AEterna Zentaris Initiates First Study of Phase 3 Program with Cetrorelix in BPH - 600 Patient Trial Conducted in the United Sta
January 08 2007 - 7:00AM
PR Newswire (US)
QUEBEC CITY, Jan. 8 /PRNewswire-FirstCall/ -- AEterna Zentaris Inc.
(TSX: AEZ; Nasdaq: AEZS) today announced that the Company initiated
the first of three studies in its Phase 3 program in benign
prostatic hyperplasia (BPH) with its luteinizing hormone-releasing
hormone (LHRH) antagonist compound, cetrorelix. The first study of
the previously announced 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 at NY University School of Medicine, New York. 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 primary efficacy
endpoint of this first study is absolute change in International
Prostate Symptom Score (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. "We are very
excited to have initiated the first study of our Phase 3 program
with our flagship product candidate, cetrorelix, and look forward
to first patient dosing over the next month. We are yet another
step closer to bringing cetrorelix to market and not only have the
potential to conveniently, safely and effectively treat men who
suffer from BPH, but also create tremendous value to our
shareholders," stated Gilles Gagnon, President and Chief Executive
Officer at AEterna Zentaris. 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 will then be allocated to
cetrorelix in a double-blind, randomized, double-dummy,
placebo-controlled fashion. Patients will be administered an
intra-muscular (IM) injection of cetrorelix at Week 0, 2, 26 and 28
and will be followed up to Week 52. Then, in an open-label fashion,
patients will be administered an IM injection of cetrorelix at Week
52, 54, 78 and 80 and will be 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 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 first 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. In
2004, BPH treatment represented a market size of over US$4 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. About Cetrorelix 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 KGaA in the USA, Europe and in several other
countries, as well as in Japan through Shionogi. Cetrorelix is
currently in a pivotal clinical program for endometriosis sponsored
by the Company's partner, Solvay. In addition to the Phase 3
program in BPH, cetrorelix is in a Phase 2 program in this same
indication in Japan, sponsored by the Company's partner, Shionogi.
About AEterna Zentaris Inc. AEterna Zentaris Inc. is a late-stage
pure-play 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 http://www.aeternazentaris.com/.
Forward-Looking Statements This press release contains
forward-looking statements made pursuant to 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. DATASOURCE: AETERNA
ZENTARIS INC. CONTACT: Jenene Thomas, Senior Director, Investor
Relations & Corporate Communications, (418) 655-6420, ; Paul
Burroughs, Media Relations, (418) 652-8525 ext. 406,
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