LOGO OF
AETERNA LABORATORIES INC.
PRESS RELEASE
FOR IMMEDIATE RELEASE
AETERNA: PHASE I/II STUDY RESULTS IN PROSTATE CANCER CONFIRM NEOVASTAT'S SAFETY
PROFILE AND DOSE-RELATED ACTIVITY
Results presented at the Annual Meeting of the Canadian Urological Association
TORONTO, ONTARIO, JUNE 26, 2001 - AEterna Laboratories Inc. (TSE: AEL,
NASDAQ: AELA) announced today that results from a Phase I/II clinical
study in 48 evaluable patients suffering from metastatic refractory prostate
cancer, confirm Neovastat's safety profile and dose-related activity. Results
of the study, held in Canada and the United States, showed no dose-limiting
toxicity, excellent patient compliance while improved conditions or disease
stabilization were noted in patients as indicated by Prostate Specific
Antigen (PSA) levels. This dose-dependent benefit was noted in 20% of
patients given the low-doses of Neovastat and in 45% of patients
administered the high-doses. Furthermore, pain reduction or stability was
observed in over 80% of patients and global health status was stable or
improved in approximately 50% of patients. Results were presented at the
Annual Meeting of the Canadian Urological Association in Toronto, by
Dr. Fred Saad of the Centre Hospitalier de l'Universite de Montreal (CHUM) in
Canada.
"Results of this study are very encouraging," said Dr. Saad. "A
dose-dependent effect was often found in very ill patients and their
quality of life was improved. These findings further support the
ongoing clinical trials of Neovastat in oncology."
The study also corroborates results from prior Phase I/II clinical trials
which demonstrated Neovastat as a safe compound with clinical benefits. "In
Phase II trials in oncology, a statistically significant increase in median
survival time was found in metastatic renal cell carcinoma patients and in
non-small-cell lung cancer patients receiving a high dose of Neovastat,"
noted Dr. Claude Hariton, Vice President, Clinical and Regulatory Affairs at
AEterna. "All these positive results lead us to consider exploring the use
of Neovastat for many different cancer indications and by pursuing our
clinical development strategy which focuses on oncology, we have the
opportunity of being among the first to bring an antiangiogenic agent onto
the market," concluded Dr. Hariton.
To date, more than 700 patients have received Neovastat as part of
AEterna's clinical program in 140 clinical centers across Canada, the
United States and Europe. "Studies have repeatedly demonstrated that
Neovastat is a very convenient oral formulation which may be used safely
for different indications, thus representing a tremendous benefit for
cancer
patients and a potential market opportunity for our pharmaceutical
partners," said Gilles Gagnon, AEterna's Vice President and Chief Operating
Officer.
MORE ABOUT THE TRIAL
As part of AEterna's clinical Phase I/II development program, 48
evaluable patients with metastatic prostate cancer refractory to standard
therapies took part in the trial conducted across Canada and the United
States. Neovastat was used as a monotherapy treatment. Objectives of the
trial were to determine the maximum tolerated dose of Neovastat, its
safety profile and signs of clinical benefit after 84 days of treatment.
Based on Prostate Specific Antigen (PSA) levels (stable or decrease of at
least 25%), improved disease status or stable disease was noted in 17 out
of 38 patients (45%) receiving the highest doses and in 2 out of 10 patients
(20%) receiving the lowest doses.
Prostate cancer is one of the most common cancer in men. In North America, 1
out of 10 men will develop the disease at some point in his life, most after
age 65. In the United States, an estimated 198,100 new cases of prostate
cancer will be diagnosed in 2001, and 31,500 persons will die of the disease
according to the American Cancer Society.
ABOUT AETERNA AND NEOVASTAT/AE-941
AEterna Laboratories Inc. is a Canadian biopharmaceutical company and
a frontrunner in the field of antiangiogenesis. Its lead
product, Neovastat/AE-941, is being investigated in three major
therapeutic areas: oncology, dermatology and ophthalmology.
Neovastat is a novel antiangiogenic product with multiple mechanisms of
action (VEGF receptor, MMP's 2, -9, -12, apoptosis of endothelial cells, tPA
inducer to produce angiostatin) that blocks angiogenesis, the process
involved in the formation of new blood vessels which are needed in order for
cancerous tumors and other pathological conditions to develop.
Neovastat is currently investigated in two Phase III pivotal clinical trials
for the treatment of lung and kidney cancer as well as in a Phase II
pivotal trial for the treatment of multiple myeloma, a form of blood cancer.
These trials are currently held in more than 140 clinical institutions in
Canada, the U.S. and in several European countries. For more information,
please call 1-888-349-3232 (North America).
AEterna is listed on the Toronto Stock Exchange under the symbol AEL and
on Nasdaq under the symbol AELA.
AEterna's news releases and additional information 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 USA
Paul Burroughs Investor and Media Relations:
Director of Communications Ms. Lisa Lindberg
AEterna Laboratories Inc. The Investor Relations Group Inc.
Tel.: 418-652-8525, ext. 406 Tel.: 212-825-3210
Fax: 418-577-7700 Fax: 212-825-3229
E-mail: paul.burroughs@aeterna.com E-mail: TheProTeam@aol.com