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.
