AEterna Zentaris to Initiate Phase 3 Program with Cetrorelix in BPH
November 29 2006 - 7:30AM
PR Newswire (US)
IND accepted by FDA First study to be initiated before year-end
QUEBEC CITY, Nov. 29 /PRNewswire-FirstCall/ -- AEterna Zentaris
Inc. (TSX: AEZ; Nasdaq: AEZS) today announced the Company's plan to
initiate its Phase 3 program in benign prostatic hyperplasia (BPH)
before year-end with its luteinizing hormone-releasing hormone
(LHRH) antagonist compound, cetrorelix, after the Company's
Investigational New Drug Application (IND) was accepted by the U.S.
Food and Drug Administration (FDA). The first study of this Phase 3
program titled, "Cetrorelix pamoate intermittent IM dosage regimens
in patients with symptomatic BPH: a 1 year placebo-controlled
efficacy study and long-term safety assessment", will assess an
intermittent dosage regimen of cetrorelix as a potential safe and
tolerable treatment providing prolonged improvement in BPH-related
signs and symptoms, under the supervision of lead investigator,
Herbert Lepor, M.D., Professor at NY University School of Medicine,
New York. This first study, involving approximately 600 patients,
is part of an extensive Phase 3 program enrolling a total of about
1,500 patients, which will include other large safety and efficacy
studies conducted in North America and Europe. "Cetrorelix has
shown promising and compelling results in our prior extensive Phase
2 program, and we are now very excited about the possibility of
bringing to market a safe and novel treatment for the millions of
men suffering from BPH," said Dr. Jurgen Engel, Executive Vice
President, Global R&D and Chief Operating Officer at AEterna
Zentaris. "We believe cetrorelix has significant potential in this
indication especially with its intermittent mode of administration
of only two treatments by intra-muscular injection repeated after a
six-month interval, contrary to daily oral intake for current
treatments, thus alleviating the issue of patient compliance and
convenience. Assuming conclusive results for this Phase 3 program,
we would expect to file an NDA by mid-2009." Gilles Gagnon, AEterna
Zentaris President and Chief Executive Officer added, "We are very
excited to be initiating our Phase 3 program with our flagship
product candidate, cetrorelix. We are also proud of our execution
on a development front as this represents a critical strategic
milestone in the evolution of our Company into a late-stage
biopharmaceutical company. Considering the vast experience we have
with this compound and the positive data we have seen thus far, we
are confident in our abilities to bring this compound to an NDA
filing and, given its known attributes, its potential to
successfully penetrate a US$4 billion plus market such as BPH."
About the Phase 3 Program with Cetrorelix in BPH In the first
multi-center study, patients will 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 will then be allocated to cetrorelix in a
double-blind, randomized, double-dummy, placebo-controlled fashion.
Patients will be administered an intra-muscular (IM) injection of
cetrorelix at Week 0, 2, 26 and 28 and will be followed up to Week
52. Then, in an open-label fashion, patients will be administered
an IM injection of cetrorelix at Week 52, 54, 78 and 80 and will be
followed up to Week 90. The primary efficacy endpoint of this first
study is absolute change in IPSS between baseline before beginning
treatment and Week 52, while safety endpoints include changes in
sexual function as well as BPH symptom progression equal to or more
than 4 points and/or acute urinary retention and/or need for BPH
related surgery. Other important endpoints consist of plasma levels
of testosterone and changes in bone mineral density. This first
study will be conducted across the United States and Canada and
will involve approximately 600 patients under the supervision of
lead investigator, Herbert Lepor, M.D., Professor at NY University
School of Medicine, New York. Dr. Lepor was the lead investigator
for a prior Phase 2 trial with cetrorelix in BPH. The second
multi-center study of this Phase 3 program is expected to be
initiated in the first half of 2007 and will enroll approximately
300 patients in Europe. Patients will receive cetrorelix according
to similar administration regimens used in the first study. The
third multi-center study of this Phase 3 program, which is expected
to be initiated in the second half of 2007, will be an open-label,
single-armed safety study involving approximately 600 patients in
both North America and Europe. About Benign Prostatic Hyperplasia
BPH is characterized by an abnormal benign growth of the prostatic
tissues caused by testosterone. Symptoms linked to BPH include pain
while urinating and frequent urges to urinate during the night and
sometimes, kidney problems. In some cases, if left untreated, BPH
may develop into prostate cancer. BPH affects more than 50% of men
60 years and over, with approximately 56 million cases in the U.S.,
Europe and Japan. In 2004, BPH treatment represented a market size
of over US$4 billion. Contrary to most of the present treatments
for BPH, cetrorelix is not associated with side-effects such as
erectile dysfunction, loss of libido and chemical castration.
According to Decision Resource, cetrorelix is currently the most
advanced LHRH-antagonist in development for the treatment of BPH.
About Cetrorelix 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 Professor Andrew Schally of the U.S. Veterans
Administration in Miami. Cetrorelix 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 S.A. in the USA, Europe and in several other
countries, as well as in Japan through Shionogi. Cetrorelix is
currently in a pivotal clinical program for endometriosis sponsored
by the Company's partner, Solvay. In addition to the Phase 3
program in BPH, cetrorelix is in a Phase 2 program in this same
indication in Japan, sponsored by the Company's partner, Shionogi.
About the Cetrorelix Successful Phase 2 Program Cetrorelix has
shown to adequately suppress the formation of the male sex hormone
testosterone, which plays a principal role in cell growth of the
prostate. Since cell growth is stopped, surgical removal of the
prostate might be avoided. All studies performed so far with
cetrorelix in patients with symptomatic BPH, revealed an
improvement in symptoms as assessed primarily by the IPSS and an
increase in urinary peak flow rate. Studies have also shown the
excellent safety and tolerability profile of cetrorelix. Cetrorelix
has successfully completed a broad 7-Phase 2 program in BPH,
endometriosis, and uterine myoma. This extensive clinical program
involved 735 patients and yielded statistically significant and
medically important results. Rapid and durable responses were
observed without chemical castration and cetrorelix proved to have
an excellent safety and tolerability profile. Overall, cetrorelix
has shown to have a fast onset of action allowing for a shorter
treatment period, which could translate into an
intermittent/chronic therapy. Such long treatment-free intervals
are actually supported by the results derived from multiple Phase 2
placebo-controlled studies. About AEterna Zentaris Inc. AEterna
Zentaris Inc. is a growing 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.aeternazentaris.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. DATASOURCE: AETERNA
ZENTARIS INC. CONTACT: Media Relations: Paul Burroughs, (418)
573-8982, ; Investor Relations: Jenene Thomas, (418) 655-6420,
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