AEterna Zentaris Announces Initiation of a European Multi-Center Phase II Trial of D-63153 in Benign Prostate Hyperplasia
April 13 2005 - 9:16AM
PR Newswire (US)
AEterna Zentaris Announces Initiation of a European Multi-Center
Phase II Trial of D-63153 in Benign Prostate Hyperplasia QUEBEC
CITY, Canada, April 13 /PRNewswire-FirstCall/ -- AEterna Zentaris
Inc. (TSX: AEZ; Nasdaq: AEZS) today announced the initiation of a
European multi- center, placebo-controlled Phase II trial to
evaluate the efficacy, as well as the safety and tolerability of
D-63153, a fourth generation LHRH (Luteinizing Hormone Releasing
Hormone) antagonist, in patients with benign prostate hyperplasia
(BPH). The double-blind placebo-controlled Phase II trial will
evaluate the efficacy of D-63153 as measured by its effects on
clinical signs and symptoms characteristic of BPH, including the
International Prostate Symptom Score (IPSS) and maximum uroflow, as
well as the durability of therapeutic response over several months.
This trial will be fully funded by Spectrum Pharmaceuticals, Inc.
(NASDAQ:SPPI), AEterna Zentaris' U.S. development partner for
D-63153. "We are very pleased to see the timely initiation of this
second Phase II trial of D-63153 now in benign prostate hyperplasia
(BPH), on the heels of the Phase II trial initiation of
hormone-dependent prostate cancer Phase II study announced earlier
this week," said Prof. Jurgen Engel, Executive Vice President,
Global R&D and COO of AEterna Zentaris. He added: "Furthermore,
we believe that D-63153 which allows for chronic intermittent
treatment has the potential to improve clinical symptoms of BPH
while overcoming some of the limitations associated with currently
marketed therapies, including the need for daily administration and
side effects such as erectile dysfunction and loss of libido."
Gilles Gagnon, President and Chief Executive Officer of AEterna
Zentaris added: "Today's announcement completes the full deployment
of our strategy with our LHRH-antagonist therapeutic approach. With
this multi-product strategy combined with our multi-partner
approach, we are now in a position to further advance on a
worldwide basis the clinical development of all of our
LHRH-antagonist compounds in commercially attractive indications
such as endometriosis, BPH and prostate cancer. About Benign
Prostate Hyperplasia (BPH) 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. This
year, the amount spent on drug treatment for this condition is
expected to be around US$1.8 billion. About D-63153 strategic
alliance with Spectrum Pharmaceuticals In August 2004, AEterna
Zentaris granted to Spectrum Pharmaceuticals an exclusive license
to develop and market D-63153 for all potential indications in
North America (including Canada and Mexico) and India. AEterna
Zentaris received an upfront payment which included cash and equity
of Spectrum, at signature, and is eligible to receive payments upon
achievement of certain development and regulatory milestones, in
addition to royalties on potential net sales. AEterna Zentaris
retains exclusive rights to the rest of world and will share with
Spectrum upfront and milestone payments, royalties or profits from
potential sales in Japan. About AEterna Zentaris Inc. AEterna
Zentaris Inc. is an oncology and endocrine therapy focused
biopharmaceutical company with proven expertise in drug discovery,
development and commercialization. The Company's broad 20 product
pipeline leverages five different therapeutic approaches, including
LHRH antagonists and signal transduction inhibitors. The lead LHRH
antagonist compound, cetrorelix, is currently marketed for in vitro
fertilization under the brand name Cetrotide(R). Cetrorelix is also
in late-stage clinical development for endometriosis and benign
prostatic hyperplasia (BPH). The lead signal transduction inhibitor
compound, perifosine, is an orally-active AKT inhibitor that is in
several Phase II trials for multiple cancers. AEterna Zentaris also
owns 50.7% of Atrium Biotechnologies Inc. (TSX: ATB.sv), a leading
developer, manufacturer and marketer of value-added products for
the cosmetics, pharmaceutical, chemical and nutritional industries.
News releases and additional information about AEterna Zentaris are
available on its 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, Ginette Vallieres, (418) 652-8525 ext. 265, ;
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