Aeterna Zentaris Announces Initiation of Phase 2 Portion of Phase
1/2 Trial with AEZS-108 in Prostate Cancer
QUÉBEC CITY, Nov. 12, 2012
/PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ)
(the "Company") today announced the start of the Phase 2 portion of
its ongoing Phase 1/2 study in castration- and taxane-resistant
prostate cancer (CRPC) with AEZS-108. The trial on the Company's
targeted cytotoxic luteinizing hormone-releasing hormone (LHRH)
analog, AEZS-108, is being supported by a three-year US$1.6 million grant from the National Institutes
of Health to Jacek Pinski, MD, PhD,
Associate Professor of Medicine at the Norris Comprehensive Cancer
Center of the University of Southern
California.
Preliminary data for the Phase 1 portion of this trial,
presented in February 2012 at the
American Society of Clinical Oncology Genitourinary Cancers
Symposium, demonstrated that AEZS-108 was well tolerated and
demonstrated early evidence of antitumor activity in men with CRPC.
The poster on these preliminary data can be viewed on line through
the following link. Final Phase 1 data are expected to be presented
at an upcoming conference in 2013.
Dr. Pinski stated, "AEZS-108 has been very well tolerated in
this heavily pre-treated population, and its efficacy, so far, is
impressive. We are fully committed to the Phase 2 portion of the
study as shown with the opening of additional sites at the
Los Angeles County Hospital,
West Los Angeles and Pasadena clinics."
Juergen Engel, PhD, President and
CEO of Aeterna Zentaris said, "We would like to congratulate Dr.
Pinski and his colleagues on the progress made with this study.
AEZS-108 is a key element of our personalized medicine approach in
oncology, and we look forward to results for the Phase 2 portion of
this trial, as AEZS-108 could offer a novel targeted treatment for
men suffering from prostate cancer."
Phase 2 Portion of the Phase 1/2 Study
This is a single-arm Simon Optimum design Phase 2 study
involving up to 37 patients with pre-treated CRPC, using the dose
selected (210 mg/m2) in the Phase 1 portion. Six
patients that were administered the 210 mg/m2 dose in
the Phase 1 portion of the trial, have already been included in the
Phase 2 portion.
For the Phase 2 portion, patients receive AEZS-108 intravenously
over 2 hours in repeating 21 day cycles, until progression of the
disease, unacceptable toxicity or patient withdrawal. If clinical
benefit is observed, up to 6 cycles will be administered. Patient's
continuation beyond 6 cycles is left at the discretion of the
Principal Investigator. Premedication includes dexamethasone
8 mg. Maximal Prostate Specific Antigen (PSA) response is
calculated using PSA Working Group 2 guidelines. Response
Evaluation Criteria in Solid Tumors (RECIST, v. 1.1) is
used to assess response for patients with measurable disease.
The primary endpoint of the Phase 2 portion is to evaluate the
clinical benefit of AEZS-108 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.
Secondary endpoints include toxicity, time to RECIST and PSA
progression, RECIST response rate for patients with measurable
disease, PSA response rate, pain palliation, and overall survival.
In addition, there will be correlative studies to investigate
potential predictors of response and outcomes.
About AEZS-108 (zoptarelin doxorubicin acetate)
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. AEZS-108 is the first
intravenous drug in a clinical study that directs the chemotherapy
agent specifically to LHRH-receptor expressing tumors, resulting in
more targeted treatment with less damage to healthy tissue. The
product has successfully completed Phase 2 studies for the
treatment of endometrial and ovarian cancer, and is also in Phase 2
trials in prostate and bladder cancer. The Company is currently
planning a Phase 3 trial in endometrial cancer. AEZS-108 has been
granted orphan-drug designation by the U.S. Food and Drug
Administration and orphan medicinal product designation from the
European Medicines Agency for the treatment of ovarian cancer. An
Investigational New Drug in the U.S. is in place for the treatment
of prostate, bladder and triple-negative breast cancer. Aeterna
Zentaris owns the worldwide rights to AEZS-108.
About Aeterna Zentaris
Aeterna Zentaris is an oncology and endocrinology drug
development company currently investigating treatments for various
unmet medical needs. The Company's pipeline encompasses compounds
at all stages of development, from drug discovery through to
marketed products. For more information please 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.