QUEBEC CITY, Oct. 1, /CNW Telbec/ - AEterna Zentaris Inc. (NASDAQ: AEZS;
TSX: AEZ), a global biopharmaceutical company focused on endocrine therapy and
oncology, today reported the completion of patient recruitment for the
Company's second efficacy trial of its Phase 3 program in benign prostatic
hyperplasia (BPH), a non-cancerous enlargement of the prostate, with its
flagship product candidate, cetrorelix, a Luteinizing Hormone Releasing
Hormone (LHRH) antagonist. This second efficacy study involves approximately
400 patients, mainly in Europe.
"We are very pleased to have completed patient recruitment for this
second efficacy trial as scheduled. Our Phase 3 program is progressing well
and remains on track with first results expected for the third quarter of
2009," said Paul Blake MD, Senior Vice President and Chief Medical Officer of
AEterna Zentaris. "We firmly believe that cetrorelix's novel therapeutic
approach could lead to a more efficacious and convenient treatment for the
millions of men with BPH."
The study, titled, "Cetrorelix pamoate in patients with symptomatic BPH:
a double-blind, placebo-controlled efficacy study", involves approximately
400 patients, and will assess an intermittent dosage regimen of cetrorelix as
a potential safe and tolerable treatment providing prolonged improvement in
BPH-related signs and symptoms. This Phase 3 trial, conducted in Europe under
the supervision of lead investigator, Prof. Dr. Frans M.J. Debruyne, MD, of
the Andros Mannenkliniek, Arnhem, The Netherlands, is part of the Company's
Phase 3 program with cetrorelix being studied in approximately 1,500 patients
in North America and Europe in men with symptomatic BPH.
About the Phase 3 Program with Cetrorelix in BPH
The first multi-center efficacy study for which patient recruitment was
completed in April 2008, is currently being conducted primarily in the United
States and Canada, with additional sites in Europe and involves approximately
600 patients under the supervision of lead investigator, Herbert Lepor, MD,
Professor at NY University School of Medicine, New York. 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 randomly allocated to cetrorelix or placebo in
a double-blind fashion. Patients are administered cetrorelix by intra-muscular
(IM) injection at Week 0, 2, 26 and 28 and are followed up to Week 52. Then,
in an open-label extension, patients receive cetrorelix by IM injection at
Week 52, 54, 78 and 80 and are followed up to Week 90.
The second multi-center Phase 3 efficacy study for which patient
recruitment completion was announced today, involves approximately
400 patients, mainly in Europe. Patients in this randomized placebo-controlled
study with open-label extension, receive cetrorelix according to similar
dosing regimens used in the first study.
The primary endpoint for both North American and European efficacy
studies is absolute change in IPSS between baseline and Week 52. Other
efficacy endpoints include additional measures of BPH symptom progression and
the need for BPH-related surgery. Safety endpoints include changes in sexual
function. Other important endpoints include plasma changes in levels of
testosterone, and assessment of other adverse events.
The third study in the Phase 3 program, a multi-center safety study, for
which patient recruitment started in May 2008, is an ongoing open-label,
single-armed study involving approximately 500 patients in both North America
About Benign Prostatic Hyperplasia
Benign prostatic hyperplasia (BPH) is one of the most common diseases of
aging men - affecting more than 20 million men in the United States - but its
etiology is far from being completely understood. Data from ongoing research
suggest BPH and lower urinary tract symptoms (LUTS) are more complex
conditions than once thought. While previous research on BPH etiology tended
to focus on testosterone and other hormones, more recent research suggests
other factors - including inflammation, various growth factors, and
adrenoreceptors - actually may play a greater role in the development of BPH
BPH is associated with LUTS, including: frequent urination, a sudden,
uncontrollable urge to urinate, waking at night to urinate (nocturia),
difficulty starting a urine stream (hesitancy and straining), decreased
strength of the urine stream (weak flow), feeling that the bladder is not
completely empty, an urge to urinate again soon after urinating and pain
during urination (dysuria). Currently available therapies may improve symptoms
to some degree, but often come with sexual and other side effects.
Cetrorelix pamoate is an investigational agent that has shown in Phase 2
studies to provide fast and long lasting relief of BPH symptoms and was well
tolerated, with a low incidence of sexual side effects. Cetrorelix is part of
AEterna Zentaris' Luteinizing Hormone Releasing Hormone (LHRH) antagonist
therapeutic approach. This peptide-based active substance was developed by the
Company in cooperation with Nobel Prize winner Prof. Andrew Schally, currently
of the U.S. Veterans Administration in Miami.
Cetrorelix acetate 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 Serono (now 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 being
studied in a Phase 2b program in this same indication in Japan, sponsored by
the Company's partner, Shionogi.
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.
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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
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