AEterna Zentaris' Partner, Spectrum, Provides Update on Ozarelix in Benign Prostatic Hyperplasia
April 22 2008 - 5:00PM
PR Newswire (US)
QUEBEC CITY, April 22 /PRNewswire-FirstCall/ -- AEterna Zentaris
Inc. (NASDAQ: AEZS; TSX: AEZ), a global biopharmaceutical company
focused on endocrine therapy and oncology, today announced that its
partner, Spectrum Pharmaceuticals (NASDAQ:SPPI), released Phase 2b
results for ozarelix, a luteinizing hormone-releasing hormone
(LHRH) antagonist in benign prostatic hyperplasia (BPH). Spectrum
indicated that ozarelix demonstrated sufficient clinical activity
to justify its continued development in BPH. Based on these
results, Spectrum is planning to submit a protocol to the FDA for
the next study of ozarelix in BPH. "We are pleased that Spectrum is
proceeding with plans for their upcoming study," stated Paul Blake,
M.D., Senior Vice President and Chief Medical Officer of AEterna
Zentaris. "AEterna Zentaris remains committed about the potential
of LHRH antagonists for BPH, particularly for our lead candidate
cetrorelix, which has produced robust and consistent findings in
Phase 2 trials and is currently being evaluated in three
multi-center Phase 3 trials in the United States, Canada and
Europe." He said that results from the cetrorelix Phase 3 program
are expected in the third quarter of 2009. About Ozarelix and
Partnerships Ozarelix is an injectable fourth generation LHRH
antagonist administered as an intramuscular injection. In August
2004, AEterna Zentaris granted Spectrum Pharmaceuticals an
exclusive license to develop and market ozarelix for all potential
indications in North America (including Canada and Mexico) and
India, while AEterna Zentaris retained exclusive rights to the rest
of the world. In addition, Spectrum was granted the right to
receive 50% of any upfront and milestone payments, royalties and/or
profits from sales of ozarelix in Japan. On July 26, 2006 AEterna
Zentaris licensed the Japanese rights for all ozarelix potential
oncology indications to Nippon Kayaku, a key player in the Japanese
oncology market. About Cetrorelix Cetrorelix pamoate is an
investigational agent 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 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 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 (which are fully enrolled) 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 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. A second, similarly designed multi-center
Phase 3 efficacy study, being led by Professor Frans M.J. Debruyne,
M.D., Ph.D., from the Netherlands, will enroll approximately 400
patients in Europe. The third Phase 3 trial 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 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
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 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) 626-5517, ; Media Relations: Paul Burroughs, Director of
Communications, (418) 652-8525 ext. 406,
Copyright