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 May 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 May 13, 2008: AEterna Zentaris: Article on Phase 2
Trial with Cetrorelix in BPH to be Published in European Urology Journal
[AETERNA ZENTARIS LOGO]
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: ARTICLE ON PHASE 2 TRIAL WITH CETRORELIX IN BPH TO BE
PUBLISHED IN EUROPEAN UROLOGY JOURNAL
QUEBEC CITY, CANADA, MAY 13, 2008 - AEterna Zentaris Inc. (NASDAQ: AEZS, TSX:
AEZ), a global biopharmaceutical company focused on endocrine therapy and
oncology, today announced that the article titled "PLACEBO-CONTROLLED
DOSE-RANGING PHASE 2 STUDY OF SUBCUTANEOUSLY ADMINISTERED LHRH ANTAGONIST
CETRORELIX IN PATIENTS WITH SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH", has
been accepted for publication in an upcoming issue of the European Urology
Journal. Written by F.M.J. Debruyne, Department of Urology, Academic Hospital
Nijmegen, The Netherlands, A.A. Gres, Clinical Urology MOKB, Minsk, Belarus, and
D.L. Arustamov, Center of Urology, Ministry of Health of Republic of Uzbekistan,
the article refers to results of a Phase 2 trial with cetrorelix in BPH, which
showed a prolonged improvement in BPH symptoms and uroflow, persisting up to the
end of the 20-week observation period.
These results are part of previously disclosed Phase 2 data on cetrorelix in BPH
through prior abstracts and poster presentations. The article is available
online at WWW.EUROPEANUROLOGY.COM
Prof. Jurgen Engel, Ph.D., Executive Vice President, Scientific Affairs at
AEterna Zentaris commented, "We are very proud to have the work of Prof.
Debruyne and his colleagues on cetrorelix published in this prestigious peer
reviewed European journal. The article, along with the recent Best Poster
Presentation Award that Prof. Debruyne received last March at the 23rd Annual
European Association of Urology Meeting, is another acknowledgement of the
quality of our development program with cetrorelix in BPH."
THE ABSTRACT
BACKGROUND AND OBJECTIVES
Pilot studies with daily dosing suggested the use of the luteinizing
hormone-releasing hormone antagonist cetrorelix for the treatment of symptoms
from BPH. The objective was to assess efficacy and safety of three dosing
schemes of cetrorelix in patients with symptomatic BPH.
TRIAL DESIGN
After a run-in period with four weekly injections of placebo, 140 patients with
an international prostate symptoms score (I-PSS) =13 and a peak urinary flow
rate (PFR) 5-13 ml/s were randomly allocated to four treatment groups. Patients
received either cetrorelix at dosages of 5 mg/wk x 4, 10 mg/wk x 2 or 10 mg/wk x
4 or placebo.
Main and secondary endpoints included I-PSS, PFR and mean uroflow, residual
urinary volume, prostate volume, plasma testosterone, quality of life, and
sexual function which were evaluated over a total of 20 weeks after
randomization.
RESULTS
In all cetrorelix groups, a rapid improvement in mean I-PSS was obtained, with a
peak effect of -5.4 to -5.9 (placebo: -2.8). After all dosages of cetrorelix
given, changes from baseline and differences to placebo were statistically
significant up to week 20. Similarly, secondary parameters showed a significant,
rapid, and persistent improvement for all cetrorelix dosages. All dosage
regimens were well tolerated. The study evaluated a single treatment course
only; further studies with repeated treatment courses will be required to
establish a dose regimen for long-term disease management.
CONCLUSIONS
In summary, the trial showed a rapid onset in improvement of I-PSS, urinary
symptoms and quality of life, accompanied by a slight reduction in prostate size
with a short course therapy with cetrorelix. The improvement lasted well beyond
the dosing period. This should, therefore, allow for the development of
intermittent dosage regimens of cetrorelix with two or three treatment courses
per year, thus relieving concerns about treatment compliance with drugs
requiring daily dosing.
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. 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.
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 ongoing 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 currently
screening patients, 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.
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 14, 2008 By: /S/DENNIS TURPIN
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Dennis Turpin
Senior Vice President, Chief Financial Officer