Aeterna Zentaris Announces Completion of Interim Analysis by Data Safety Monitoring Board for the Phase 3 Study of Perifosine for the Treatment of Refractory Advanced Colorectal Cancer
Independent Committee Recommends Phase 3 X-PECT Study to Proceed as
QUÃƒ“°BEC CITY, Aug. 31, 2011 /PRNewswire/ – Aeterna Zentaris Inc. (NASDAQ:
AEZS) (TSX: AEZ) (the ”Company”) today announced that the independent
Data Safety Monitoring Board (DSMB) for the pivotal Phase 3 X-PECT
study of perifosine in patients with refractory advanced colorectal
cancer has completed a pre-specified interim analysis for safety and
futility. The DSMB has recommended that the Phase 3 study continue to
completion, as planned.
This Phase 3 study sponsored and conducted by our North American
licensee for perifosine, Keryx Biopharmaceuticals, Inc., (Keryx),
(NASDAQ:KERX), has completed enrollment, with over 465 patients from 65
U.S. sites. The study is being conducted pursuant to a Special Protocol
Assessment (SPA) with the Food and Drug Administration (FDA) and with
Fast-Track Designation. Furthermore, the Company has received positive
Scientific Advice from the European Medicines Agency (EMA) for this
ongoing Phase 3 trial, which is therefore expected to be sufficient for
registration in Europe. Perifosine rights have also been licensed to
Yakult Honsha for Japan and to Handok for Korea.
The Phase 3 trial, entitled the “X-PECT” (Xeloda(Ã‚®) + 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 465
randomized patients with refractory advanced colorectal cancer.
Patients must have failed available therapy including 5-fluorouracil
(5-FU), oxaliplatin (Eloxatin(Ã‚®)), irinotecan, bevacizumab (Avastin(Ã‚®)) and, if KRAS wild-type, failed therapy with prior cetuximab (Erbitux(Ã‚®)) and/or panitumumab (Vectibix(Ã‚®)). 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 unblinding of the study.
Juergen Engel, Ph.D., President and CEO of Aeterna Zentaris, commented,
“We are very pleased by the news that the DSMB has recommended that the
study should proceed to completion as planned, and thank the DSMB
members for their work. With this positive news we believe that our
partner Keryx is well positioned to complete the Phase 3 program in
refractory advanced colorectal cancer, which could bring this new
therapy to patients suffering from this disease. We continue to prepare
for the next steps and will work towards commercialization in the rest
of the world.”
About Special Protocol Assessments
The Special Protocol Assessment (SPA) process is a procedure by which
the FDA provides official evaluation and written guidance on the design
and size of proposed protocols that are intended to form the basis for
a new drug application.
Final marketing approval depends on the efficacy and safety results,
including the adverse event profile, and an evaluation of the
benefit/risk of treatment demonstrated in the Phase 3 clinical trial.
The SPA agreement may only be changed through a written agreement
between the sponsor and the FDA, or if the FDA becomes aware of a
substantial scientific issue essential to product efficacy or safety.
For more information on the Special Protocol Assessment procedure,
please visit: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571.pdf.
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.
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 risk that safety and efficacy data
from any of our Phase 3 trials may not coincide with the data analyses
from previously reported Phase 1 and/or Phase 2 clinical trials, 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.