Biomira Phase II Colorectal Trial Results for Theratope(R) Vaccine to be Presented at 2003 American Society of Clinical Oncology (ASCO) Meeting Wednesday March 19, 8:30AM
Theratope Phase III Breast Cancer Demography Abstract Accepted for Publication In ASCO Meeting Proceedings Publication
EDMONTON, March 19 /PRNewswire-FirstCall/ - Biomira Inc. (Nasdaq:BIOM - News; TSX:BRA - News) announced today that data from the Company's Phase II Theratope® vaccine trial in metastatic colorectal cancer will be presented as a poster presentation at the 2003 Annual Meeting of ASCO. The meeting will take place in Chicago, IL, May 31-June 3.
The 20-patient colorectal trial completed enrolment in October 2002. The trial was conducted at the Cross Cancer Institute, Edmonton, AB. The lead investigator and ASCO presenter is Dr. Charles Butts of the Cross Cancer Institute. The trial was designed to evaluate the safety of the vaccine in patients with metastatic colorectal cancer, as well as to evaluate the ability of the vaccine to induce an immune response in these patients when given in combination with first line chemotherapy. The 2003 Annual Meeting abstracts are expected to be publicly available immediately following the meeting on Tuesday, June 3, 2003.
"ASCO received more than 3,700 abstracts this year for review by the Scientific Program Committee. We are very pleased that Dr. Butts' abstract was accepted and this will be the venue for presenting the results from this Phase II trial. This was our first opportunity to accumulate data using Theratope in combination with chemotherapy.. We will be closely studying the results of this trial as we await the final results from our Phase III Theratope trial in 1,030 women with metastatic breast cancer. We anticipate those Phase III results to be announced towards the end of the first half of 2003, " said Alex McPherson, MD, PhD, President and CEO of Biomira.
Biomira has also been notified that the Phase III demography data from the breast cancer study will be included in the 2003 ASCO Meeting Proceedings abstract publication. This abstract was submitted by the Phase III trial's lead investigator Dr. David Miles of Guy's Hospital in London, England.
Biomira and Merck KGaA completed enrolment in the Phase III Theratope 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 the timing is based on when the events occur. The events, following the completion of five Data Safety Monitoring Board reviews, are occurring in accordance with the original trial assumptions.
In addition to the 1,030 women in the Phase III trial, more than 400 patients with adenocarcinomas have been treated with Theratope, mostly in Phase II trials.
The ASCO Annual Meeting is the premier educational and scientific event for oncology professionals. The 2003 meeting is expected to attract more than 25,000 attendees from all over the world. ASCO is the world's leading professional organization representing physicians who treat people with cancer. ASCO's members set the standard for patient care worldwide, and lead the fight for more effective cancer treatments, increased funding for clinical and translational research, and, ultimately, cures for the many different cancers that strike 1.2 million people in the U.S. alone each year.
Biomira's collaborator for Theratope 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.
Source: Biomira Inc. |
