Press Release Mar. 9, 2000:
newswire.ca
AEterna has green light to begin Phase III trial of AE-941/Neovastat in kidney cancer
patients in the United States
QUEBEC CITY, March 9 /CNW/ - AEterna Laboratories Inc. (TSE: AEL)
announced today that it has the green light to start its Phase III trial of
AE-941/Neovastat on the treatment of kidney cancer patients in the United
States. Patient recruitment is expected to start shortly after the
investigator meetings that are scheduled for the end of this month. This
final-stage study, to be conducted at some 40 hospitals throughout Canada, the
United States and select countries in Europe, will evaluate the efficacy of
AEterna's antiangiogenic treatment Neovastat in prolonging the life of
patients with progressive renal cell carcinoma. Renal cell carcinoma is the
most common type of kidney cancer.
``Currently available therapies for renal cell carcinoma are effective in
less than 20% of cases and these treatments are associated with many serious
side effects,' said Dr. Ronald Bukowski, Director of the Experimental
Therapeutics Program of the Cleveland Clinic Cancer Center, in Cleveland,
Ohio, and the principal investigator for the U.S. portion of this Phase III
trial. ``What this trial seeks to determine is whether Neovastat can increase
the survival time of kidney cancer patients where the disease is progressing
following standard therapies.'
AEterna's Phase III kidney cancer trial will involve approximately 270
patients who have failed to respond to standard therapies. Patients will fall
into one of two groups: one will be given the 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 within two years.
``We will be ready to begin patient recruitment very shortly,' said
AEterna's Senior Vice President and Chief Operating Officer, Yves Rosconi.
``This trial is part of our early-to-market strategy for Neovastat. By
targeting cancers, like renal cell carcinoma, where there are currently
limited therapies available, we should be able to seek fast-track approval
from the regulatory agencies with a successful trial.'
ABOUT NEOVASTAT
Neovastat is a novel orally bioavailable antiangiogenic product with
multiple mechanisms of action that block angiogenesis, the formation of new
blood vessels - a necessary element in the development of cancer and other
medical disorders. Neovastat's proposed method of action includes the
inhibition of the enzyme matrix metalloproteinases (MMPs), as well as
interaction with the VEGF receptor sites to prevent the reception of
angiogenic signals from cancerous cells. 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.
ABOUT RENAL CELL CARCINOMA
There are about 34,000 new cases of renal cell carcinoma in North America
each year. The five-year mortality rate for this disease is approximately
90%.
ABOUT AETERNA
AEterna Laboratories Inc. is a Canadian biopharmaceutical company focused
on the development of new therapies to treat a variety of conditions,
principally cancer. AEterna's lead compound, Neovastat, is an angiogenesis
inhibitor being investigated in three major therapeutic areas: oncology,
dermatology and ophthalmology. The company also owns 77.8% of Atrium
Biotechnologies Inc., a leader in the development of active ingredients used
in cosmetics and nutrition products.
AEterna is listed on the Toronto Stock Exchange under the symbol AEL.
AEterna's news releases and additional information are available on its
Web site at www.aeterna.com.
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For further information: Janet Craig, Director of Corporate
Communications and Investor Relations, Direct: 416-229-4075,
Bus: 418-652-8525, Fax: 418-652-0881, E-mail: janetacraig@home.com
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