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 September 2004
AETERNA ZENTARIS INC.
(Formerly named AEterna Laboratories 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 Form 40-F X
------ ------
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
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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
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1. Press release dated September 30, 2004 - Data from Perifosine Phase II
Single-Agent Soft Tissue Sarcoma Study Presented at the 16th Annual
EORTC-NCI-AACR Conference
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AEterna Zentaris
AEterna Zentaris Inc. 1405 du Parc-Technologique Blvd.
Quebec (Quebec) Canada G1P 4P5 T 418 652-8525 F 418 577-7697
www.aeternazentaris.com
PRESS RELEASE
For immediate release
DATA FROM PERIFOSINE PHASE II SINGLE-AGENT SOFT TISSUE SARCOMA STUDY PRESENTED
AT THE 16TH ANNUAL EORTC-NCI-AACR CONFERENCE
QUEBEC CITY, CANADA, SEPTEMBER 30, 2004 - AEterna Zentaris Inc. (TSX: AEZ;
NASDAQ: AEZS) through its North American partner, Keryx Biopharmaceuticals, Inc.
(Nasdaq: KERX), announced today that Phase II data presented at the 16th Annual
EORTC-NCI-AACR symposium on "Molecular Targets and Cancer Therapeutics"
demonstrated the tolerability and potential efficacy of perifosine in the
treatment of patients with advanced soft tissue sarcoma. This study was
conducted by the National Cancer Institute (NCI) pursuant to a Collaborative
Research and Development Agreement (CRADA) between Keryx and the NCI.
In this single-agent Phase II multi-center study of perifosine, 23 patients with
advanced soft-tissue sarcoma received a loading dose of 150 mg, every six hours
starting on day one, followed by 100 mg daily thereafter. The patients enrolled
in this study had prior treatment, including 1-2 chemotherapy regimens, surgery
and/or radiotherapy. Nineteen patients received more than one course of
treatment. There was one confirmed partial response lasting more than five
months and two patients that remained progression-free at six months.
Perifosine was also shown to be well tolerated at the doses used. All 23
patients were evaluable for toxicity and notable toxicities seen included Grade
4 ileus (one patient), Grade 3 toxicity (six patients) including fatigue (two
patients) and one patient each of anemia, infection, muscle weakness, pain,
rash, anorexia, dehydration, and diarrhea. Of the Grade 3 and 4 toxicities seen,
it is unclear which ones were related to the disease or the drug. There was no
Grade 3 or 4 nausea or vomiting seen in this trial.
The authors concluded in summary that the regimen was tolerable and that the
preliminary observation of another responder in soft tissue sarcoma, such as was
seen in the Phase I program, raises the question of whether specific histologies
or tumor characteristics might predict a more sensitive subpopulation of soft
tissue sarcoma patients.
I. Craig Henderson, M.D., President of Keryx Biopharmaceuticals, commented, "The
level of activity seen in this study, combined with the previous Phase I
single-agent experience where two partial responses were reported out of ten
sarcoma patients enrolled, provides us with very strong evidence for the
potential single-agent activity of this drug in soft tissue sarcoma,
AEterna Zentaris
particularly in one or more subtypes." Dr. Henderson added, "Soft tissue sarcoma
is a very aggressive disease characterized by many heterogeneous subtypes or
histologies, for which few, if any, drugs work across multiple subtypes. The
overall response rate of sarcomas to the most effective front-line chemotherapy
treatments is about 10-20%, and some subtypes are totally unresponsive to any
form of chemotherapy."
Dr. Henderson also stated, "We believe that our correlative science program will
help us to potentially identify at least one subtype of soft tissue sarcoma for
which we may be able to conduct a single-agent registration trial with
perifosine in the near future."
Gilles Gagnon, Chief Executive Officer and President of AEterna Zentaris,
concluded, "We are pleased with the continued advancement of clinical
development of perifosine by our partner Keryx and their ongoing commitment to
aggressively develop perifosine as a single agent or in combination with other
cancer treatments."
To access the abstract, entitled "Tolerability and limited activity of
perifosine in patients with advanced soft tissue sarcoma (STS): a multi-center
phase 2 consortium (P2C) study," please click here.
Perifosine is in-licensed by Keryx fromAEterna Zentaris Inc. (TSX: AEZ, Nasdaq:
AEZS), which holds ex-North American rights to the drug.
ABOUT AETERNA ZENTARIS INC.
AEterna Zentaris Inc. is a biopharmaceutical company focused in oncology and
endocrine therapy. Its extensive portfolio, from drug discovery to marketed
products, includes perifosine, an orally-active AKT inhibitor in several Phase
II trials for multiple cancers, and cetrorelix, an LHRH antagonist already
marketed for IN VITRO fertilization under the brand name Cetrotide(R), and also
in advanced clinical development for the treatment of uterine myoma,
endometriosis and benign prostatic hyperplasia (BPH).
AEterna Zentaris also owns 62% of Atrium Biotechnologies Inc., which develops,
distributes and markets active ingredients, specialty fine chemicals, cosmetic
and nutritional products for the cosmetics, chemical, pharmaceutical and
nutritional industries.
News releases and additional information about AEterna Zentaris are available on
its new Web site 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.
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CONTACTS:
MEDIA RELATIONS INVESTOR RELATIONS
Paul Burroughs Jacques Raymond
(418) 652-8525 ext. 406 (418) 652-8525 ext. 360
paul.burroughs@aeternazentaris.com jacques.raymond@aeternazentaris.com
U.S. INVESTOR RELATIONS EUROPE
Lippert/Heilshorn & Associates Matthias Seeber
Kim Golodetz +49 69 42602 3425
(212) 838-3777 matthias.seeber@zentaris.de
kgolodetz@lhai.com
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: SEPTEMBER 30, 2004 By: /s/ MARIO PARADIS
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Mario Paradis
Senior Finance Director and
Corporate Secretary