Biomira Completes Enrolment of Phase II Pilot Study of THERATOPE(R) Vaccine for Metastatic Colorectal Cancer
EDMONTON, Oct. 8 /PRNewswire-FirstCall/ - Biomira Inc. (Nasdaq: BIOM) (TSX: BRA) announced today that the Company has completed enrolment of its Phase II pilot study of THERATOPE(R) vaccine for metastatic colorectal cancer. The 20 patient study was initiated in February 2002. Data from this trial is expected to be analyzed and available in mid-2003.
The THERATOPE(R) vaccine Phase II trial, conducted at the Cross Cancer Institute in Edmonton by lead investigator Dr. Charles Butts, from the Alberta Cancer Board, was designed to evaluate the safety of the vaccine in patients with metastatic colorectal cancer, as well as evaluating the ability of the vaccine to induce an immune response in these patients when given in combination with first line chemotherapy.
"Completing the enrolment of this trial is an important milestone for our Phase II THERATOPE(R) vaccine study in this indication," said Alex McPherson, MD, PhD, President and CEO of Biomira. "This is the first opportunity to accumulate data using THERATOPE(R) vaccine in combination with chemotherapy. Data from this trial will be used in planning further studies using THERATOPE(R) vaccine in colorectal cancer."
Colorectal cancer is the third most common cancer in men and women. In North America, colorectal cancer accounts for over 55,000 deaths each year with an estimated 135,000 new cases in 2001, according to the American Cancer Society.
Biomira and Merck KGaA completed enrolment in a Phase III THERATOPE(R) vaccine clinical trial in metastatic breast cancer for 1,030 women at 120 clinical sites in 10 countries in March 2001. This Phase III trial is a double-blinded, randomized, controlled trial. The final analysis is event-driven and is expected to commence in mid-2003. Biomira had originally announced the final analysis would be conducted in the second half of 2003. As we have previously stated, the final analysis will be based on when the events occur. The events are occurring in accordance with the original trial assumptions. However, since collecting and cleaning the bulk of the data for the interim analysis, it is felt an answer at the final analysis can be obtained faster than originally planned.
Biomira's collaborator for THERATOPE(R) vaccine is Merck KGaA, of Darmstadt, Germany, founded in 1668. Merck KGaA has positioned itself to be on the cutting edge of cancer research with an oncology portfolio based on four technology platforms - monoclonal antibodies, 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(TM).
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 of clinical trials, availability, or adequacy of financing, the sales and marketing of commercial products or the safety and 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.
SOURCE Biomira Inc.
/CONTACT: Biomira Company Contacts: Bill Wickson,
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