Patient recruitment in line to secure expected interim
analysis in H1 2015
All amounts are in U.S. dollars (unless otherwise
noted)
QUÉBEC CITY, Nov. 20, 2014 /CNW
Telbec/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the
"Company") today announced the opening of a new clinical site at
the Hollings Cancer Center of the Medical
University of South Carolina in Charleston, South Carolina, for the Company's
ongoing multinational, pivotal ZoptEC (Zoptarelin
doxorubicin in Endometrial Cancer) Phase 3 trial in
women with advanced, recurrent or metastatic endometrial cancer.
The Hollings Cancer center is the only National Cancer Institute
designated cancer center in South
Carolina and the state's largest academic‑based cancer
program. Furthermore, the Company announced that patient
recruitment for this trial now stands at over 320 patients out of a
projected total of 500 patients.
David Dodd, Chairman, CEO at
Aeterna Zentaris stated, "Patient recruitment for our ZoptEC Phase
3 trial in endometrial cancer, our lead oncology program, is in
line with our projected timelines to secure a first interim
analysis in the first half of 2015 by an independent Data Safety
Monitoring Board. Today, there is no FDA approved therapy for
treating women suffering from advanced, recurrent or metastatic
endometrial cancer. Our hope is that our novel product will be
successful in this trial and subsequently, become a core tool in
improving the lives of women with this type of cancer. Also, we are
very pleased to be working with the Hollings Cancer Center at the
Medical University of South Carolina
for this trial, and look forward to other future collaborations
with this most prestigious institution as part of our plan to
establish activities in the Charleston area, one of the most thriving and
exciting business communities in the
United States."
Jennifer Young Pierce, MD,
Assistant Professor of Obstetrics & Gynecology and Principal
Investigator at the Hollings Cancer Center, Medical University of South Carolina added,
"Metastatic endometrial cancer is a devastating disease, and we see
a disproportionate number of cases at Hollings Cancer Center. Given
the limited therapeutic options for these patients and few clinical
trials available, we are especially excited to collaborate with
Aeterna Zentaris to offer our patients this promising new
therapy."
The ZoptEC Phase 3 trial in endometrial cancer
This is an open-label, randomized, multicenter Phase 3 trial
currently being conducted in North America, Europe and Israel, under a Special Protocol Assessment,
comparing zoptarelin doxorubicin 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 over
120 sites and approximately 500 patients with improvement in median
overall survival as the primary efficacy endpoint. To date, more
than 120 sites are in operation and more than 320 of the expected
500 patients have been entered into the trial.
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
Zoptarelin doxorubicin 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 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 ZoptEC (Zoptarelin
doxorubicin in Endometrial Cancer) Phase 3 trial in
women with advanced, recurrent or metastatic endometrial cancer,
while zoptarelin doxorubicin is also in an investigator-initiated
Phase 2 trial in prostate cancer. Aeterna Zentaris owns the
worldwide rights to this compound.
About Endometrial Cancer
Endometrial cancer is the most common gynecologic malignancy in
developed countries 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. According to the American
Cancer Society, an estimated 49,560 new cases of endometrial cancer
in the U.S., and 35,600 in Europe
were expected during 2013, with about 20% of recurring disease.
About Aeterna Zentaris
Aeterna Zentaris is a specialty biopharmaceutical company
engaged in developing and commercializing novel treatments in
oncology, endocrinology and women's health. For more information,
visit www.aezsinc.com.
About Hollings Cancer Center
Hollings Cancer Center at the Medical
University of South Carolina is a National Cancer
Institute-designated cancer center and the largest academic-based
cancer program in South Carolina.
In addition to the full range of clinical services, the cancer
center has more than $42 million in
cancer research funding and more than 200 clinical trials open to
patients.
Hollings offers state-of-the-art diagnostic capabilities,
therapies and surgical techniques with multidisciplinary clinics
that include surgeons, medical oncologists, radiation therapists,
radiologists, pathologists, psychologists and other specialists
equipped to the full range of cancer care. For more information,
please visit www.hcc.musc.edu.
Forward-Looking Statements
This press release contains forward-looking statements made
pursuant to the safe harbor provisions of the US 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 efficiently commercialize one or more of
its products or product candidates, the ability of the Company to
take advantage of business opportunities in the pharmaceutical
industry, uncertainties related to the regulatory process, the
specific outcome of our recently announced global resources
optimization program and the financial impact on the Company
resulting therefrom, and general changes in economic conditions.
Investors should consult the Company's quarterly and annual filings
with the Canadian and US 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.