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Biomira Phase II Colorectal Trial Results Update (Theratope vaccine)   Message List  
Reply | Forward Message #1017 of 1454 |
News Release
BIOMIRA PHASE II COLORECTAL TRIAL RESULTS UPDATE

EDMONTON, ALBERTA, CANADA: March 12, 2004
EDMONTON, ALBERTA, CANADA — March 12, 2004 — Biomira Inc.
(Nasdaq:BIOM) (TSX:BRA) today provided an update of data from the
Phase II Theratope® vaccine colorectal study of 20 patients. A Kaplan-
Meier Survival and Time to Disease Progression Curve of the 20
colorectal cancer patients who received combination chemotherapy plus
Theratope in the featured study showed a median survival of 17.8
months and a median time to disease progression of 8.4 months. The
median time to disease progression remains unchanged from data
reported in June 2003. The trial was designed to evaluate the safety
of Theratope in patients with metastatic colorectal cancer, as well
as to evaluate the ability of the vaccine to induce an immune
response in patients when given in combination with first-line
chemotherapy. Although the trial was not designed to evaluate
survival benefit in these small numbers, it indicates a positive
trend in the patients followed. Biomira had reported earlier that the
Phase II study of Theratope in the treatment of metastatic colorectal
cancer showed that patients are capable of mounting an immune
response to the investigational vaccine while receiving concurrent
chemotherapy. "Colorectal cancer is the third most common cancer
found in men and women in North America," said Charles Butts, MD,
Cross Cancer Institute, Edmonton, Alberta and Lead
Investigator. "Although the death rate has been dropping due to
earlier diagnosis and improved treatments, we need to continue to
find innovative ways to treat this disease. This trial was an
important step in determining if Theratope could one day be such a
treatment alternative." "We are encouraged with the results of this
trial, which was an opportunity to gather data using Theratope in
combination with chemotherapy," said Alex McPherson, MD, PhD,
President and CEO of Biomira Inc. "As reported in June of 2003 the
trial accomplished its goals, showing the vaccine to have a good
safety profile and having the ability to induce an immune response.
Although not a study endpoint, this additional survival data will be
useful in finalizing decisions for next steps with Theratope. We
continue to follow patients for additional clinical data." Adverse
Events No unexpected adverse events related to the vaccine have been
reported to date. Injection site reactions have been documented,
including ulcerations in four patients. About the Companies With more
than 34,200 employees in 53 countries, the Merck Group generated
sales of EUR 7.2 billion in 2003. Founded in 1668 in Darmstadt,
Germany, Merck KGaA aims to be a world leader in its core businesses
of pharmaceuticals and chemicals. Merck groups its operating
activities under Merck KGaA, in which the Merck family holds 74 per
cent and the remaining 26 per cent is publicly traded. The former
U.S. subsidiary, Merck & Co., has been a completely independent
company 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. 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™. Contacts: Bill Wickson Manager, Public Relations 780-490-
2818 After hours contact: bwickson@... 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, 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 Tel: (780) 450-3761 Fax: (780) 463-0871 http://www.biomira.com




Fri Mar 12, 2004 9:47 pm

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News Release BIOMIRA PHASE II COLORECTAL TRIAL RESULTS UPDATE EDMONTON, ALBERTA, CANADA: March 12, 2004 EDMONTON, ALBERTA, CANADA — March 12, 2004 —...
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Mar 12, 2004
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