Obviously, gave a very good presentation this morning....
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Biomira Presents At 3rd Annual Walker's Cay Colloquium On Cancer Vaccines And ImmunotherapyCompany Completes Enrolment of THERATOPE(R) Vaccine Trial
EDMONTON, Mar 9, 2001 /PRNewswire via COMTEX/ -- Biomira Inc. (NASD: BIOM) (TSE: BRA) announced today that the Company presented its experiences in developing new immunotherapy treatments against cancer at the 3rd Annual Walker's Cay Colloquium on Cancer Vaccines and Immunotherapy. The meeting was hosted by the Albert B. Sabin Vaccine Institute and Chaired by the Institute's, Dr. H.R. Shepherd.
The Colloquium's purpose is to foster an intensive yet relaxed discussion of ideas and data to stimulate development of cancer vaccines. It is co- chaired by Ralph Reisfeld, PhD, from The Scripps Research Institute and Jeffrey Schlom, PhD, from the US Department of Health and Human Services. Each year, the Sabin Vaccine Institute, a non-profit public organization, organizes a scientific meeting featuring the foremost vaccinologists, tumour biologists, immuno-biologists, statisticians and oncologists, to continue the vaccine work envisioned by its founder Dr. Albert Sabin.
Representing Biomira, Dr. Grant MacLean, Vice President Clinical and Regulatory Affairs, presented on the topic, "Synthetic Cancer Vaccines - Immunogenic, But How to Assess Efficacy?". Since 1990, Biomira has tested four different synthetic vaccines in clinical trials in several different indications.
"This is a premier event with world-renowned scientists and we are delighted that Dr. MacLean was asked to participate. Our presence speaks to the leadership role we have undertaken in this important area of clinical investigation," commented President and CEO Alex McPherson, MD, PhD.
During his presentation Dr. MacLean announced that enrolment of 950 patients is complete in the Company's Phase III clinical trial with THERATOPE(R) vaccine for metastatic breast cancer. The randomized, double- blind trial began in late November 1998.
"This is a major milestone for our Company," continued Dr. McPherson. "We believe this accomplishment positions Biomira as a world leader bringing forth novel immunotherapeutic approaches for the treatment of cancer."
Dr. MacLean explained that survival studies take time and it is an important endpoint to the development of new immunotherapeutics. He noted that there may be relevant or meaningful surrogates for clinical efficacy that can be used to expedite clinical development of immunotherapeutics through Phase I and II clinical trials.
The THERATOPE(R) vaccine Phase III trial, conducted in approximately 120 sites worldwide, is designed to determine whether THERATOPE(R) vaccine can delay disease progression and increase survival in women with metastatic breast cancer.
Designed foremost as a survival study, the THERATOPE(R) vaccine trial includes interim analyses of time-to-disease progression and survival in order to maximize the possibility of success at the earliest possible time. The precise timing of the first interim analysis, as well as the second and the final analysis, are dependent upon a statistical model that requires a pre-determined number of events in each of the two primary endpoints to occur, (disease progression and survival). The first analysis may be initiated as early as the third quarter of 2001.
Biomira is in advanced discussions for a potential corporate alliance for further development of THERATOPE(R) vaccine, as well as its second lead product candidate, BLP25 vaccine which is currently in a Phase IIb clinical trial for non-small cell lung cancer. Discussions are proceeding aggressively and it is the Company's hope to complete a deal by the end of the first quarter of 2001, or shortly thereafter.
Biomira is a biotechnology company specializing in the development of innovative therapeutic approaches to cancer management. The 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). |
