QUÉBEC CITY, Dec. 29, 2014 /CNW
Telbec/ - Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) (the
"Company") today announced that an article on final data for the
Phase 1 portion of the ongoing Phase 1/2 trial in prostate cancer
with zoptarelin doxorubicin (formerly AEZS-108), a hybrid molecule
composed of a synthetic peptide carrier and a well-known
chemotherapy agent, doxorubicin, has been published in the December
issue of Clinical Cancer Research. The article outlines data
previously disclosed in June 2013 at
the American Society of Clinical Oncology's ("ASCO") Annual
Meeting, which demonstrated the compound's safety profile and
promising anti-tumor activity in heavily pre‑treated men with
castration- and taxane-resistant prostate cancer. These results led
to the current investigator-driven Phase 2 portion in this same
indication under the supervision of lead investigator, Jacek Pinski, MD, PhD, of the USC Norris Comprehensive Cancer Center. Titled,
"Phase I, Dose-Escalation Study of the Targeted Cytotoxic LHRH
Analog AEZS-108 in Patients with Castration- and Taxane-Resistant
Prostate Cancer", Liu SV, Tsao-Wei DD, Xiong S, Groshen
S, Dorff TB, Quinn DI, Tai YC, Engel J, Hawes D, Schally AV, Pinski
J., the article is available at this link: Clin Cancer Res.
David Dodd, Chairman and CEO of
Aeterna Zentaris stated, "The Phase 1 portion data are very
encouraging and we look forward to further results from the current
Phase 2 portion of this investigator‑driven trial. Because
luteinizing hormone-releasing hormone receptors are expressed in a
great number of prostate cancers, we believe that zoptarelin
doxorubicin, which specifically targets those receptors, may
represent a novel targeted treatment for men with this disease.
Expansion into prostate cancer with zoptarelin doxorubicin after
positive Phase 2 results in endometrial and ovarian cancer, is
further demonstration of the potential of this innovative compound
in a variety of cancer indications which affect men as well as
women, and could provide the Company with a significant market
opportunity."
Phase 1 Results and Conclusions
Luteinizing hormone-releasing hormone ("LHRH") receptors are
expressed on the cell membrane of many tumors, including prostate
cancer ("PC"). This Phase I study with zoptarelin doxorubicin which
targets these LHRH receptors, determined the maximum tolerated dose
("MTD") of this agent in men with taxane- and castration-resistant
PC while providing additional information on its safety profile and
efficacy. Zoptarelin doxorubicin was administered as an intravenous
infusion every 21 days until progression or unacceptable toxicity
in cohorts of 3 or 6 patients until the maximum tolerated dose
("MTD") was reached. The MTD of zoptarelin doxorubicin in this
cohort was 210 mg/m2, which was lower than that seen in
a Phase I study conducted in women with endometrial or ovarian
cancers. The dose limiting toxicity was persistent neutropenia.
Three patients had a prostate-specific antigen ("PSA") response
with an additional 10 patients maintaining PSA stable disease. Of
the 10 patients evaluable by RECIST criteria, 9 achieved stable
disease. These findings show that zoptarelin doxorubicin has an
acceptable safety profile and a signal of efficacy, lowering PSA in
heavily pretreated patients with prostate cancer, and that
internalization of zoptarelin doxorubicin in PC circulating tumor
cells may be a viable pharmacodynamic marker.
Current Phase 2 Portion of the Study
This is a single-arm Simon Optimum design Phase 2 study of
zoptarelin doxorubicin involving up to 37 patients with pre‑treated
castration-and taxane-resistant prostate cancer, using the dose
selected (210 mg/m2) in the Phase 1 portion. The primary
endpoint is to evaluate the clinical benefit of zoptarelin
doxorubicin for these patients. Clinical benefit will be defined as
non-progression at 12 weeks with no dose‑limiting toxicity or other
toxicity requiring termination of treatment.
More information on the current Phase 2 portion of the trial is
available at this link: NCT01240629.
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. In
addition to the ongoing investigator-driven Phase 2 trial in
prostate cancer, the Company is currently conducting a ZoptEC
(Zoptarelin doxorubicin in Endometrial Cancer)
Phase 3 trial in women with advanced, recurrent or metastatic
endometrial cancer. Aeterna Zentaris owns the worldwide rights (ex.
China, Hong Kong and Macau) to this compound.
About Prostate Cancer
Prostate cancer is the most frequently diagnosed cancer in men
aside from skin cancer. An estimated 233,000 new cases of prostate
cancer will occur in the U.S. during 2014. With an estimated 29,480
deaths in 2014, prostate cancer is the second-leading cause of
cancer death in men.
About Aeterna Zentaris Inc.
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.
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 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.