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-
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DOCUMENTS INDEX
DOCUMENTS DESCRIPTION
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1. Press release dated May 16, 2005 - AEterna Zentaris' North
American Partner Announces Disclosure of Phase II results with
Perifosine in prostate cancer at the American Society of
Clinical Oncology Annual (ASCO) Meeting
[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 DISCLOSURE OF PHASE II
RESULTS WITH PERIFOSINE IN PROSTATE CANCER AT THE AMERICAN SOCIETY OF CLINICAL
ONCOLOGY ANNUAL (ASCO) MEETING
FURTHER EVIDENCE OF SINGLE AGENT ACTIVITY OBSERVED
QUEBEC CITY, CANADA, MAY 16, 2005 - AEterna Zentaris Inc. (TSX: AEZ; NASDAQ:
AEZS) announced that its North American partner for perifosine, Keryx
Biopharmaceuticals, Inc. (Nasdaq: KERX) disclosed earlier today that data
presented at the annual meeting of the American Society of Clinical Oncology
(ASCO) in Orlando, Florida, demonstrated the tolerability and potential efficacy
of perifosine in the treatment of patients with biochemically recurrent
hormone-sensitive prostate cancer (HSPC). This study was conducted by a
consortium of cancer centers under the leadership of the University of
California, Davis pursuant to a Collaborative Research and Development Agreement
(CRADA) between Keryx and the National Cancer Institute. Perifosine is a novel,
oral, anticancer agent that modulates AKT and several other important signal
transduction pathways, including MAP kinase and JNK.
This single-agent Phase II multi-center study of perifosine enrolled 25 patients
with HSPC who had received prior prostatectomy and/or radiation treatment and
had a rising PSA without radiographic metastasis. In the study, the patients
received a loading dose of perifosine of 900mg on day one, in divided doses of
at least six hours apart, then 100mg daily. Of the 25 patients enrolled, 22 were
evaluable for response. Of the evaluable patients, 18 patients (82%) had stable
disease and 3 (14%) had PSA progression. While no patients had a >50% reduction
in PSA, 3 patients (14%) had a minor response demonstrated by a PSA reduction of
less than 50%. Grade 3-4 toxicities included grade 3 hyponatremia, arthritis,
hyperuricemia and vision change.
The authors concluded that perifosine in HSPC patients is feasible,
well-tolerated and can reduce PSA by less than 50% in some patients. Because
of its inhibitory effects on the P13K/AKT pathway, further studies of
perifosine in combination with androgen ablation and chemotherapy are
warranted.
[AETERNA ZENTARIS LOGO]
Michael S. Weiss, Chairman and Chief Executive Officer of Keryx, stated, "We are
very pleased with the results of this study. These data provide additional
evidence of perifosine's potential anti-cancer activity and provide a strong
basis for further studies in prostate cancer, which we plan to initiate this
year. Our goal remains to provide data from our corporate sponsored clinical
program later this year or early next year that will lead us to one or more
regulatory approval pathways."
"We are appreciative of Keryx's strong commitment to pursue further clinical
trials with perifosine following these encouraging data. Later this year, we
will initiate our own Phase II clinical trials of perifosine in combination with
radiotherapy, as part of our comprehensive development program for this
product," said Prof. Jurgen Engel, Executive Vice President, Global R&D and
Chief Operating Officer at AEterna Zentaris.
To access the abstract, entitled "The AKT Inhibitor Perifosine in Biochemically
Recurrent Prostate Cancer (HSPC): A Phase 2 California Cancer Consortium Trial"
please click on www.keryx.com/pr/0401abstract.pdf.
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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.
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
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 17, 2005 By: /s/ Mario Paradis
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Mario Paradis
Senior Finance Director and
Corporate Secretary