AEterna Zentaris Reports Positive Results with Cetrorelix in BPH for Japanese Phase 2a Trial
March 22 2007 - 7:30AM
PR Newswire (US)
Cetrorelix showed good safety and tolerability profile Reduction of
testosterone concentration was maintained above castration level
Japanese partner Shionogi initiates Phase 2b trial QUEBEC CITY,
March 22 /PRNewswire-FirstCall/ -- AEterna Zentaris Inc. (TSX: AEZ;
NASDAQ: AEZS) along with its Japanese partner Shionogi & Co.,
Ltd. today announced positive results for a Phase 2a trial with
cetrorelix in benign prostatic hyperplasia (BPH) initiated in 2005
in Japan. Results showed that cetrorelix, the Company's lead
luteinizing hormone-releasing hormone (LHRH) antagonist, was safe
and well tolerated at all dosage regimens. Furthermore, Japanese
patients responded to cetrorelix with a transient reduction of
testosterone concentration in blood, which did not reach or remain
at the castration level. Additionally, none of the dosage regimens
tested caused a suppression of PSA levels. Finally, data generated
with Japanese patients showed that the bioavailability of
cetrorelix was similar to that observed in non-Japanese patients.
On the basis of this study, Shionogi initiated a 300-patient phase
2b study to assess primarily the efficacy of cetrorelix in BPH in
Japanese patients. "We are very pleased with these results which
further confirm the positive data observed in prior clinical trials
in BPH with cetrorelix in non-Asian patients", said Gilles Gagnon,
President and CEO of AEterna Zentaris. "Shionogi's decision to
initiate a Phase 2b trial in BPH combined with our own ongoing
Phase 3 program with cetrorelix in this same indication, allows us
to pursue the development of cetrorelix at an international level
and represents an opportunity to potentially gain access to large
markets worldwide." Nippon Kayaku, the Company's other Japanese
partner, has terminated its agreement with respect to their
collaboration with the development of cetrorelix pamoate to focus
solely in oncology. About the Phase 2a trial The completed Phase 2a
trial with cetrorelix in BPH was designed to evaluate primarily
pharmacokinetics and safety (systemic and local tolerability) in
Japanese subjects, whereas evaluation of efficacy was only
exploratory. In this multicenter, placebo-controlled and randomized
trial, the sustained release formulation cetrorelix pamoate was
administered intramuscularly as single or multiple dosing
schedules. A total of 50 patients were included in 5 dosing groups
corresponding to single administration of 30 mg, 60 mg or 90 mg
cetrorelix and multiple administration of 60 mg and 90 mg, 3 times
8 weeks apart. The observation period was up to 32 weeks in the
multiple administration dosing groups. Results The pharmacokinetic
data generated with Japanese patients showed that the
bioavailability of cetrorelix after intramuscular cetrorelix
pamoate injection is similar to that observed in non-Japanese
patients. Similarly, the Japanese patients responded to cetrorelix
with a transient reduction of testosterone concentration in blood,
which did not reach or remain at the castration level.
Intramuscular injection of cetrorelix pamoate was safe and well
tolerated at all dosages tested, both locally and systemically.
None of the dosage regimens tested caused a suppression of PSA
levels which is important considering that a treatment-related
suppression would prevent the use of this marker for the routine
monitoring of BPH patients for the potential development of
prostate cancer. The sizes per dosage group were too small to
evaluate efficacy trends for statistical significance. 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 and the University of 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 USA, Europe and
in several other countries, as well as in Japan through Shionogi.
AEterna Zentaris is currently conducting a large Phase 3 program
with cetrorelix in BPH while the Company's partner, Solvay is
sponsoring a pivotal clinical program for endometriosis with this
same compound. About AEterna Zentaris Inc. AEterna Zentaris Inc. is
a late-stage 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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