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 December 2008
AETERNA ZENTARIS INC.
----------------------------------
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-____
DOCUMENTS INDEX
---------------
DOCUMENTS DESCRIPTION
------------------------------------------------------------------------------
1. Press Release dated December 11, 2008: AEterna Zentaris Completes Patient
Recruitment for Safety Trial of Phase 3 Program with Cetrorelix in
Benign Prostatic Hyperplasia
-------------------------------------------------------------------------------
[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 COMPLETES PATIENT RECRUITMENT FOR SAFETY TRIAL OF PHASE 3
PROGRAM WITH CETRORELIX IN BENIGN PROSTATIC HYPERPLASIA
QUEBEC CITY, CANADA, DECEMBER 11, 2008 - AEterna Zentaris Inc. (NASDAQ: AEZS;
TSX: AEZ), a global biopharmaceutical company focused on endocrine therapy and
oncology, today reported it has reached its goal of recruiting 500 patients for
the safety study of the Phase 3 program in benign prostatic hyperplasia (BPH)
with its flagship product candidate, cetrorelix, a novel investigational
luteinizing hormone-releasing hormone (LHRH) antagonist. This safety trial, the
third of three Phase 3 studies - involving a total of over 1,500 patients will
define the role of cetrorelix in the treatment of BPH, a non-cancerous
enlargement of the prostate affecting millions of men.
"With today's announcement, all three trials of our Phase 3 program in BPH with
cetrorelix are now fully recruited according to our scheduled timelines. We now
look forward to the disclosure of the first efficacy results in the third
quarter of 2009 which could be followed by an NDA in 2010," said Paul Blake,
M.D., Senior Vice President and Chief Medical Officer at AEterna Zentaris.
"Furthermore, this milestone brings us one step closer to our goal of providing
a novel, safe and efficient therapeutic approach to the millions of men
suffering from BPH."
The safety study titled, "CETRORELIX PAMOATE IN PATIENTS WITH SYMPTOMATIC BPH:
AN OPEN-LABELED SAFETY AND EFFICACY ASSESSMENT STUDY", being
conducted in North America, will assess an intermittent dosage regimen of
cetrorelix pamoate as a potential safe and tolerable treatment providing
prolonged improvement in BPH-related signs and symptoms. Patients receive
cetrorelix pamoate by intra-muscular (IM) injection at Weeks 0 and 2, and are
followed up to Week 26. The main endpoint is the incidence of possibly
drug-related adverse events.
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 CityplaceMiami.
[AETERNA ZENTARIS LOGO]
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 include over
1,500 men with symptomatic BPH in the United States, Canada and Europe. The
first Phase 3 efficacy trial conducted primarily in the United States and Canada
and with additional sites in Europe, involves approximately 600 patients
(completion of patient recruitment announced on April 15, 2008) 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 and will be followed up to Week 90.
A second, similarly designed ongoing multi-center Phase 3 efficacy study
(completion of patient recruitment announced on October 1, 2008), led by Prof.
Frans M.J. Debruyne, M.D., Ph.D., from The Netherlands, involves approximately
400 patients, mainly in Europe.
The third Phase 3 trial (completion of patient recruitment was announced today)
is an open-label, single-armed multi-center safety study involving approximately
500 patients in North America, 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.
2
[AETERNA ZENTARIS LOGO]
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.
INVESTOR RELATIONS MEDIA RELATIONS
Ginette Vallieres Paul Burroughs
Investor Relations Coordinator Director of Communications
(418) 652-8525 ext. 265 (418) 652-8525 ext. 406
gvallieres@aezsinc.com pburroughs@aezsinc.com
-30-
3
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: DEC. 10, 2008 By: /S/ DENNIS TURPIN
-------------------------------------
Dennis Turpin
Senior Vice President and Chief
Financial Officer