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Theratope Phase II Trial Results Updated
EDMONTON, March 12 /PRNewswire-FirstCall/ -- Biomira Inc. (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"
No unexpected adverse events related to the vaccine have been reported to date. Injection site reactions have been documented, including ulcerations in four patients.
Source: Biomira Inc.