FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
REPORT OF FOREIGN ISSUER
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For the month of April 2008
Commission File No. 000-30752
AETERNA ZENTARIS INC.
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1405, boul. du Parc-Technologique
Quebec, Quebec
Canada, G1P 4P5
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports
under cover of Form 20-F or Form 40-F.
Form 20-F /X/ Form 40-F / /
Indicate by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934
Yes / / No /X/
If "Yes" is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b): 82-
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DOCUMENTS INDEX
DOCUMENTS DESCRIPTION
1. Press Release dated April 30, 2008: AEterna Zentaris: Lead Investigator for
Cetrorelix Trials in BPH Wins Best Poster Presentation Award at European
Association of Urology Meeting in Milan
AETERNA ZENTARIS
AETERNA ZENTARIS INC. 1405 du Parc-Technologique Blvd.
Quebec (Quebec) Canada G1P 4P5 T 418 652-8525 F 418 652-0881
www.aezsinc.com
PRESS RELEASE
For immediate release
AETERNA ZENTARIS: LEAD INVESTIGATOR FOR CETRORELIX TRIALS IN BPH WINS BEST
POSTER PRESENTATION AWARD AT EUROPEAN ASSOCIATION OF UROLOGY MEETING IN MILAN
QUEBEC CITY, CANADA, APRIL 30, 2008 - AEterna Zentaris Inc. (NASDAQ: AEZS, TSX:
AEZ), a global biopharmaceutical company focused on endocrine therapy and
oncology, today announced that Prof. Frans M.J. Debruyne, M.D., Ph.D., Chairman
and CEO of Andros Men's Health Institutes in The Netherlands, won the award for
Best Poster Presentation in a Poster Session at the 23rd Annual European
Association of Urology Meeting, which was held March 26-28, 2008 in Milan,
Italy. Titled "LHRH ANTAGONIST CETRORELIX FOR SYMPTOMATIC BPH: PROLONGED
IMPROVEMENT BEYOND END OF TREATMENT IN PLACEBO-CONTROLLED TRIALS." FMJ DEBRUYNE,
A.A. GRES, A. BANTSCHEV, M. TZVETKOV, K. GRDOVIC, the poster referred to
previously disclosed results from two Phase 2 trials with cetrorelix in benign
prostatic hyperplasia (BPH), which showed a prolonged duration of effect
extending far beyond the end of the short-term treatment course.
Prof. Jurgen Engel, Ph. D., Executive Vice President, Scientific Affairs at
AEterna Zentaris commented, "We would like to congratulate Professor Debruyne
for this prestigious award which acknowledges his significant contribution to
the quality and achievements of our drug development program with cetrorelix in
BPH. The data observed in these Phase 2 trials warranted our current extensive
Phase 3 program with cetrorelix in this same indication and we look forward to
presenting the results in Q3 2009, as stated previously. We believe cetrorelix
could provide a novel, efficient, convenient and safe treatment for the millions
of men with BPH."
THE POSTER
INTRODUCTION AND OBJECTIVES
Preliminary studies indicated prolonged, unmaintained improvement in signs and
symptoms of BPH after short courses of cetrorelix. Two placebo-controlled trials
investigated two formulations of cetrorelix to determine the extent and duration
of symptomatic improvement and to select the interval between courses for an
intermittent treatment scheme.
AETERNA ZENTARIS
TRIAL DESIGN
Trial-A compared 3 regimens of subcutaneous cetrorelix acetate with placebo (35
patients/group): 5mg x 4, 7 days apart; 10mg x 4, 7 days apart; and 10mg x 2, 14
days apart.
Trial-B compared 4 regimens of intramuscular cetrorelix pamoate with placebo (30
patients/group, 14 days between doses): 30mg x 2; 30mg x 3; 60mg and 30mg; 60mg
x 2. Patients were followed up for 20 and 28 weeks after the first dose in
Trial-A and B, respectively. International Prostate Symptom Score (I-PSS)
primary endpoint was assessed in 4-weekly intervals; other endpoints included
uroflow, prostate size, and testosterone levels.
RESULTS
In both trials, 4 weeks after first dose, all regimens showed a statistically
significant reduction in I-PSS from baseline; at week 12, the difference from
placebo was statistically significant for all dosage regimens except the 30mg x
2 in Trial-B (Trial-A: p< 0.05; Trial-B: p< 0.001). Generally, the improvement
in I-PSS, which tended to be better in the higher dosage groups of Trial-B
(reduction of 5-7 points, i.e. 30%-40%), was maintained throughout the follow-up
period and was paralleled by an improvement in uroflow. A slight, dose-dependent
reduction in prostate size was noticed in both trials. All dosage regimens
tested were well tolerated, and none were associated with sexual side effects.
CONCLUSIONS
In both studies, a prolonged duration of effect extending far beyond the end of
the short-term treatment course was observed. For the long-term management of
BPH patients, the results from both studies support a 6-month interval between
subsequent treatment courses.
ABOUT CETRORELIX
Cetrorelix is part of AEterna Zentaris' LHRH antagonist therapeutic approach
that has demonstrated in Phase 2 studies to provide fast and long-lasting relief
of BPH symptoms while being well tolerated, with a low incidence of sexual side
effects. Both BPH studies of cetrorelix presented in Milan were chaired by Prof.
Frans M.J. Debruyne, M.D., Ph.D., former President of EAU, now Chairman and CEO
of Andros Men's Health Institutes in The Netherlands.
Cetrorelix peptide-based drugs were developed by the Company in cooperation with
Nobel Prize winner Prof. Andrew Schally, currently of the U.S. Veterans
Administration in Miami.
Cetrorelix acetate is marketed under the brand name Cetrotide(R), the first LHRH
antagonist approved for therapeutic use as part of IN VITRO fertilization
programs (controlled ovarian stimulation/assisted reproductive technologies) in
Europe, the U.S. and Japan. It was launched on the market through Serono (now
Merck Serono) in the United States, Europe and in several other countries, as
well as in Japan through Shionogi.
AETERNA ZENTARIS
ABOUT THE CETRORELIX PHASE 3 PROGRAM IN BPH
Cetrorelix pamoate is being studied in three Phase 3 trials which will include
approximately 1,500 men with symptomatic BPH in the United States, Canada and
Europe. One Phase 3 efficacy trial, primarily in the United States and Canada
and with additional sites in Europe, involves approximately 600 patients (which
are fully enrolled) and is being led by Herbert Lepor, M.D., Professor and
Martin Spatz Chairman of Urology, New York University School of Medicine, New
York. In the trial, patients enter a no-treatment run-in observation period to
confirm severity and stability of voiding symptoms based on the International
Prostate Symptom Score (I-PSS). Patients are then randomly allocated to
cetrorelix or placebo in a double-blind fashion. Patients are administered
cetrorelix by intra-muscular (IM) injection at Week 0, 2, 26 and 28 and are
followed up to Week 52. Then, in an open-label extension, patients will receive
cetrorelix by IM injection at Week 52, 54, 78 and 80 will be followed up to Week
90.
A second, similarly designed multi-center Phase 3 efficacy study, being led by
Prof. Frans M.J. Debruyne, M.D., Ph.D., from The Netherlands, will enroll
approximately 400 patients in Europe. The third Phase 3 trial scheduled to start
shortly, is an open-label, single-armed multi-center safety study involving
approximately 500 patients in both North America and Europe, and is being led by
Joel Kaufman, M.D., Associate Clinical Professor of Urology, University of
Colorado School of Medicine, Denver, Colorado, and Urology Research Options,
Aurora, Colorado.
The primary endpoint for both North American and European efficacy studies is
the change in I-PSS between baseline and Week 52. Other efficacy endpoints
include additional measures of BPH-symptom progression and the need for
BPH-related surgery. Safety endpoints include changes in sexual function. Other
important endpoints include plasma changes in levels of testosterone, and
assessment of other adverse events.
The cetrorelix Phase 3 program is based on comprehensive clinical practice
guidelines to ensure quality control, including input from expert advisors on
study design, publishing results in peer-reviewed journals and discussion of the
studies with regulatory agencies.
BENIGN PROSTATIC HYPERPLASIA
Benign prostatic hyperplasia (BPH) is one of the most common diseases of aging
men - affecting more than 20 million men in the United States - but its etiology
is far from being completely understood. Data from ongoing research suggest BPH
and its associated lower urinary tract symptoms (LUTS) are more complex
conditions than once thought. While previous research on BPH etiology tended to
focus on testosterone and other hormones, more recent research suggests other
factors may play a greater role in the development of BPH and LUTS - including
inflammation, various growth factors, and adrenoreceptors.
BPH-associated LUTS include frequent urination and/or urgent need to urinate,
waking at night to urinate (nocturia), difficulty starting urination and/or weak
urinary stream, and feeling that the bladder is not completely empty after
urination. While current therapies provide some efficacy in BPH they are often
associated with troublesome sexual side effects.
AETERNA ZENTARIS
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 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 requested by a
governmental authority or applicable law.
CONTACTS
Dennis Turpin, CA
Senior Vice President and Chief Financial Officer
(908) 626-5503
dturpin@aezsinc.com
MEDIA RELATIONS
Paul Burroughs
Director of Communications
(418) 652-8525 ext. 406
pburroughs@aezsinc.com
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
AETERNA ZENTARIS INC.
Date: May 1, 2008 By: /s/Dennis Turpin
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Dennis Turpin
Senior Vice President, Chief Financial Officer