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 February 2006
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 ________ 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
-------
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 February 17, 2006: AEterna Zentaris : Update on
U.S. NCI Sponsored Phase III Trial with Neovastat in Non-Small Cell
Lung Cancer
-------------------------------------------------------------------------------
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: UPDATE ON U.S. NCI SPONSORED PHASE III TRIAL WITH NEOVASTAT
IN NON-SMALL CELL LUNG CANCER
QUEBEC CITY, CANADA, FEBRUARY 17, 2006 - AEterna Zentaris Inc. (TSX: AEZ;
Nasdaq: AEZS) today announced that following a Data and Safety Monitoring Board
recommendation, based solely on a slow patient recruitment rate, the United
States National Cancer Institute (NCI) has decided to interrupt patient
recruitment for the ongoing Phase III trial in non-small cell lung cancer
(NSCLC) with Neovastat, while awaiting for an interim efficacy data analysis
planned at 320 events. Meanwhile, this NCI sponsored trial continues as planned
and patients will be maintained on the current therapy regime.
"We agree with the NCI's decision given the fact that we have reached a
sufficient number of enrolled patients enabling the conduct of a planned interim
efficacy data analysis, and we remain committed to supplying Neovastat to
patients currently taking part in the trial. Results from this analysis will
enable us to determine the future development of Neovastat", said Gilles Gagnon,
President and Chief Executive Officer at AEterna Zentaris.
ABOUT NEOVASTAT AND THE NCI PHASE III TRIAL IN NSCLC
Neovastat, an orally-bioavailable antiangiogenic product is currently in a Phase
III clinical trial for the treatment of NSCLC in combination with radiotherapy
and chemotherapy. Sponsored by the US National Cancer Institute (NCI), this
randomized, double-blind, placebo-controlled trial involves patients with
inoperable Stage IIIA and IIIB NSCLC. The study's objective is to evaluate the
efficacy of Neovastat and determine if the drug will increase median patient
survival time by 25%. This trial was initiated in 2000 and to date, 380 patients
have been recruited. An interim efficacy analysis to be performed at 320 events
has been planned in agreement with the U.S. NCI. As of today, the number of
events stands at 260.
ABOUT AETERNA ZENTARIS INC.
AEterna Zentaris Inc. is a growing global biopharmaceutical company engaged in
the discovery, development and marketing of therapies for cancer and endocrine
disorders.
AETERNA ZENTARIS LOGO
AEterna Zentaris also owns 48.4% of the equity of Atrium Biotechnologies Inc.
(TSX: ATB.sv) and 64.8% of its voting rights. Atrium is a developer,
manufacturer and marketer of science-based products for the cosmetics,
pharmaceutical, chemical and nutritional industries.
News releases and additional information are available at
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.
-30-
CONTACTS
MEDIA RELATIONS
Paul Burroughs
(418) 652-8525 ext. 406
paul.burroughs@aeternazentaris.com
----------------------------------
INVESTOR RELATIONS
Jenene Thomas
(418) 655-6420 or
(908) 996-3154
jenene.thomas@aeternazentaris.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: February 17, 2006 By:/s/Mario Paradis
----------------------------------------------
Mario Paradis
Senior Finance Director and Corporate Secretary