Aeterna Zentaris Granted Special Protocol Assessment by the FDA for
Phase 3 Registration Trial in Endometrial Cancer with AEZS-108
QUÉBEC CITY, Dec. 28, 2012 /CNW
Telbec/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the
"Company") today announced that it has reached an agreement with
the U.S. Food and Drug Administration ("FDA") on a Special Protocol
Assessment ("SPA") for an upcoming Phase 3 registration trial in
endometrial cancer with its doxorubicin peptide conjugate,
AEZS-108. The SPA agreement states that the proposed trial protocol
design, clinical endpoints and planned analyses are acceptable to
the FDA to support a regulatory submission.
"We are pleased with the agreement with the FDA which provides
us with a clearly defined development and regulatory pathway for
AEZS-108 in endometrial cancer", stated Juergen Engel, PhD, President and CEO at Aeterna
Zentaris. "AEZS-108's innovative targeted approach could offer a
new treatment option for women with endometrial cancer and provide
the Company with a significant market opportunity."
Study Design
This will be an open-label, randomized, multicenter Phase 3
trial conducted in North America
and Europe, comparing AEZS-108
with doxorubicin as second line therapy for locally-advanced,
recurrent or metastatic endometrial cancer. The trial will involve
approximately 500 patients and the primary efficacy endpoint is
improvement in median Overall Survival.
About Special Protocol Assessments ("SPA")
The 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
Biologics License Application ("BLA") or New Drug Application
("NDA"). Final marketing approval depends on the results of
efficacy, the adverse event profile and an evaluation of the
benefit/risk of treatment demonstrated in the Phase 3 trial.
About AEZS-108
AEZS-108 represents a new targeting concept in oncology using a
hybrid molecule composed of a synthetic peptide carrier and a
well-known chemotherapy agent, doxorubicin. AEZS-108 is the first
intravenous drug in advanced clinical development that directs the
chemotherapy agent specifically to Luteinizing Hormone Releasing
Hormone ("LHRH")-receptor expressing tumors, resulting in more
targeted treatment with less damage to healthy tissue. The product
has successfully completed Phase 2 studies for the treatment of
ovarian and endometrial cancer and the Company is currently
planning a Phase 3 trial in endometrial cancer under a Special
Protocol Assessment. AEZS-108 is also in Phase 2 trials in
prostate, breast and bladder cancer. AEZS-108 has been granted
orphan drug designation by the FDA and orphan medicinal product
designation from the European Medicines Agency for the treatment of
ovarian cancer. Aeterna Zentaris owns the worldwide rights to
AEZS-108.
About Endometrial Cancer
Endometrial cancer is the most common gynecologic malignancy and
develops when abnormal cells amass to form a tumor in the lining of
the uterus. It largely affects women over the age of 50 with a
higher prevalence in Caucasians and a higher mortality rate among
African Americans. Approximately one in 30 women is diagnosed with
endometrial cancer every year. According to the American Cancer
Society, 47,130 new cases of endometrial are expected to be
diagnosed in the United States in
2012, and Data Monitor expects 35,600 new cases in
EU-G5 in 2013, with about 20% recurrent disease.
About Aeterna Zentaris
Aeterna Zentaris is an oncology and endocrinology drug
development company currently investigating treatments for various
unmet medical needs. The Company's pipeline encompasses compounds
at all stages of development, from drug discovery through to
marketed products. 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 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.