AEterna Zentaris Announces Positive Phase 2 Results for Ozarelix (D-63153) in Hormone-Dependent Inoperable Prostate Cancer
August 02 2006 - 8:00AM
PR Newswire (US)
Company to further advance the clinical development of ozarelix in
this indication QUEBEC CITY, Aug. 2 /PRNewswire-FirstCall/ --
AEterna Zentaris Inc. (TSX: AEZ; NASDAQ: AEZS) today disclosed
positive headline data from its Phase 2 trial with ozarelix for
patients suffering from hormone-dependent inoperable prostate
cancer. This open-label, randomized-controlled Phase 2 dose-finding
trial originally designed for 48 patients was extended to 64
patients where 4 groups of 16 patients received different
intramuscular dosage regimens of the luteinizing hormone releasing
hormone (LHRH) antagonist, ozarelix, to assess its safety and
efficacy. The study achieved its primary end-point of defining a
tolerable dosage regimen of ozarelix that would ensure continuous
suppression of testosterone at castration level (< 0.5 ng/ml)
for a three-month test period. An important secondary efficacy
end-point of the study aimed at assessing tumour response as
determined by a 50% or greater reduction of serum PSA levels,
compared to baseline, was also achieved. The trial was conducted in
Europe in collaboration with AEterna Zentaris' partner Spectrum
Pharmaceuticals Inc. (NASDAQ:SPPI). In this study, ozarelix IM 65
mg, 100 mg or 130 mg was administered according to different dosing
schedules and repeated for 3 cycles of 28 days. The total dose by
patient during the study ranged from 230 mg to 390 mg. The best
results regarding the primary end-point of continuous suppression
of testosterone were obtained at the upper limit of that range and
especially with a dose of 130 mg per cycle where all patients
remained suppressed to castration until at least day 85.
Furthermore, in patients with continuous testosterone suppression
below castration level, tumour response as measured by PSA levels
was 97%. Ozarelix was well tolerated at all dosages. The detailed
results from the study will be presented at the upcoming SIU
(Societe internationale d'urologie) meeting in Cape Town, South
Africa, on November 12, 2006. The Company has initiated, in
collaboration with its partner Spectrum Pharmaceuticals, an
additional study which will enroll 32 patients at other European
clinical sites to verify and optimize the findings derived from the
cohort of patients having received 130 mg of ozarelix per cycle.
"We are very excited with these results which confirm the mechanism
of action of our LHRH antagonist approach and the potential
effectiveness of ozarelix to achieve sustained suppression of
sexual hormones at castration levels and, consequently, could allow
for the treatment of hormone-dependent cancers. Now that we have a
suitable dosage regimen of ozarelix for the potential treatment of
prostate cancer, we are pleased to further advance the clinical
development of ozarelix in this indication with a Phase 2b
program," commented Dr. Jurgen Engel, Executive Vice President,
Global R&D and Chief Operating Officer at AEterna Zentaris.
"These positive results further validate the potential of our LHRH
antagonist approach and strengthen ozarelix's position as a lead
compound in our portfolio," stated Gilles Gagnon, President and
Chief Executive Officer at AEterna Zentaris. "We are now in an even
better position to execute our strategy in building a strong
oncology franchise." About Ozarelix (D-63153) and Development
Alliance with Spectrum Pharmaceuticals Ozarelix (D-63153) is a
fourth generation luteinizing hormone releasing hormone (LHRH)
antagonist administered as a depot formulation for the treatment of
hormone-dependent prostate cancer. In August 2004, AEterna Zentaris
granted Spectrum Pharmaceuticals an exclusive license to develop
and market ozarelix (D-63153) for all potential indications in
North America and India while AEterna Zentaris retains exclusive
rights to the rest of the world. About Prostate Cancer According to
Decision Resource, 395,000 new cases of prostate cancer were
diagnosed in 2005 in the 7 major markets around the world.
Treatment costs in these markets for this indication in 2005 were
estimated at some US$3.3 billion. About AEterna Zentaris Inc.
AEterna Zentaris Inc. is a growing global biopharmaceutical company
focused on oncology and endocrine therapy with proven expertise in
drug discovery, development and commercialization. AEterna Zentaris
also owns 48.26% of the equity of Atrium Biotechnologies Inc. (TSX:
ATB) and 64.69% of its voting rights. Atrium is a developer,
manufacturer and marketer of science-based products for the
cosmetics, pharmaceutical, chemical and nutritional industries.
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. (FORMERLY/ANCIENNEMENT - LES LABORATOIRES AETERNA
LABORATORIES INC.) CONTACT: Media Relations: Paul Burroughs, (418)
652-8525 ext. 406, ; Investor Relations: Jenene Thomas, (418)
655-6420 or (908) 996-3154,
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