All amounts are in U.S. dollars (unless otherwise
noted)
QUÉBEC CITY, July 31,
2013 /CNW Telbec/ - Aeterna Zentaris Inc. (NASDAQ: AEZS)
(TSX: AEZ) (the "Company") today announced that the first
patient has been recruited and dosed for the Phase 3 ZoptEC
(Zoptarelin doxorubicin in Endometrial Cancer)
trial in women with endometrial cancer resistant to
platinum/taxane-based chemotherapy.
"We have reached another important milestone in the final
clinical development stage for zoptarelin doxorubicin (AEZS-108) in
treating endometrial cancer. Efforts are now focused on pursuing
patient recruitment as swiftly as possible", stated David Dodd, President and CEO of Aeterna
Zentaris. "This compound's innovative targeted approach potentially
offers a much needed novel treatment option for women with
endometrial cancer and it provides the Company with a significant
market opportunity."
The Study
This is an open-label, randomized, multicenter Phase 3
trial to be conducted in over 120 sites in North America, Europe, Israel and other countries under a Special
Protocol Assessment, comparing zoptarelin doxorubicin (AEZS-108)
with doxorubicin as second line therapy for locally-advanced,
recurrent or metastatic endometrial cancer. Lead investigators are
David Scott Miller, MD, from the
University of Texas Southwestern Medical
Center, in Dallas, Texas, and
Hani Gabra, MD, from the Imperial College London Hammersmith Campus
in London, England. The trial will
involve approximately 500 patients and the primary efficacy
endpoint is improvement in median Overall Survival.
Selected as the contract clinical development organization,
Ergomed will also assume 30% (up to $10 million) of the clinical and regulatory
costs for this trial.
Details for this trial are available at www.clinicaltrials.gov
(NCT01767155).
About Zoptarelin Doxorubicin (AEZS-108)
Zoptarelin doxorubicin (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.
Zoptarelin doxorubicin (AEZS-108) is the first intravenous drug in
advanced clinical development that directs the chemotherapy agent
specifically to LHRH-receptor expressing tumors, resulting in a
more targeted treatment with less damage to healthy tissue. The
Company is currently conducting a Phase 3 trial in endometrial
cancer under a Special Protocol Assessment, while zoptarelin
doxorubicin (AEZS-108) is also in Phase 2 trials for
triple-negative breast cancer, prostate cancer and bladder cancer.
Aeterna Zentaris owns the worldwide rights to zoptarelin
doxorubicin (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, an estimated 49,560 new cases of endometrial cancer in the
U.S., and 35,600 in Europe, are
expected during 2013, with about 20% of recurring disease.
About Aeterna Zentaris
Aeterna Zentaris is a specialty biopharmaceutical company
engaged in developing novel treatments in oncology and
endocrinology. The Company's pipeline encompasses compounds from
drug discovery to regulatory approval. For more information, 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.