LOGO OF
AETERNA LABORATORIES INC.
PRESS RELEASE
For Immediate Release
AETERNA'S NEOVASTAT SHOWS ABILITY TO INCREASE THE ANGIOSTATIN LEVEl
IN MICE WITH IMPLANTED HUMAN BRAIN CANCER CELLS
DATA ON THIS ADDITIONAL MECHANISM OF ACTION PRESENTED AT ASCO
MEETING IN SAN FRANCISCO
SAN FRANCISCO, CALIFORNIA , MAY 14, 2001 - Today, AEterna Laboratories Inc.
(NASDAQ: AELA, TSE: AEL) presented new data showing that Neovastat/AE-941 is
able to increase the level of angiostatin in mice with implanted human
glioblastoma, a form of brain cancer. Results on this additional mechanism of
action of Neovastat were presented in San Francisco at the American Society of
Clinical Oncology (ASCO) Annual Meeting on "New Drugs in Cancer Therapy" by
Professor Francois Berger, MD, PhD, neuro-oncologist and investigator of this
study at the INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM),
in Grenoble, France.
The study consisted in injecting human glioblastoma cells (cancer cells) into
the brain of nude mice. The mice were then given Neovastat in order to test its
antitumoral activity. Not only did results show an antitumoral activity in
Neovastat, but it also uncovered a new element of its activity which increases
tissue type Plasminogen activator (tPA), an enzyme involved in the production of
angiostatin. This increased tPA activity resulted in an increase in endogenous
(produced by the body) angiostatin at the tumor site.
"These results are significant since this model is very aggressive and few
agents are capable of improving survival time," declared Dr. Berger.
"Neovastat's activation of tPA translates into a multifunctional impact
including inhibition of angiogenesis and tumor infiltration. These two effects
might have an important contribution in improving survival in this model."
"Glioblastomas are one of the most vascularized tumor and are VEGF-dependent.
The use of an antiangiogenic agent containing several mechanisms of action, such
as Neovastat, may prove effective in increasing survival time in glioblastoma
patients," added Dr. Berger.
"Neovastat does not contain angiostatin, but rather agents which induce the
production of endogenous angiostatin at the tumor site," said Dr. Pierre
Falardeau, AEterna's Vice President of Scientific Affairs. "This particular
mechanism of action further strengthens Neovastat's position as a unique
angiogenesis inhibitor with multiple mechanisms of action since it has been
previously shown to block the VEGF (Vascular Endothelial Growth Factor)
signaling pathway, selectively inhibit matrix metalloproteinases (MMPs 2, 9 and
12) and induce endothelial cell apoptosis (programmed cell death). Therefore,
instead of blocking only one of the multistep process of angiogenesis,
Neovastat's several mechanisms of action could act together in a synergistic
fashion to induce a more complete inhibition of angiogenesis," concluded Dr.
Falardeau.
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
that block angiogenesis -- the process involved in the formation of new blood
vessels which are needed in order for cancer tumors and other pathological
conditions to develop.
Neovastat is currently used 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 125 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.
-30-
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
LOGO OF
AETERNA LABORATORIES INC.
P R E S S R E L E A S E
FOR IMMEDIATE RELEASE
AETERNA'S PATIENT RECRUITMENT HAS REACHED THE HALFWAY MARK
IN ITS PHASE III TRIAL IN RENAL CELL CARCINOMA
THIS STUDY IS CURRENTLY BEING HELD AT
SOME 50 INVESTIGATIVE CENTRES IN
NORTH AMERICA AND EUROPE
SAN FRANCISCO, CALIFORNIA, MAY 15, 2001 - AEterna laboratories inc. (NASDAQ:
AELA; TSE: AEL) announced today that patient recruitment in the Phase III trial
in renal cell carcinoma is more than half completed and trial is proceeding
according to schedule. Led by an international team of oncology experts, the
trial which involves 280 patients, is being conducted at some 50 investigative
centres in Canada, the U.S., and Europe. The study aims at evaluating the
efficacy of Neovastat in prolonging survival in patients who have failed to
respond to standard immunotherapy treatments. In march 2000, U.S. and Canadian
health authorities gave AEterna the green light to undertake this study, and in
the following months, European authorities followed suit. Results of the study
are expected by the end of 2002.
The current status of the ongoing Phase III trial was presented at an
Investigators' Meeting held during the American Society of Clinical Oncology
(ASCO) Annual Meeting in San Francisco by the three principal investigators: 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 at the
Department of Oncology and Medicine at McGill University in Montreal, Canada,
and Dr. Bernard Escudier, Head of Immunotherapy and Innovative TherapY Unit at
the Institut Gustave-Roussy in Villejuif, France.
"We are pleased to announce that patient recruitment has reached the halfway
mark in this trial. We wish to thank the investigators in North America and
Europe for their commitment which allowed AEterna to reach this important
milestone," emphasized Dr. Bukowski. "This study offers an exciting opportunity
to demonstrate a potential therapeutic benefit of angiogenesis inhibition,
leading to better management of renal cell carcinoma."
"We are encouraged by Neovastat's positive results obtained in Phase I/II trials
in advanced cancer patients," added Dr. Claude Hariton, Vice President, Clinical
and Regulatory Affairs of AEterna. "These data strongly support the current
development program in oncology and further increase the interest Neovastat has
created within the international medical community."
"We are confident that the support of recognized experts from both continents
will allow us to successfully complete our three ongoing pivotal clinical trials
within the targeted schedule, therefore improving our position to be among the
first to bring an angiogenesis inhibitor to market," concluded Gilles Gagnon,
Vice President and Chief Operating Officer at AEterna.
ABOUT RENAL CELL CARCINOMA AND THE NEOVASTAT ONGOING 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 the cases and are associated with a large number of serious
side effects.
AEterna's Phase III kidney cancer trial will involve approximately 280 patients
who have failed to respond to standard immunotherapy treatments. Patients will
fall into one of two groups: one will be given Neovastat, while the second group
will be given a placebo. Neither doctors nor patients will know who is receiving
the Neovastat treatment until the end of the study, which should be completed by
the end of 2002.
For further information regarding the trial, you may call 1-888-349-3232 in
North America (see AEterna's website at www.aeterna.com for more detailed
information).
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
that block angiogenesis -- the process involved in the formation of new blood
vessels which are needed in order for cancer 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 cancers 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 125 clinical institutions in Canada, the U.S. and in
several European countries.
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.
-30-
FOR MORE INFORMATION, CONTACT:
CANADA
Paul Burroughs
Director of Communications
AEterna Laboratories Inc.
Tel.: 418-652-8525, ext. 406
Fax: 418-577-7700
E-mail: paul.burroughs@aeterna.com
USA
Investor and Media Relations:
Ms. Lisa Lindberg
The Investor Relations Group Inc.
Tel.: 212-825-3210
Fax: 212-825-3229
E-mail: TheProTeam@aol.com
GERMANY
Investor Relations and Media
Ms. Ursula Fessele
Value Relations IR Services
Tel.: 49-6196-8800-218
Fax: 49-6196-8800-447
E-mail: u.fessele@vrir.de