PRESS RELEASE
FOR IMMEDIATE RELEASE
Æterna Presents Status
on Neovastat Phase III Trials
in Kidney Cancer and Lung Cancer
Presentations by Dr. Bernard Escudier and Dr. Charles Lu at
the American Society of Clinical Oncology Meeting in Chicago
Chicago, Illinois, June 2, 2003 –
Dr. Bernard Escudier, Head of the Immunotherapy Unit at Institut
Gustave-Roussy in Paris, France and lead investigator in Europe
for Æterna Laboratories (Nasdaq: AELA, TSX: AEL) Neovastat
Phase III trial in renal cell carcinoma gave a status report
on the trial during a presentation today at the American Society
of Clinical Oncology (ASCO) Meeting in Chicago. More than
20,000 oncologists and scientists attend this meeting each
year. Dr. Charles Lu of the M.D. Anderson Cancer Center in
Houston, Texas and lead investigator for Æterna’s Phase III
trial in lung cancer also gave a status on this trial.
Current Phase III trial in kidney cancer
Æterna
is currently conducting a double-blind randomized placebo
controlled Phase III trial for renal cell carcinoma with its
lead antiangiogenic compound, Neovastat, involving 302 patients.
Patient recruitment was completed in December 2001 and the
trial is still at the patient survival monitoring stage, increased
patient survival time being the primary endpoint of the study.
Following discussions with the FDA (USA), Health Products
and Food Branch (Canada) and Medicines Control Agency (UK),
analysis of the trial’s database will start when the number
of deceased patients has reached 230. Furthermore, it has
been agreed with these health authorities that should that
number not be reached by September 30, 2003, analysis of the
trial’s database would begin at that time and all patients
still taking part in the trial would receive Neovastat. Dr.
Escudier announced that as of today, the number of deceased
patients stands at 218. Trial results will be available during
the current year.
“The
trial is still ongoing and on three occasions, the Data Safety
Monitoring Board (DSMB) stated that the study could continue
without adjustments since no safety concerns have been reported,”
explained Dr. Escudier. The DSMB is an independent body of
oncologists and statisticians responsible for evaluating patient
safety and ensuring the integrity of the trial. “Confirming
Neovastat's favourable safety profile in patients suffering
from serious and potentially life-threatening conditions is
a valuable asset in developing a new anticancer drug, especially
when it has to be taken on a chronic basis,” concluded Dr.
Escudier.
Gilles
Gagnon, President and Chief Executive Officer at Æterna added,
“We are at an exciting and also important stage of Neovastat’s
development. Positive results from this study could allow
us to reach our goal which is to bring to market a self-administered
oral drug that is not only efficient in fighting cancer but
also almost devoid of debilitating side effects so as to enhance
patient quality of life.”
Neovastat positive results in prior Phase I/II trial
in kidney cancer
In
March, 2001, Æterna presented results of a Phase I/II kidney
cancer trial with Neovastat on patients suffering from metastatic
renal cell carcinoma and refractory to standard therapies
at the Annual Meeting of the American Association for Cancer
Research (AACR) in New Orleans. Results showed a statistically
significant two-fold increase (p<0.01) in median survival
time for patients who had received a higher dose of Neovastat.
Median survival time for patients treated with a twice-daily
dose of 30mL of Neovastat was 7.1 months compared to 16.3
months for patients receiving a twice-daily dose of 120mL.
These results were published last year in the European scientific
review Annals of Oncology. “Æterna is generating highly
credible data with Neovastat which seem encouraging in the
development of this new approach in fighting cancer,” said
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, as well as lead
investigator in Canada for the current Phase III trial in
kidney cancer.
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 cases and are associated with a large number of
serious side effects.
Current Phase III trial in lung cancer
Æterna is also conducting
a Phase III trial with Neovastat in non-small cell lung cancer.
Sponsored by the U.S. National Cancer Institute (NCI), the
study is being held in approximately 40 hospital centers in
the United States and Canada. Patients are receiving chemotherapy
and radiotherapy treatments in combination with a placebo
or Neovastat and the main endpoint is an increase in median
survival time. At the current ASCO meeting, Dr. Charles Lu
of the M.D. Anderson Cancer Center in Houston, Texas and lead
investigator of this study for the United States, announced
that as of today, 240 patients have been enrolled out of a
total of 760. He also outlined Neovastat’s excellent safety
profile following recently obtained data.
Neovastat positive results in prior Phase I/II trial
in lung cancer
Back
in September 1999, at the 10th European Cancer Conference
in Vienna (ECCO 10), Æterna had divulged results of an open-label,
non-small cell lung cancer Phase I/II study. Results showed
that higher doses (240 mL per day) of Neovastat significantly
increased (p<0.02) the median survival time by 33% as compared
to patients receiving lower doses. Results were published
in early 2003 in Clinical Lung Cancer.
About Æterna Laboratories Inc.
Æterna
is a biopharmaceutical company focused on the development
of novel therapeutic treatments, mainly in oncology and endocrinology.
The product pipeline includes 12 products ranging from preclinical
stage up to marketing. Æterna has strategic worldwide partners
such as Access Oncology, Ardana Bioscience, Baxter Healthcare
S.A., German Remedies Ltd., Grupo Ferrer Internacional, Hainan
Chang An Pharmaceutical ltd, LG Life Sciences Ltd., Mayne
Group, Medac GmbH, Nippon Kayaku, Serono International S.A.,
Shionogi & Co. Ltd, Solvay Pharmaceuticals B.V. and Teikoku
Hormone Mfg. Co. Ltd.
Æterna
owns 100% of the biopharmaceutical company, Zentaris GmbH,
based in Frankfurt, Germany.
Æterna
also owns 61.8% of Atrium Biotechnologies Inc., which develops
and markets nutritional supplements, as well as active ingredients
and fine chemicals intended for the cosmetics, nutrition,
fine chemicals and pharmaceuticals industries. Atrium markets
over 500 products in 20 countries to industry leaders such
as Estée Lauder, L'Oréal, Clarins, Chanel, Avnetis, SanofiSynthelabo
and Nestlé.
Æterna
and its entities have 270 employees in Canada and Europe.
Æterna
shares are listed on the Toronto Stock Exchange (AEL) and
the NASDAQ National Market (AELA).
News
releases and additional information about Æterna are available
on its Web site at www.aeterna.com.
PS. For more information on the Phase III trial in non-small cell lung cancer,
call
1-888-349-3232.
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 -
CANADA
Media Relations:
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Burroughs Jacques
Raymond
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