Aeterna Announces Patient Recruitment Has Commenced for Phase Iii Trial of
AE-941/Neovastat in The Treatment of Kidney Cancer at 50 Sites in North
America And Europe



May 04, 2000

PR Newswire

QUEBEC, Quebec, May 4, 2000 /CNW-PRN via COMTEX/ -- AEterna Laboratories
(TSE: AEL) announced today that patient recruitment has begun for a Phase III clinical
trial of AEterna's antiangiogenic treatment, AE-941/Neovastat. Neovastat belongs to a
new class of drugs that aims to fight cancer in a new way by inhibiting the formation of
new blood vessels that supply cancerous cells with nutrients to grow.

As previously announced, this Phase III trial will take place at about 50 sites
across North America and Europe and will involve 270 patients with progressive renal
cell carcinoma, who have failed to respond to standard therapies. Patient recruitment
is expected to take approximately 12 months, and the trial is expected to be complete
within two years.

For further information regarding the trial, you may call 1-888-349-3232 (see
AEterna's website at www.aeterna.com for more detailed information).

``We are encouraged by Neovastat's preliminary trial results,'' said Dr. Ronald
Bukowski, Director of Experimental Therapeutics Program, Cleveland Clinic Cancer
Center and Principal Investigator for the U.S. portion of the trial. ``We welcome the
opportunity to investigate the new treatment approach that Neovastat offers. We are
always looking to find new and better treatments since there are few therapies
available to kidney cancer patients.''

``This study seeks to determine whether or not Neovastat can increase survival in
renal cell carcinoma patients that have failed standard therapy,'' said Dr. Bernard
Escudier, Head of Immunotherapy and Innovative Therapy Unit, Institut Gustave
Roussy, Villejuif, Principal Investigator for the European portion of the trial. ``Therapies
that are currently available to patients are effective in less than 20% of all cases, and
are associated with many side effects. The fact that Neovastat has been shown to be
extremely well tolerated by patients, and could help increase survival for this very hard
to treat cancer convinced me to participate in this trial.''

``The Montreal Jewish General Hospital had the opportunity to study the safety of
Neovastat on patients with many different types of cancer in a Phase /II study,'' commented Dr. Franois Patenaude, Assistant Professor of Medicine at McGill
University and The Montreal Jewish General Hospital, and Principal Investigator in
Canada. ``In addition to establishing the excellent tolerability and safety profile of
Neovastat, we were also able to observe cases of progressive renal cell carcinoma
tumor regression and stabilization. In order to demonstrate the real biological and
clinical efficacy and potential survival advantage of this novel agent, we have designed
a pivotal double-blind, randomized, placebo-controlled trial to demonstrate these most
important issues in a population of patients in which no other effective treatment is
available.''

``Our strategy is to be among the first to reach the market in this new area of
cancer treatment - antiangiogenesis. This Phase III trial for renal cell carcinoma, which
will last approximately two years, will be our first opportunity to receive market
approval for Neovastat,'' said Mr. Yves Rosconi, Senior Vice President and Chief
Operating Officer of AEterna Laboratories. ``Our data - both preclinical and clinical - to
date suggest that Neovastat, as a unique multifunctional antiangiogenic agent, could
have a broad application in a number of indications. We intend on exploring the use of
Neovastat in many oncology indications as well as other diseases that are
angiogenic-dependent.''

UNDERSTANDING ANGIOGENESIS

Angiogenesis is a scientific term for the formation of new blood vessels crucial to
the development of cancer and other diseases. The process involves developing new
blood vessels from existing ones by creating an opening in the existing blood vessel
walls, from which a new blood vessel can grow. The opening in the blood vessel is
created by enzymes called matrix metalloproteinases or MMPs by breaking down the
surrounding tissue. The walls of blood vessels are made up of endothelial cells which,
when activated by angiogenic proteins such as VEGF (Vascular Endothelial Growth
Factor), migrate towards the disease that sent out the angiogenic signals. The
endothelial cells then divide, and eventually, strings of new endothelial cells organize
into hollow tubes to form a new blood vessel that connects the disease to an existing
network of blood vessels.

NEOVASTAT - UNIQUE MULTIFUNCTIONAL MECHANISM OF ACTION

Neovastat is a unique orally bioavailable antiangiogenic product with multiple
mechanisms of action. Neovastat blocks the two main pathways of angiogenesis,
MMPs and VEGF. Most tumors secrete VEGF, which binds to specific receptor sites
on the wall of blood vessels and triggers the growth of new blood vessels. Recent
studies confirmed that Neovastat contains active components that specifically block
the receptors where VEGF binds. Studies also show that Neovastat regulates the
VEGF-induced proliferation of endothelial cells necessary in the growth of new blood
vessels. In addition, Neovastat has been shown to inhibit selective MMPs 2, 9 and 12,
which is involved in breaking down surrounding tissue and creating an opening for the
formation of new blood vessels.

Preclinical and clinical data suggest that Neovastat has an effect on diseases that
are dependent on angiogenesis. These data have also demonstrated an excellent
safety profile in the treatment of targeted diseases such as cancer, psoriasis and
age-related macular degeneration. Neovastat has already been given to more than 540
patients with various diseases. Some have taken the treatment for more than three
years.