QUÉBEC CITY, Feb. 4, 2014 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ:
AEZS) (TSX: AEZ) (the "Company") today announced that an article on
Phase 2 results for zoptarelin doxorubicin (AEZS-108) in endometrial
cancer has been published in the February issue of the International Journal of Gynecological Cancer. Zoptarelin doxorubicin, is the Company's cytotoxic peptide conjugate
which specifically targets luteinizing hormone-releasing hormone
("LHRH") receptors. The article, "Efficacy and Safety of AEZS-108 (LHRH Agonist Linked to Doxorubicin) in
Women With Advanced or Recurrent Endometrial Cancer Expressing LHRH
Receptors: A Multicenter Phase 2 Trial (AGO-GYN5)", Emons G., Gorchev G., Harter P., Wimberger P., Stähle A., Hanker L.,
Hilpert F., Beckmann M.W., Dall P., Gründker C., Sindermann H., Sehouli
J., outlines results of this study which had been previously presented
at the European Society of Gynaecological Oncology's ("ESGO") annual
meeting in September 2011. The article is currently available at this link.
"These encouraging results were the basis for our current Phase 3 ZoptEC
(Zoptarelin doxorubicin in Endometrial Cancer) trial in women with
advanced, recurrent or metastatic endometrial cancer who have
progressed and have received one chemotherapeutic regimen with platinum
and taxane", 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
could provide the Company with a significant market opportunity."
Phase 2 Study Results and Conclusion
Forty-four patients were entered onto the study at 8 centers in Germany
and 3 centers in Bulgaria. Forty-three of these patients were eligible.
Two patients had a complete remission (5%) and 8 achieved a partial
remission (18%). Stable disease for at least 6 weeks was observed in
44%. The median time to progression (TTP) was 7 months and median
overall survival (OS) was 15 months. The most frequently reported grade
3 or 4 adverse effects were neutropenia (12%) and leucopenia (9%).
Data showed that zoptarelin doxorubicin has clinically meaningful
activity with low toxicity in women with advanced or recurrent LHRH
receptor positive endometrial cancer, supporting the principle of
receptor mediated targeted chemotherapy.
Current ZoptEC Phase 3 trial in endometrial cancer
This is an open-label, randomized, multicenter Phase 3 trial currently
being conducted under a Special Protocol Assessment, comparing
zoptarelin doxorubicin with doxorubicin as second line therapy for
advanced, recurrent or metastatic endometrial cancer. The first patient
was dosed in July 2013 and recruitment is ongoing at multiple sites in
North America, Europe and Israel. The primary efficacy endpoint is
improvement in median Overall Survival. 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.
Selected as the contract clinical development organization, Ergomed has
agreed to assume 30% (up to US$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 Phase 3 trial in
endometrial cancer under a Special Protocol Assessment, while
zoptarelin doxorubicin is also in an investigator-initiated Phase 2
trial in prostate cancer. Aeterna Zentaris owns the worldwide rights to
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
About Aeterna Zentaris Inc.
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.
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 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 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.