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/m(2)) in the Phase 1 portion. Six patients that were administered the 210
mg/m(2 )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
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.
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.