QUÉBEC CITY, Feb. 4, 2014 /CNW
Telbec/ - 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 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 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.
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 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.