Data Presented As Part of One of Two Poster Presentations at 2005
American Society of Clinical Oncology (ASCO) Annual Meeting
EDMONTON, May 16 /CNW/ - Biomira Inc. (Nasdaq:BIOM) (TSX:BRA) of
Edmonton, Alberta, Canada and Merck KGaA of Darmstadt, Germany, announced
today that a poster discussion on Saturday, May 14, 2005 at the ASCO meeting
detailed the updated annual survival results from the Phase IIb NSCLC study in
patients with Stage IIIB disease. The data were from the trial's last formal
analysis that was conducted in November 2004 and discussed in general terms in
December 2004. Dr. Nevin Murray, a Clinical Investigator with the Phase IIb
study, was the lead author on the poster. Dr. Murray is from the BC Cancer
Agency, Vancouver, British Columbia. His poster was entitled, "A Liposomal
MUC1 Vaccine for Treatment of Non-Small Cell Lung Cancer (NSCLC); Updated
Survival Results from Patients with Stage IIIB Disease". Dr. Charles Rudin of
Johns Hopkins led the discussion portion of the presentation.
At the time of the November 2004 survival update, conducted approximately
two years after the last patient had been enrolled in the trial, the median
survival of patients with Stage IIIB locoregional disease who received best
supportive care was 13.3 months and that the median survival had not yet been
reached for those of the same disease stage who received vaccine. This means
that more than 50 per cent of the patients on the vaccine arm in this subset
were still alive at that time. The difference in survival between the two
groups remains non-significant (p(equal sign)0.0924). However, the median
survival of the vaccine arm will be no less than 23 months and the hazard
ratio remains 0.5652 (A hazard ratio of less than one indicates a decrease in
the risk of death). The one-year, two-year, and three-year survival
differences continue to suggest a positive survival impact for those who
received vaccine.
"Despite the relatively small number of Stage IIIB patients in each arm
of the study, I believe the data support moving forward with a Phase III
trial, to see if we can show a statistically significant advantage for
patients in the vaccine arm," said Dr. Murray. "I look forward to
participating in that larger study as quickly as possible."
"We are very encouraged with the results of this trial," said Alex
McPherson, MD, PhD, President and CEO of Biomira Inc. "The two-year survival
data which show 33.3 per cent of patients on the best supportive care arm
remained alive, while 57.1 per cent of patients on the vaccine arm were still
alive. The three-year survival data are also very promising, but these data
are less mature."
Both Biomira(R) and our collaborator, Merck are keenly interested in
obtaining the median survival information from the Stage IIIB vaccinated
patients. Therefore, we plan to amend the protocol to allow further survival
documentation to be collected, as the trial was not originally designed with
this further analysis in mind. We estimate this analysis will be complete by
the end of 2005.
Another L-BLP25 investigator will present a second poster from the
Phase IIb study on May 17 at ASCO. Dr. Denis SouliGeres is from HFopital
Notre-Dame du CHUM Centre D'Oncologie in Montreal, Quebec. His presentation
entitled, "A Liposomal MUC1 Vaccine for Treatment of Non-Small Cell Lung
Cancer (NSCLC): Differences in QOL Assessments for Stage IIIBLR and IV
Patients," will be part of the poster session. "QOL" is defined as Quality of
Life.
In April, we announced the start of a L-BLP25 Phase II Safety Study to
assess the safety of the vaccine formulation that we expect to use in the
Phase III trial. This formulation incorporates manufacturing changes put in
place to help ensure the future commercial supply of the vaccine. The Phase II
Safety Study is expected to involve eight sites in Canada and will enroll up
to 20 men and women with NSCLC. We expect enrolment to be fully completed in
the third quarter of 2005. The large multi-national Phase III study is
expected to commence toward the end of 2005.
About Lung Cancer
In 2004, approximately 174,000 new cases of lung were diagnosed in the
U.S. - 54 per cent of them in men and 46 per cent in women. Approximately
160,000 people will have died of this disease in the U.S. alone in 2004.
Similar per capita rates of incidence and mortality occur in Canada. NSCLC
accounts for approximately 75 to 80 per cent of all primary lung cancers. At
the time of diagnosis, only 25 per cent of patients are potentially curable by
surgery.
About the Companies
Our key collaboration in developing therapeutic cancer vaccines is with
Merck KGaA. Merck is a global pharmaceutical and chemical company with sales
of EUR 5.9 billion in 2004, a history that began in 1668, and a future shaped
by 28,900 employees in 52 countries. Its success is characterized by
innovations from entrepreneurial employees. Merck's operating activities come
under the umbrella of Merck KGaA, in which the Merck family holds a 73 per
cent interest and free shareholders own the remaining 27 per cent. The former
U.S. subsidiary, Merck & Co., has been completely independent of the Merck
Group since 1917. Merck KGaA has built a strategic oncology portfolio by
developing and in-licensing product candidates in four areas -- monoclonal
antibodies, therapeutic vaccines, immunocytokines and angiogenesis inhibitors.
EMD Pharmaceuticals Inc., the U.S. affiliate of Merck KGaA, is a fully
integrated pharmaceutical company with an initial emphasis on launching new
products in oncology. Located in Durham, N.C., EMD focuses on meeting patient
and physician needs with pioneering pharmaceutical products and services.
Biomira is a biotechnology company specializing in the development of
innovative therapeutic approaches to cancer management. Biomira's commitment
to the treatment of cancer currently focuses on the development of synthetic
vaccines and novel strategies for cancer immunotherapy. We are The Cancer
Vaccine People(TM).
Abstract Numbers:
1. Abstract ID: 7037 - Scientific Program in the Lung Cancer I Poster
Discussion Abstract Title: A Liposomal MUC1 vaccine for treatment of
non-small cell lung cancer (NSCLC); updated survival results from
patients with stage IIIb disease Presenter: Dr. Nevin Murray
2. Abstract ID: 7209 - Scientific Program in the Lung Cancer General
Poster Session Abstract Title: A Liposomal MUC1 vaccine for treatment
of non-small cell lung cancer (NSCLC): Differences in QOL assessments
for Stage IIIBLR and IV patients
Presenter: Dr. Denis Soulieres
This release may contain forward-looking statements. Various factors
could cause actual results to differ materially from those projected in
forward-looking statements, including those predicting the timing and results
of clinical trials, whether promising or statistically significant results
here indicated will be replicated in larger trials which may follow,
availability or adequacy of financing, the sales and marketing of commercial
products or the efficacy of products. Although the Company believes that the
forward-looking statements contained herein are reasonable, it can give no
assurance that the Company's expectations are correct. All forward-looking
statements are expressly qualified in their entirety by this cautionary
statement.
BIOMIRA INC. 2011 - 94 St. Edmonton, AB, Canada T6N 1H1
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