FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
REPORT OF FOREIGN ISSUER
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Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For the month of May 2005
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 Form 40-F X
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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
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Documents Description
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1. Press release dated May 11, 2005 - AEterna Zentaris' North American
Partner Announces Upcoming Data Presentation on Perifosine at the
American Society of Clinical Oncology Annual (ASCO) Meeting
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[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.aeternazentaris.com
PRESS RELEASE
For immediate release
AETERNA ZENTARIS' NORTH AMERICAN PARTNER ANNOUNCES
UPCOMING DATA PRESENTATION ON PERIFOSINE AT THE AMERICAN
SOCIETY OF CLINICAL ONCOLOGY ANNUAL (ASCO) MEETING
Initiation of new phase II trials in breast cancer as part of Keryx-sponsored
clinical program for perifosine
QUEBEC CITY, CANADA, MAY 11, 2005 - AEterna Zentaris Inc. (TSX: AEZ; NASDAQ:
AEZS) announces that its North American partner for perifosine, Keryx
Biopharmaceuticals, Inc. (Nasdaq: KERX) announced earlier today that the results
of a Phase II trial for patients with early prostate cancer will be presented at
the annual meeting of the American Society of Clinical Oncology (ASCO) in
Orlando. The presentation entitled "The AKT Inhibitor Perifosine in
Biochemically Recurrent Prostate Cancer (HSPC): A Phase 2 California Consortium
Trial" is scheduled for Saturday, May 14, 2005 from 8:00am to 12:00pm EDT, in
Hall C, level 2 of the Conference Center. Perifosine is a novel, oral,
first-in-class anticancer agent that appears to work by modulating a number of
signal transduction pathways, including AKT.
Our North American partner, Keryx, also announced that the following combination
clinical studies have now been initiated as part of its corporate-sponsored
clinical program for perifosine:
o Phase II combination study of perifosine and Trastuzumab (Herceptin(R)), an
approved human monoclonal antibody for the treatment of metastatic breast
cancer. This multi-center Phase II trial will evaluate perifosine in
combination with Herceptin(R) in breast cancer patients whose tumors
overexpress HER2/neu and who have failed previous treatments with
Herceptin(R) or Herceptin(R) plus chemotherapy.
o Phase II study of perifosine in combination with endocrine therapy for
patients with estrogen receptor or progesterone receptor positive
metastatic breast cancer.
Other studies that have been initiated pursuant to the Keryx-sponsored clinical
program with perifosine include:
o A single-agent Phase I/II trial of perifosine in the treatment of non-small
cell lung cancer;
[AEterna Zentaris Logo]
o A Phase I trial of the combination of perifosine and paclitaxel;
o A phase I trial of the combination of perifosine and docetaxel;
o A phase I trial of the combination of perifosine and gemcitabine;
o A single-agent Phase II trial of perifosine in patients with various tumors
for which no standard therapy exists either because the tumors have become
unresponsive to standard treatments or no effective form of systemic
therapy has been established.
In addition to this Keryx-sponsored clinical program for perifosine, Keryx has
ongoing clinical and preclinical collaborations with several prestigious medical
institutions and universities, including Memorial Sloan-Kettering, MD Anderson,
Dana Farber, UCSF, Emory, the National Cancer Institute and the Netherlands
Cancer Institute.
Perifosine is out-licensed by AEterna Zentaris to Keryx, which holds North
American rights to the drug. AEterna Zentaris holds the rest of the world
rights.
Herceptin(R) is a trademark of Genentech, Inc.
ABOUT PERIFOSINE
Perifosine, a novel, first-in-class, oral anticancer agent that modulates
several key signal transduction pathways, including AKT, MAPK, and JNK that have
been shown to be critical for the survival of cancer cells. Perifosine has
demonstrated single agent anti-tumor activity in Phase I and Phase II studies
and is currently being studied as a single agent and in combination with several
forms of anti-cancer treatments for various forms of cancer, including non-small
cell lung cancer and breast cancer.
ABOUT AETERNA ZENTARIS INC.
AEterna Zentaris Inc. is an oncology and endocrine therapy focused
biopharmaceutical company with proven expertise in drug discovery, development
and marketing. The Company's broad 20 product pipeline leverages six different
therapeutic approaches, including LHRH antagonists and signal transduction
inhibitors. The lead LHRH antagonist compound, cetrorelix, is currently marketed
for IN VITRO fertilization under the brand name Cetrotide(R). Cetrorelix is also
in late-stage clinical development for endometriosis and benign prostatic
hyperplasia (BPH). The lead signal transduction inhibitor compound, perifosine,
is a novel, first-in-class, oral anticancer agent that modulates several key
signal transduction pathways, including AKT, MAPK, and JNK that have been shown
to be critical for the survival of cancer cells. Perifosine has demonstrated
single agent anti-tumor activity in Phase I and Phase II studies and is
currently being studied as a single agent and in combination with several forms
of anti-cancer treatments for various forms of cancer, including non-small cell
lung cancer and breast cancer.
AEterna Zentaris also owns 50.3% of Atrium Biotechnologies Inc. (TSX: ATB.sv), a
leading developer, manufacturer and marketer of value-added products for the
cosmetics, pharmaceutical, chemical and nutritional industries.
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[AEterna Zentaris Logo]
News releases and additional information about AEterna Zentaris are available on
its Web site www.aeternazentaris.com.
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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
Paul Burroughs
(418) 652-8525 ext. 406
paul.burroughs@aeternazentaris.com
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INVESTOR RELATIONS
Ginette Vallieres
(418) 652-8525 ext. 265
ginette.vallieres@aeternazentaris.com
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EUROPE
Matthias Seeber
+49 69 42602 3425
matthias.seeber@aeternazentaris.com
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SIGNATURE
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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 11, 2005 By: /s/Mario Paradis
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Mario Paradis
Senior Finance Director and Corporate Secretary