AEterna Zentaris Announces Results from its European Phase 3 Study with Cetrorelix in Benign Prostatic Hyperplasia
07 Dicembre 2009 - 1:40PM
PR Newswire (US)
QUEBEC CITY, Dec. 7 /PRNewswire-FirstCall/ -- AEterna Zentaris Inc.
(NASDAQ: AEZS; TSX: AEZ) (the "Company"), a global
biopharmaceutical company focused on endocrine therapy and
oncology, today reported Phase 3 results for its European efficacy
trial Z-036 in benign prostatic hyperplasia (BPH), with cetrorelix
pamoate. Study Z-036 did not reach its primary endpoint. There were
no clear differences in overall efficacy, with all 3 groups
(including placebo) showing an improvement in International
Prostate Symptom Score (IPSS) of approximately 6 points that was
maintained throughout the 52 weeks. There was observation of an
improvement in uroflow, both maximum and mean, and in residual
volume in all treatment groups. These favorable changes are
reflected in an overall improvement in Quality of Life measures.
Cetrorelix was well tolerated, there were no relevant differences
to placebo with regard to both clinical adverse events or changes
in laboratory parameters with the exception of the anticipated
hormonal changes. Juergen Engel, Ph.D., AEterna Zentaris President
and CEO stated, "We are obviously disappointed by the failure of
study Z-036 to reach its efficacy endpoint. Despite the
disappointment, we would like to thank the investigators and all
those involved in this project for their dedicated work. We will
now focus our development efforts on our late-stage oncology
compounds perifosine, our oral PI3K/AKT inhibitor and AEZS-108, our
targeted doxorubicin conjugate, as well as our oral ghrelin agonist
AEZS-130 in endocrinology." About study Z-036 The multi-center
efficacy trial Z-036 was conducted in 39 sites in 10 European
countries, under the supervision of lead investigator, Prof. Frans
MJ Debruyne, M.D., Director of the Andros Mannenkliniek in Arnhem,
The Netherlands. Patients entered a 1- to 4-week screening period
to confirm severity and stability of voiding symptoms based on the
IPSS. Patients were then randomly allocated in a double-blind
fashion to one of two cetrorelix dose groups or placebo, in a 2:1:1
ratio. Patients were administered cetrorelix by intra-muscular (IM)
injection at Week 0, 2, 26 and 28 (for treatment Arm A, those in
Arm B received IM injection at week 0, 2 and placebo injections
both at Week 26 and 28). Patients in treatment Arm C received
placebo injections at Week 0, 2, 26 and 28. All patients were
followed up to Week 52. The study included 420 patients overall,
212, 106, and 102 patients allocated to Arm A, B, and C,
respectively. Conference Call The Company will host a conference
call and webcast to discuss these results later today, Monday,
December 7, 2009 at 4:30 p.m., Eastern Time. Participants may
access the live webcast via the Company's website at
http://www.aezsinc.com/ in the "Investors" section, or by telephone
using the following numbers: (outside Canada): 888-231-8191,
(Canada): 514-807-9895 or 647-427-7450. A replay of the webcast
will also be available on the Company's website for a period of 30
days. About the Phase 3 Program with Cetrorelix in BPH The Phase 3
trial program involving more than 1,600 patients with symptomatic
BPH in Canada, the United States and Europe has been completed. In
addition to the efficacy trial Z-036, the program included a
placebo-controlled safety and efficacy trial Z-033, the
single-armed safety study Z-041, and the Thorough QT study Z-043.
Results for all of these trials were disclosed recently. About
Cetrorelix Cetrorelix pamoate is a compound that was being
investigated for the treatment of BPH. Cetrorelix is part of
AEterna Zentaris' luteinizing hormone-releasing hormone (LHRH)
antagonist therapeutic approach. 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 required by a governmental authority or applicable law.
DATASOURCE: AETERNA ZENTARIS INC. CONTACT: Investor Relations:
Dennis Turpin, SVP and CFO, (418) 652-8525 ext. 242, ; Media
Relations: Paul Burroughs, Director of Communications, (418)
652-8525 ext. 406,
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