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 2005
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 September 22, 2005 - AEterna Zentaris Initiates
Multi-Center Phase II Trial of Perifosine in Combination with
Radiotherapy 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 INITIATES MULTI-CENTER PHASE II TRIAL OF PERIFOSINE IN
COMBINATION WITH RADIOTHERAPY IN NON-SMALL CELL LUNG CANCER
QUEBEC CITY, CANADA, SEPTEMBER 22, 2005 - AEterna Zentaris Inc. (TSX: AEZ;
Nasdaq: AEZS) today announced the initiation of a European multi-center Phase II
trial of perifosine, a novel, first-in-class, oral signal transduction
inhibitor, in combination with radiotherapy, in non-small cell lung cancer
(NSCLC). This exploratory randomized, double-blind, placebo-controlled trial
will assess the efficacy and safety of a 150 mg daily dose of perifosine when
combined with radiotherapy in 160 patients with inoperable Stage III NSCLC.
Patients will receive perifosine daily for 5 to 6 weeks, starting 7 days prior
to radiotherapy, and will be followed up for at least 12 months. The primary
endpoint of this trial will be the extent and duration of local control, i.e.
the absence of tumor recurrence or progression in the area that has been
irradiated.
The trial is being conducted in collaboration with the Netherlands Cancer
Institute. The lead investigator is Marcel Verheij, MD PhD, of the Department of
Radiation Oncology / Division of Cellular Biochemistry, at The Netherlands
Cancer Institute in Amsterdam.
Dr. Verheij was the lead investigator in a prior Phase I trial with perifosine
in combination with radiotherapy. Results of that trial were presented at the
American Society of Clinical Oncology (ASCO) annual meeting in June 2004. A
total of 21 radiotherapy-naive patients, of whom 17 had advanced non-small cell
lung cancer (1 Stage IIIA, 15 Stage IIIB, 1 Stage IV) and 14 had become
refractory to prior chemotherapy, received oral perifosine doses ranging from 50
mg to 200 mg/day concurrently with standard doses of radiotherapy. The trial
data demonstrated the following: (i) acceptable safety and tolerability, with
150 mg/day established as the dose recommended for use in subsequent clinical
trials; (ii) dose limiting toxicity (nausea/vomiting) at 200 mg/day; (iii) no
bone marrow toxicity; and (iv) preliminary evidence of anti-tumor activity at
all dosage levels, including complete or partial responses (complete
disappearance and decreased tumor size, respectively), or stable disease, with a
median follow-up for responders of 8 months.
Importantly, in the cohort of 10 patients who were treated with 150 mg/day
established as the dose recommended for and now used in this Phase II trial,
there were 3 complete responses (2 NSCLC and 1 esophageal cancer), 3 partial
responses (2 NSCLC and 1 prostate cancer), and
AETERNA ZENTARIS
4 patients with stable disease. In addition, a patient with bladder cancer who
received 50 mg/day perifosine had an unexpected finding, namely a long-lasting
complete response.
"There is sound scientific, preclinical and early clinical rationale for using
perifosine to increase the efficacy of radiotherapy while maintaining favourable
tolerability and avoiding overlapping toxicity", said Dr. Jurgen Engel,
Executive Vice President, Global R&D and Chief Operating Officer at AEterna
Zentaris. "The initiation of this trial is a significant step in further
exploring the potential of perifosine as an important therapeutic approach that
can improve the outcomes of advanced NSCLC patients treated with radiotherapy."
Gilles Gagnon, President and Chief Executive Officer at AEterna Zentaris added,
"This large Phase II trial assessing perifosine in combination with
radiotherapy, in addition to ongoing studies by our North American partner Keryx
Biopharmaceuticals with perifosine in monotherapy and in combination with
chemotherapy, are all aimed at establishing perifosine as a potential
breakthrough cancer drug and reflect our commitment in building a solid oncology
franchise at AEterna Zentaris."
ABOUT PERIFOSINE
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. To date,
approximately 350 patients have been treated with perifosine at various doses
and schedules. From a clinical safety perspective, no dose-limiting toxicity,
other than gastro-intestinal toxicity, has been observed.
Perifosine has demonstrated single agent anti-tumor activity in Phase I and
Phase II studies. As a single agent, perifosine was the object of a large
screening Phase II program funded by the U.S. National Cancer Institute in
collaboration with AEterna Zentaris' North American partner, Keryx
Biopharmaceuticals (Nasdaq: KERX). Finding from these screening studies led
investigators to conclude that perifosine in monotherapy could be further
investigated in soft tissue sarcoma, melanoma as well as breast, prostate and
non-small cell lung cancer, while it was advised not to pursue studies with
perifosine in monotherapy in head and neck and pancreatic cancer.
Keryx has initiated a large Phase II trial program with perifosine. In
monotherapy, foreseen indications are non-small cell lung cancer, prostate
cancer and soft tissue sarcoma. In combination therapy, studies have been or
will soon be initiated with agents such as Gemcitabine (pancreatic cancer),
Paclitaxel/Taxol, Docetaxel/Taxotere, as well as with biologic agents such as
Herceptin in breast cancer.
ABOUT NON-SMALL CELL LUNG CANCER
Non-small cell lung cancer is the most common form of the disease and accounts
for almost 80 percent of all lung cancers. According to the World Health
Organization, there are more than 1.2 million cases of lung and bronchial cancer
worldwide each year. It is estimated that more than 173,000 people will be
diagnosed with lung cancer in the United States in 2005. According to the
National Cancer Institute, lung cancer is the leading cause of cancer deaths in
the United States and is responsible for nearly 30 percent of cancer deaths in
this country.
2
AETERNA ZENTARIS
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 also owns 50.03% of Atrium Biotechnologies Inc. (TSX: ATB.sv),
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
Ginette Vallieres
(418) 652-8525 ext. 265
ginette.vallieres@aeternazentaris.com
-------------------------------------
EUROPE
Matthias Seeber
+49 69 42602 3425
matthias.seeber@aeternazentaris.com
-----------------------------------
3
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 22, 2005 By: /s/ Mario Paradis
------------------------ -------------------------------------
Mario Paradis
Senior Finance Director and Corporate
Secretary