AEterna Zentaris Reports First Patients Treated with Cetrorelix for Phase 3 Program in BPH
April 19 2007 - 8:30AM
PR Newswire (US)
All amounts are in US dollars QUEBEC CITY, April 19
/PRNewswire-FirstCall/ -- 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 billion market."
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 http://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. 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 Serono in the U.S., Europe and in several
other countries, as well as in Japan through Shionogi. 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 by Solvay. 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
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,
Copyright