To realize the full potential of cancer vaccines, corporations and research-oriented institutions and universities are forming partnerships. For example, Biomira, a Canadian pharmaceutical company pursuing cancer vaccines with basic science and clinical trials, has partnered with both Larry Kwak, M.D., Ph.D., and Jeffrey Schlom, Ph.D., of the National Cancer Institute. Other researchers, like Edgar Engleman, M.D., and Ron Levy, M.D., at Stanford, hope their published results will be of interest to other groups.
At Biomira, success seems imminent. The work that is furthest along is on the Theratope® vaccine, which is in phase III trials for metastatic breast cancer, said Mairead Kehoe, M.D., director of clinical trials.
Biomira enrolled patients into this trial from 120 sites worldwide, including the United Kingdom and other countries in Europe, Australia, New Zealand, Canada, and the United States. "Because this is a phase III (trial), its in the last stage of its development," said Kehoe. Looking at the results of the phase II trials of Theratope has led to cautious optimism. "If you look at our phase II data, we saw quite a positive effect," said Kehoe.
The company began enrolling patients in 1998 and does not expect results until mid-2003, but data released from the companys earlier studies show that with Theratope, patients lived 26.5 months compared with 9.2 months in a retrospective control group of patients. The early results placed Theratope on the FDAs fast track that expedites the approval process for drugs intended to treat life-threatening conditions.
"Our goal is to open up the door, if you will, to demonstrate feasibility and the potential of these approaches," said Engleman, "Then it has to go to much larger, expensive programs that are either going to be carried out by companies, organized trial groups, or NCI. Were not equipped to do those larger studies, nor are we funded to do them."
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