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 January 2005
AETERNA ZENTARIS INC.
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(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
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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 January 18, 2005 -AEterna Zentaris
Advances AN-152 Targeted Anti-Cancer Agent into Clinical
Development
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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 ADVANCES AN-152 TARGETED ANTI-CANCER
AGENT INTO CLINICAL DEVELOPMENT
QUEBEC CITY, CANADA, JANUARY 18, 2005 - AEterna Zentaris Inc. (TSX: AEZ; Nasdaq:
AEZS) today announced the initiation of a company-sponsored Phase I dose-ranging
study for its targeted anti-cancer agent AN-152, a novel cytotoxic conjugate
which has the potential to selectively and specifically target certain types of
cancer cells that express Luteinizing Hormone Releasing Hormones (LHRH)
receptors (LHRH receptor positive tumors) and thereby may offer a better safety
and efficacy profile as compared to the cytotoxic agent alone.
The Phase I study, which will be conducted at university clinics in Gottingen
and Frankfurt/Main in Germany, will evaluate the safety (including maximum
tolerated dose and dose-limiting toxicity) and pharmacokinetics of
intravenously-administered AN-152 in patients with LHRH receptor positive
ovarian, endometrial or breast cancer. A high percentage of these cancers, in
addition to hormone-refractory prostate cancer, are known to be LHRH receptor
positive and, therefore, represent logical initial indications for AN-152.
"The initiation of this study not only marks an important milestone in the
development of AN-152, a novel therapeutic approach against cancer, but also
provides yet another proof of the extremely successful collaboration between our
Company and the laboratory of Nobel Laureate Dr. Andrew Schally at Tulane
University in New Orleans", said Prof. Jurgen Engel, Executive Vice President,
Global R&D and COO of AEterna Zentaris.
AN-152 is a cytotoxic conjugate that is designed to achieve differential
delivery, or targeting, of the cytotoxic agent to cancer vs. normal cells. In
AN-152, doxorubicin (an FDA-approved cytotoxic agent) is chemically linked to an
LHRH agonist, a modified natural hormone with affinity for the LHRH receptor.
This design allows for the specific binding and selective uptake of the
cytotoxic conjugate by LHRH receptor positive tumors. Potential benefits of this
targeted approach are several-fold, and include a more favorable safety profile
with lower incidence and severity of side effects, as normal tissues are spared
from toxic effects of doxorubicin. Doxorubicin use is associated with
significant, frequently treatment-limiting cardiac toxicity. In addition, the
targeted approach may enable treatment of LHRH receptor positive cancers that
have become refractory to doxorubicin given in its non-targeted form.
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In preclinical studies conducted to date in several animal models of LHRH
receptor positive human cancer, AN-152`s anti-tumor activity and tolerability
were shown to be superior to that of doxorubicin. As would be expected, AN-152
was not active or was significantly less active than doxorubicin in LHRH
receptor negative cancer cell lines.
AEterna Zentaris has in-licensed worldwide rights to AN-152 from Tulane
University. AN-152 is the lead compound in a series of cytotoxic conjugates that
are designed to target certain tumor cells expressing receptors for peptide
hormones such as LHRH, bombesin and somatostatin.
ABOUT AETERNA ZENTARIS INC.
AEterna Zentaris Inc. is an oncology and endocrine therapy focused
biopharmaceutical company with proven expertise in drug discovery, development
and commercialization. The Company's broad, renewable product pipeline leverages
five 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),
and has successfully completed a broad Phase II program in endometriosis and
benign prostatic hyperplasia (BPH). The lead signal transduction inhibitor
compound, perifosine, is an orally-active AKT inhibitor that is in several Phase
II trials for multiple cancers.
AEterna Zentaris also owns 61.1% of Atrium Biotechnologies Inc., an
international company that develops, manufactures and markets added-value active
ingredients and specialty chemicals for the cosmetics, chemical, pharmaceutical
and nutritional industries, as well as health and nutrition products.
News releases and additional information about AEterna Zentaris are available on
its new 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 INVESTOR RELATIONS
Paul Burroughs Ginette Vallieres
(418) 652-8525 ext. 406 (418) 652-8525 ext. 265
paul.burroughs@aeternazentaris.com ginette.vallieres@aeternazentaris.com
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EUROPE
Dr. Mathias Pietras
+49-6942602-3423
mathias.pietras@zentaris.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: January 18, 2005 By: /s/Mario Paradis
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Mario Paradis
Senior Finance Director and Corporate Secretary