AEterna Zentaris Reports Statistically Significant Positive Phase II Data on Cetrorelix in Benign Prostatic Hyperplasia
October 07 2004 - 8:30AM
PR Newswire (US)
AEterna Zentaris Reports Statistically Significant Positive Phase
II Data on Cetrorelix in Benign Prostatic Hyperplasia Broad,
seven-study Phase II program on cetrorelix in BPH, endometriosis
and uterine myoma now successfully completed. QUEBEC CITY, Oct. 7
/PRNewswire-FirstCall/ -- AEterna Zentaris Inc. (TSX: AEZ; NASDAQ:
AEZS) today announced statistically significant positive results
from a randomized, double-blind, placebo-controlled Phase II trial
designed to evaluate different dosage regimens of a depot
formulation of cetrorelix, a luteinizing hormone-releasing hormone
(LHRH) antagonist, in 250 patients with symptomatic benign
prostatic hyperplasia (BPH). These new data demonstrate a
dose-dependent, durable and statistically significant (p less than
0.001) improvement of clinical symptoms characteristic of BPH,
including IPSS (International Prostate Symptom Score), at all
dosages except the lowest, as well as an excellent safety and
tolerability profile. These positive results are consistent with
data from earlier studies and provide the basis for further
development of cetrorelix in BPH through collaboration with Solvay
Pharmaceuticals and Shionogi/Nippon Kayaku. Benign prostate
hyperplasia is characterized by an abnormal, but not malignant,
testosterone-mediated growth of prostate tissue. BPH is estimated
to affect approximately 33 million men over 60 years of age. In
2004, the amount spent on drug treatment for this condition is
expected to be around US$1.8 billion. "We are very excited about
the positive results from this new Phase II trial, the last one
from a broad seven-study Phase II program evaluating cetrorelix in
a combination of indications, and believe it provides strong
evidence for the efficacy and safety of cetrorelix in BPH,
endometriosis and myoma," said Prof. Jurgen Engel, Executive Vice
President, Global R&D and Chief Operating Officer at AEterna
Zentaris. "These results, in our opinion, compare very favorably to
currently marketed therapies for BPH, which require daily
administration. We look forward to continued advancement of this
program by our development and marketing partners worldwide, and
the initiation of pivotal programs on cetrorelix, including in
BPH." "The successful completion of this latest trial is a
remarkable achievement and confirms the excellent partnership we
have built with AEterna Zentaris. We believe that the results of
the extensive Phase II program will now allow us to finalize the
development plans for the compound," stated Dr. Werner Cautreels,
Solvay Pharmaceuticals' Global Head of R&D. The randomized,
double-blind, placebo-controlled trial enrolled patients with
symptomatic and objectively defined BPH (decreased urine flow) and
was conducted in Europe, under the coordination of Professor Frans
MJ Debruyne from the Department of Urology, University Medical
Center in Nijmegen. All eligible patients received two
intramuscular injections of placebo, two weeks apart, during a
run-in period. After the initial four-week run-in period, 250
patients with symptomatic BPH were randomized into five equal
groups receiving either placebo injections or four different dosage
regimens from 60 to 120 mg in two or three injections of a depot
formulation of cetrorelix over the course of four weeks. Patients
were followed for up to 26 weeks after the last injection for
efficacy and safety assessments, as well as for levels of
testosterone and quality of life and sexual function. As early as
one month following the initiation of therapy, the use of
cetrorelix was associated with a dose- dependent, statistically
significant improvement of clinical signs and symptoms, including
IPSS and maximum uroflow, compared to placebo. Importantly, for all
dosage regimens the therapeutic response lasted until the last
observation point, i.e. 24 to 26 weeks following cessation of
cetrorelix administration. About AEterna Zentaris Inc. AEterna
Zentaris Inc. is a biopharmaceutical company focused in oncology
and endocrine therapy. Its extensive portfolio, from drug discovery
to marketed products, includes perifosine, an orally-active AKT
inhibitor in several Phase II trials for multiple cancers, and
cetrorelix, an LHRH antagonist already marketed for in vitro
fertilization under the brand name Cetrotide(R), and also in
advanced clinical development for the treatment of uterine myoma,
endometriosis and benign prostatic hyperplasia (BPH). AEterna
Zentaris also owns 62% of Atrium Biotechnologies Inc., which
develops, distributes and markets active ingredients, specialty
fine chemicals, cosmetic and nutritional products for the
cosmetics, chemical, pharmaceutical and nutritional industries.
News releases and additional information about AEterna Zentaris are
available on its new Web site 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. (FORMERLY/ANCIENNEMENT - LES LABORATOIRES AETERNA
CONTACT: Media Relations, Paul Burroughs, (418) 652-8525 ext. 406,
; Investor Relations, Jacques Raymond, (418) 652-8525 ext. 360, ;
U.S. Investor Relations, Lippert/Heilshorn & Associates, Kim
Golodetz, (212) 838-3777, ; Europe, Matthias Seeber, +49 69 42602
3425,
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