AEterna Zentaris Announces First Patient Dosing for Safety Trial of Phase 3 Program with Cetrorelix in Benign Prostatic Hyperpla
May 14 2008 - 7:30AM
PR Newswire (US)
QUEBEC CITY, May 14 /PRNewswire-FirstCall/ -- AEterna Zentaris Inc.
(NASDAQ: AEZS; TSX: AEZ), a global biopharmaceutical company
focused on endocrine therapy and oncology, today reported dosing
has commenced in the safety study of the Company's Phase 3 program
with cetrorelix in benign prostatic hyperplasia (BPH). Cetrorelix,
a novel investigational luteinizing hormone-releasing hormone
(LHRH) antagonist, is the Company's flagship product candidate.
This 500-patient safety trial is the third of three Phase 3 studies
- planned to enroll a total of 1,500 patients - to define the role
of cetrorelix in the treatment of BPH, a non-cancerous enlargement
of the prostate affecting millions of men. "With this additional
study, all three trials of our Phase 3 program are now in full
gear. 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," said Paul Blake, M.D., Senior
Vice President and Chief Medical Officer at AEterna Zentaris. The
safety study titled, "Cetrorelix pamoate in patients with
symptomatic BPH: an open labeled safety and efficacy assessment
study", will involve approximately 500 patients in North America
and Europe, and 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 will receive cetrorelix pamoate by intra-muscular (IM)
injection at weeks 0 and 2, and will be 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 will include approximately
1,500 men with symptomatic BPH in the United States, Canada and
Europe. One Phase 3 efficacy trial, 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 will be followed up to
Week 90. A second, similarly designed ongoing (first patient dosing
announced on March 26, 2008) multi-center Phase 3 efficacy study,
being led by Prof. Frans M.J. Debruyne, M.D., Ph.D., from The
Netherlands, will enroll approximately 400 patients in Europe. The
third Phase 3 trial, for which first patient dosing was announced
today, is an open-label, single-armed multi-center safety study
involving approximately 500 patients in both North America and
Europe, 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: Dennis
Turpin, CA, Senior Vice President and Chief Financial Officer,
(908) 626-5503, ; Media Relations: Paul Burroughs, Director of
Communications, (418) 652-8525 ext. 406,
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