Æterna: 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 /PSA Rising / June 26, 2001 - ?terna 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?Universit? de
Montr?al (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 ?terna. "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
?terna'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, ?terna?s Vice
President and Chief Operating Officer.
More about the trial
As part of ?terna?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 ?terna and Neovastat/?-941
?terna Laboratories Inc. is a Canadian biopharmaceutical company
and a frontrunner in the field of antiangiogenesis. Its lead product,
Neovastat/?-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).
?terna is listed on the Toronto Stock Exchange under the symbol
AEL and on Nasdaq under the symbol AELA.
?terna?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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