AEterna Zentaris Completes Patient Recruitment for Safety Trial of Phase 3 Program with Cetrorelix in Benign Prostatic Hyperplas
December 11 2008 - 7:30AM
PR Newswire (US)
QUEBEC CITY, Dec. 11 /PRNewswire-FirstCall/ -- AEterna Zentaris
Inc. (NASDAQ: AEZS; TSX: AEZ), a global biopharmaceutical company
focused on endocrine therapy and oncology, today reported it has
reached its goal of recruiting 500 patients for the safety study of
the Phase 3 program in benign prostatic hyperplasia (BPH) with its
flagship product candidate, cetrorelix, a novel investigational
luteinizing hormone-releasing hormone (LHRH) antagonist. This
safety trial, the third of three Phase 3 studies - involving a
total of over 1,500 patients -will define the role of cetrorelix in
the treatment of BPH, a non-cancerous enlargement of the prostate
affecting millions of men. "With today's announcement, all three
trials of our Phase 3 program in BPH with cetrorelix are now fully
recruited according to our scheduled timelines. We now look forward
to the disclosure of the first efficacy results in the third
quarter of 2009 which could be followed by an NDA in 2010," said
Paul Blake, M.D., Senior Vice President and Chief Medical Officer
at AEterna Zentaris. "Furthermore, this milestone brings us one
step closer to our goal of providing a novel, safe and efficient
therapeutic approach to the millions of men suffering from BPH."
The safety study titled, "Cetrorelix pamoate in patients with
symptomatic BPH: an open-labeled safety and efficacy assessment
study", being conducted in North America, will assess an
intermittent dosage regimen of cetrorelix pamoate as a potential
safe and tolerable treatment providing prolonged improvement in
BPH-related signs and symptoms. Patients receive cetrorelix pamoate
by intra-muscular (IM) injection at Weeks 0 and 2, and are followed
up to Week 26. The main endpoint is the incidence of possibly
drug-related adverse events. About Cetrorelix Cetrorelix is part of
AEterna Zentaris' LHRH antagonist therapeutic approach that has
demonstrated in Phase 2 studies to provide fast and long-lasting
relief of BPH symptoms while being well tolerated, with a low
incidence of sexual side effects. Cetrorelix peptide-based drugs
were 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 ovarian stimulation/assisted reproductive technologies)
in Europe, the U.S. and Japan. It was launched on the market
through Serono (now Merck Serono) in the United States, Europe and
in several other countries, as well as in Japan through Shionogi.
About the Cetrorelix Phase 3 Program in BPH Cetrorelix pamoate is
being studied in three Phase 3 trials which include over 1,500 men
with symptomatic BPH in the United States, Canada and Europe. The
first Phase 3 efficacy trial conducted primarily in the United
States and Canada and with additional sites in Europe, involves
approximately 600 patients (completion of patient recruitment
announced on April 15, 2008) and is being led by Herbert Lepor,
M.D., Professor and Martin Spatz Chairman of Urology, New York
University School of Medicine, New York. In the trial, patients
enter a no-treatment run-in observation period to confirm severity
and stability of voiding symptoms based on the International
Prostate Symptom Score (I-PSS). 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 and will be followed up
to Week 90. A second, similarly designed ongoing multi-center Phase
3 efficacy study (completion of patient recruitment announced on
October 1, 2008), led by Prof. Frans M.J. Debruyne, M.D., Ph.D.,
from The Netherlands, involves approximately 400 patients, mainly
in Europe. The third Phase 3 trial (completion of patient
recruitment was announced today) is an open-label, single-armed
multi-center safety study involving approximately 500 patients in
North America, and is being led by Joel Kaufman, M.D., Associate
Clinical Professor of Urology, University of Colorado School of
Medicine, Denver, Colorado, and Urology Research Options, Aurora,
Colorado. The primary endpoint for both North American and European
efficacy studies is the change in I-PSS 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
cetrorelix Phase 3 program is based on comprehensive clinical
practice guidelines to ensure quality control, including input from
expert advisors on study design, publishing results in
peer-reviewed journals and discussion of the studies with
regulatory agencies. 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 its associated 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 may play a greater role in the development of BPH and
LUTS - including inflammation, various growth factors, and
adrenoreceptors. BPH-associated LUTS include frequent urination
and/or urgent need to urinate, waking at night to urinate
(nocturia), difficulty starting urination and/or weak urinary
stream, and feeling that the bladder is not completely empty after
urination. While current therapies provide some efficacy in BPH
they are often associated with troublesome sexual side effects.
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: Investor
Relations: Ginette Vallieres, Investor Relations, (418) 652-8525
ext. 265, ; Media Relations: Paul Burroughs, Coordinator Director
of Communications, (418) 652-8525 ext. 406,
Copyright