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 May 2002
AETERNA LABORATORIES INC.
(Translation of registrant's name into English)
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-__
EXHIBIT INDEX
EXHIBIT DESCRIPTION PAGE
1. Press release dated May 21, 2002 relating to Neovastat's favorable 1
safety profile in Phase III trials confirmed by independent safety
monitoring boards.
[GRAPHIC OMITTED]
PRESS RELEASE
FOR IMMEDIATE RELEASE
AEterna: Neovastat's Favorable Safety Profile in Phase III Trials
Confirmed by Independent Safety Monitoring Boards
ORLANDO, FLORIDA, MAY 21, 2002 - AEterna Laboratories Inc. (NASDAQ: AELA; TSX:
AEL) announced today that the planned safety analysis of its two Phase III
trials in renal cell carcinoma, a form of kidney cancer and non-small cell lung
cancer conducted with Neovastat, have been positively completed.
"The Data Safety Monitoring Board (DSMB) involved in each trial stated that both
studies can continue without adjustment since the safety profile of the study
drug is acceptable and no safety concerns have been reported", said Dr. Claude
Hariton, AEterna's Vice President and Chief Medical Officer, at a meeting on the
current status of the ongoing Phase III trials, during the American Society of
Clinical Oncology (ASCO) Annual Meeting in Orlando, Florida. "Last December, a
first safety analysis on the Phase III renal cell carcinoma trial was also
favorable." The DSMBs are independent bodies of oncologists and statisticians
responsible for evaluating patient safety and ensuring the integrity of the
trials.
AEterna's current international Phase III trial in renal cell carcinoma aims to
increase survival time in patients who have failed to respond to standard
immunotherapy treatment. Recruitment of all 302 patients for the trial has been
completed and results are expected in the first quarter of 2003. The outcome of
a prior Phase I/II clinical trial in renal cell carcinoma had demonstrated a
statistically significant two-fold increase (p0.01) in median survival time for
patients who were administered an optimal dose of Neovastat. A peer-review on
the results of this Phase I/II trial will appear in an upcoming issue of ANNALS
OF ONCOLOGY.
Lead investigators for the renal cell carcinoma Phase III trial expressed
satisfaction regarding the conclusions of the second DSMB report on this trial.
In a joint statement, Dr. Ronald Bukowski, Director of Experimental Therapeutics
Program at the Cleveland Clinic Cancer Center in the United States, Dr. Gerald
Batist, Director of the McGill Centre for Translational Research in Cancer and
Professor in the Department of Oncology and Medicine at McGill University in
Montreal, Canada, as well as Dr. Bernard Escudier, Head of Immunotherapy and
Innovative Therapy Unit at the Gustave-Roussy Institute in Villejuif, France,
said, "Confirming Neovastat's favorable safety profile in patients suffering
from serious and potentially life-threatening conditions is a valuable asset in
its development as a new anticancer drug, especially when it has to be taken on
a chronic basis."
Gilles Gagnon, President and COO at AEterna Laboratories, added, "We are very
pleased with the DSMB conclusions about Neovastat's safety profile. They are in
line with our clinical strategy to develop a self-administered oral drug that is
not only efficient in fighting cancer but also devoid of debilitating side
effects so as to enhance patient quality of life when taking Neovastat alone or
in combination with other therapies."
ABOUT PHASE III RENAL CELL CARCINOMA TRIAL
Renal cell carcinoma is the most common type of kidney cancer in adults. There
are about 34,000 new cases of renal cell carcinoma in North America each year
and about 38,000 new cases in Europe. The five-year mortality rate for this
disease is approximately 90%. The therapies currently available are effective in
less than 20% of cases and are associated with a large number of serious side
effects.
AEterna's Phase III renal cell carcinoma cancer trial involves 302 patients who
have failed to respond to standard immunotherapy treatment and aims at
increasing patient survival time. It is currently being conducted in nine (9)
countries on the American and European continents. Recruitment of patients for
the trial has been completed and results are expected in the first quarter of
2003.
ABOUT PHASE III NON-SMALL CELL LUNG CANCER TRIAL
Lung cancer is the most prevalent form of cancer in men and women. The American
Cancer Society estimates that over 170,000 new cases will be diagnosed this
year, accounting for 14% of cancer diagnoses. Lung cancer is responsible for an
estimated 157,000 deaths in the U.S. in 2001, accounting for 28% of all cancer
deaths.
This Phase III clinical trial involving over 760 patients in approximately 50
sites across North America, strives to increase survival time of patients
receiving Neovastat in combination with chemotherapy and radiotherapy.
Currently, 160 patients have been enrolled in this trial which should be
completed in 2005.
The trial is sponsored by the U.S. National Institutes of Health in Bethesda,
Maryland. The lead investigators are Dr. Charles Lu, University of Texas M. D.
Anderson Cancer Center in Houston and Dr. William K. Evans, Cancer Care Ontario,
Toronto, Canada.
ABOUT AETERNA AND NEOVASTAT
AEterna Laboratories Inc. is a Canadian biopharmaceutical company and a
frontrunner in the field of angiogenesis inhibitors. The Company's efforts are
mainly focused on developing new cancer therapies.
AEterna's lead compound, Neovastat, is currently undergoing two Phase III
clinical trials for the treatment of lung and kidney cancer, and one Phase II
trial for treatment of multiple myeloma, a form of blood cancer. These clinical
trials are currently being conducted in more than 140 clinical institutions in
America and Europe.
AEterna shares are listed on the Toronto Stock Exchange (AEL) and the Nasdaq
(AELA).
News releases and additional information about AEterna are available on its Web
site at www.aeterna.com.
SAFE HARBOR STATEMENT
This press release contains forward-looking statements, which are 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 the business opportunities in
the pharmaceutical industry, uncertainties related to the regulatory process and
general changes in economic conditions. Investors should consult the Company's
ongoing 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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FOR MORE INFORMATION, CONTACT:
CANADA
MEDIA RELATIONS:
Paul Burroughs
Tel.: (418) 652-8525 ext. 406
Fax: (418) 577-7700
E-mail: paul.burroughs@aeterna.com
INVESTOR RELATIONS:
Jacques Raymond
Tel.: (418) 652-8525 ext. 360
Fax: (418) 577-7700
E-mail: jacques.raymond@aeterna.com
USA
The Investor Relations Group
Lisa Lindberg
Tel.: (212) 825-3210
Fax: (212) 825-3229
E-mail: TheProTeam@aol.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 LABORATORIES INC.
Date: May 21, 2000 By: /s/ Claude Vadboncoeur
--------------------------------
Claude Vadboncoeur
Vice President, Legal Affairs and
Corporate Secretary