Evaluation in
Colorectal cancer Treatment) trial, is a randomized
(1:1), double-blind trial comparing the efficacy and safety of
perifosine + capecitabine vs. placebo + capecitabine in over 430
patients with refractory advanced colorectal cancer. Patients must
have failed available therapy including 5-fluorouracil (5-FU),
oxaliplatin (Eloxatin®), irinotecan, bevacizumab
(Avastin®) and, if KRAS wild-type, failed prior therapy
with cetuximab (Erbitux®) and/or panitumumab
(Vectibix®). The primary endpoint is overall survival,
with secondary endpoints including overall response rate (complete
+ partial responses), progression-free survival and safety.
Approximately 360 events of death will trigger the un-blinding of
the study.
Dr. Johanna Bendell, Director of
GI Oncology Research for the Sarah Cannon Research Institute,
Nashville, Tennessee, is Study
Chair for the Phase 3 investigational team. Dr. Cathy Eng, Associate Medical Director for the
Colorectal Center at MD Anderson Cancer Center in Houston, Texas, is the Lab Correlative Study
Chair leading the biomarker analyses. Sixty-five U.S. sites are
participating in the study.
About Colorectal Cancer
According to the American Cancer Society, colorectal cancer is
the third most common form of cancer diagnosed in the United States. It is estimated that over
141,000 people will be diagnosed with some form of colorectal
cancer with over 49,000 patients dying from colorectal cancer in
2011. Surgery is often the main treatment for early stage
colorectal cancer. When colorectal cancer metastasizes (spreads to
other parts of the body such as the liver) chemotherapy is commonly
used. Treatment of patients with recurrent or advanced colorectal
cancer depends on the location of the disease. Chemotherapy
regimens (i.e. FOLFOX or FOLFIRI either with or without
bevacizumab) have been shown to increase survival rates in patients
with advanced colorectal cancer. Currently, there are seven
approved drugs for patients with advanced colorectal cancer:
5-fluorouracil (5-FU), capecitabine (Xeloda®),
irinotecan, oxaliplatin (Eloxatin®), bevacizumab
(Avastin®), cetuximab (Erbitux®), and
panitumumab (Vectibix®). Depending on the stage of the
cancer, two or more of these types of treatment may be combined at
the same time or used after one another. For example, FOLFOX
combines 5-FU, leucovorin and oxaliplatin and FOLFIRI combines
5-FU, leucovorin and irinotecan. Bevacizumab, a VEGF monoclonal
antibody, is commonly administered with chemotherapy. Typically,
patients who fail 5-FU, oxaliplatin, irinotecan, and
bevacizumab-containing therapies, and who have wild-type KRAS
status receive EGFR monoclonal antibody therapy with either
cetuximab or panitumumab. Once patients progress on these agents,
there are no further standard treatment options.
About Perifosine
Perifosine is a novel, oral anticancer treatment that inhibits
Akt activation in the phosphoinositide 3-kinase (PI3K) pathway. The
product works by interfering with membranes of cancer cells thereby
inhibiting Akt signaling which then affects cell death, growth,
differentiation and survival. Perifosine, in combination with
chemotherapeutic agents, is currently being studied for the
treatment of multiple myeloma, colorectal cancer and other cancers,
and is the most advanced anticancer agent of its class. Perifosine,
as monotherapy, is being explored in other indications. The FDA has
granted perifosine orphan-drug designation in multiple myeloma and
neuroblastoma, and Fast Track designations in both multiple myeloma
and refractory advanced colorectal cancer. Additionally, an
agreement was reached with the FDA to conduct the Phase 3
trials in both of these indications under a Special Protocol
Assessment. Perifosine has also been granted orphan medicinal
product designation from the European Medicines Agency (EMA) in
multiple myeloma. Furthermore, perifosine has received positive
Scientific Advice from the EMA for both the multiple myeloma and
advanced colorectal cancer programs, with ongoing Phase 3 trials
for these indications expected to be sufficient for registration in
Europe. Perifosine rights have
been licensed to Keryx for North
America, to Yakult Honsha for Japan and to Handok for Korea.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a late-stage oncology drug development
company currently investigating potential treatments for various
cancers including colorectal, multiple myeloma, endometrial,
ovarian, prostate and bladder cancer. The Company's innovative
approach of "personalized medicine" means tailoring treatments to a
patient's specific condition and to unmet medical needs. Aeterna
Zentaris' deep pipeline is drawn from its proprietary discovery
unit providing the Company with constant and long-term access to
state-of-the-art therapeutic options. For more information please
visit www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made
pursuant to the safe harbour provisions of the U.S. Securities
Litigation Reform Act of 1995. Forward-looking statements involve
known and unknown risks and uncertainties that could cause the
Company's actual results to differ materially from those in the
forward-looking statements. Such risks and uncertainties include,
among others, the availability of funds and resources to pursue
R&D projects, the successful and timely completion of clinical
studies, the ability of the Company to take advantage of business
opportunities in the pharmaceutical industry, uncertainties related
to the regulatory process and general changes in economic
conditions. Investors should consult the Company's quarterly and
annual filings with the Canadian and U.S. securities commissions
for additional information on risks and uncertainties relating to
forward-looking statements. Investors are cautioned not to rely on
these forward-looking statements. The Company does not undertake to
update these forward-looking statements. We disclaim any obligation
to update any such factors or to publicly announce the result of
any revisions to any of the forward-looking statements contained
herein to reflect future results, events or developments, unless
required to do so by a governmental authority or by applicable
law.
SOURCE AETERNA ZENTARIS INC.