All amounts are in US dollars
QUEBEC CITY, April 19 /CNW Telbec/ - AEterna Zentaris Inc. (TSX: AEZ;
Nasdaq: AEZS), a global biopharmaceutical company focused on endocrine therapy
and oncology, today reported dosing has commenced with its flagship product
candidate, cetrorelix, the Company's lead luteinizing hormone-releasing
hormone (LHRH) antagonist compound, in the first study of its Phase 3 program
in benign prostatic hyperplasia (BPH). As previously announced, the first
study of the Phase 3 program titled, "Cetrorelix pamoate intermittent IM
dosage regimens in patients with symptomatic BPH: a 1-year placebo-controlled
efficacy study and long-term safety assessment", will assess an intermittent
dosage regimen of cetrorelix as a potential safe and tolerable treatment
providing prolonged improvement in BPH-related signs and symptoms, under the
supervision of Lead Investigator, Herbert Lepor, M.D., Professor and Martin
Spatz Chairman of Urology, at the New York University School of Medicine.
"We are very excited to report our first patients being treated with
cetrorelix in our extensive Phase 3 program in BPH," stated David J. Mazzo,
Ph.D., President and CEO of AEterna Zentaris. "We expect recruitment to
progress swiftly over the remainder of the year as the vast majority of our 10
centers in Canada and 30 centers in the United States will be up and running
by the end of the month. This event also marks a key milestone in our drug
development strategy as it brings our flagship product candidate yet another
step closer to an NDA filing. We strongly believe that given its known
attributes, cetrorelix has the potential to successfully penetrate a $4 plus
Herbert Lepor, M.D., Professor and Martin Spatz Chairman of Urology at
the NYU School of Medicine and Lead Investigator of the Phase 3 program added,
"Having been involved in BPH research for more than 20 years and considering
the strong prior data on cetrorelix, I am pleased that the Phase 3 program for
cetrorelix is advancing on course and thrilled to continue my involvement with
this novel compound leading its class in development. I believe cetrorelix has
a high probability of ultimately providing a convenient, safe and effective
treatment for the millions of men suffering from BPH. "
This first study, involving approximately 600 patients, is part of an
extensive Phase 3 program enrolling a total of about 1,500 patients, which
will include other large safety and efficacy studies conducted in North
America and Europe.
The trial is open for patient recruitment. If interested in more
information about the trial, please visit www.clinicaltrials.gov. The
Identifier for this trial is NCT00449150.
About the Phase 3 Program with Cetrorelix in BPH
In the first multi-center study, patients enter a 4-week run-in
no-treatment observation period to confirm severity and stability of voiding
symptoms based on the International Prostate Symptom Score (IPSS). Patients
are then allocated to cetrorelix in a double-blind, randomized, double-dummy,
placebo-controlled fashion. Patients are administered an intra-muscular (IM)
injection of cetrorelix at Week 0, 2, 26 and 28 and are followed up to Week
52. Then, in an open-label fashion, patients are administered an IM injection
of cetrorelix at Week 52, 54, 78 and 80 and are followed up to Week 90.
The primary efficacy endpoint of this first study is absolute change in
IPSS between baseline before beginning treatment and Week 52, while safety
endpoints include changes in sexual function as well as BPH symptom
progression equal to or more than 4 points and/or acute urinary retention
and/or need for BPH related surgery. Other important endpoints consist of
plasma levels of testosterone and changes in bone mineral density.
This first study is being conducted across the United States and Canada
and involves approximately 600 patients under the supervision of lead
investigator, Herbert Lepor, M.D., Professor at NY University School of
Medicine, New York. Dr. Lepor was the lead investigator for a prior Phase 2
trial with cetrorelix in BPH.
The second multi-center study of this Phase 3 program is expected to be
initiated in the second half of 2007 and will enroll approximately 300
patients in Europe. Patients will receive cetrorelix according to similar
administration regimens used in the first study.
The third multi-center study of this Phase 3 program, which is expected
to be initiated in the second half of 2007, will be an open-label,
single-armed safety study involving approximately 600 patients in both North
America and Europe.
About Benign Prostatic Hyperplasia
BPH is characterized by an abnormal benign growth of the prostatic
tissues caused by testosterone. Symptoms linked to BPH include pain while
urinating and frequent urges to urinate during the night and sometimes, kidney
problems. In some cases, if left untreated, BPH may develop into prostate
cancer. BPH affects more than 50% of men 60 years and over, with approximately
56 million cases in the U.S., Europe and Japan. As of 2004, BPH treatment
represented a market size of over $2.6 billion. Contrary to most of the
present treatments for BPH, cetrorelix is not associated with side-effects
such as erectile dysfunction, loss of libido and chemical castration.
According to Decision Resource, cetrorelix is currently the most advanced
LHRH-antagonist in development for the treatment of BPH.
Cetrorelix is part of AEterna Zentaris' LHRH antagonist therapeutic
approach. This peptide-based active substance was developed by the Company in
cooperation with Nobel Prize winner Professor Andrew Schally of the U.S.
Veterans Administration in Miami.
Cetrorelix is marketed under the brand name Cetrotide(R), the first LHRH
antagonist approved for therapeutic use as part of in vitro fertilization
programs (controlled ovulation stimulation/assisted reproductive technologies)
in Europe, the USA and Japan. It was launched on the market through Merck
Serono in the U.S., Europe and in several other countries, as well as in Japan
In addition to the Phase 3 program in BPH, cetrorelix is also in a Phase
2 program in this same indication in Japan, sponsored by the Company's
partner, Shionogi as well as in a clinical program for endometriosis sponsored
About AEterna Zentaris Inc.
AEterna Zentaris Inc. is a global biopharmaceutical company focused on
endocrine therapy and oncology, with proven expertise in drug discovery,
development and commercialization.
News releases and additional information are available at
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the safe harbor provisions of the U.S. Securities Litigation Reform Act of
1995. Forward-looking statements involve known and unknown risks and
uncertainties, which 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 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 the 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.
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