Cetrorelix showed good safety and tolerability profile
Reduction of testosterone concentration was maintained above
Japanese partner Shionogi initiates Phase 2b trial
QUEBEC CITY, March 22 /CNW Telbec/ - 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
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
"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
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
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.
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
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.
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
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.
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