Aeterna Zentaris Begins Second Phase 3 Trial of Cetrorelix for Benign Prostatic Hyperplasia
March 26 2008 - 7:30AM
PR Newswire (US)
QUEBEC CITY, March 26 /PRNewswire-FirstCall/ -- Aeterna Zentaris
Inc. (NASDAQ: AEZS; TSX: AEZ), 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, in the second efficacy study of its Phase 3 program in
benign prostatic hyperplasia (BPH), a non-cancerous enlargement of
the prostate. "We are very pleased to be on track with our Phase 3
clinical program for cetrorelix in BPH," said David J. Mazzo,
Ph.D., President and CEO, Aeterna Zentaris. "Based on our new
understanding of the multiple processes involved in the development
of BPH and its symptoms, cetrorelix may offer a novel therapeutic
approach to doctors and patients currently making trade-offs in
care. We look forward to continuing our investigation of cetrorelix
in this comprehensive clinical program." The study, titled,
"Cetrorelix pamoate in patients with symptomatic BPH: a
double-blind, placebo-controlled efficacy study", will involve
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 first patient randomization
commenced in April 2007, 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
will receive cetrorelix by IM injection at Week 52, 54, 78 and 80
will be followed up to Week 90. The second multi-center Phase 3
efficacy study for which first patient dosing was announced today,
will enroll approximately 400 patients in Europe. Patients in this
randomized placebo-controlled study with open-label extension, will
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, expected
to commence shortly, is an open-label, single-armed study involving
approximately 500 patients in both North America and Europe. 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 and LUTS. 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. About Cetrorelix 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' 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. News releases and additional information are
available at http://www.aezsinc.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. We disclaim any
obligation to update any such factors or to publicly announce the
result of any revisions to any of the forward-looking statements
contained herein to reflect future results, events or developments
except if we are requested by a governmental authority or
applicable law. DATASOURCE: AETERNA ZENTARIS INC. CONTACT: Jenene
Thomas, Senior Director, Investor Relations & Corporate
Communications, (908) 626-5509, ; Paul Burroughs, Media Relations,
(418) 652-8525 ext. 406,
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