The Medical Center has delayed clinical trials of a promising breast cancer vaccine.
About 30 percent of breast cancers involve tumors that express the Her-2/neu protein. The Medical Center's trials therefore involve a vaccine that works by using cells with sections of the Her-2/neu protein on their surfaces.
The immune system interprets these cells as foreign bodies and attacks the tumor cells that express the protein. This new treatment could potentially help the immune systems of patients with advanced diseases fight the cancer.
The Medical Center reported last October that it successfully conducted phase I trials, which included six patients and tested the treatment's toxicity. However, phase II trials, which were set to start early this year, have not yet begun.
Steve Gillis, chief executive officer of Corixa, the company that manufactures the peptide, said phase I trials are not yet complete. But Dr. Michael Morse, one of the researchers working with the vaccine, said the University was no longer enrolling patients for phase I research.
Morse, an associate in the department of hematology and oncology, said that before starting phase II, more work must be done to determine which peptide to use and how best to have the body absorb it. These, he said, are the primary obstacles to beginning the second trial phase.
"We are still gaining knowledge," he said. "We are not close to starting phase II." He noted that these kind of delays are common.
Although implementation of phase II is not yet viable, Morse gave a rough estimate of the phase's logistics: Twenty patients with advanced breast cancer would receive four doses of the vaccine every three weeks. Booster doses would be given to patients in whom the vaccine elicits a response; patients showing no response would drop out of the study.
Morse stressed, however, that this is just a prediction, and the actual trial could be different.
The segment of Her-2/neu protein used in the vaccine is made by Corixa, a Seattle-based firm. Since Corixa owns the peptide, all research done with it at the Medical Center must have the company's consent.
According to Morse, the Medical Center approached Corixa about doing the project. The company also supplies the Medical Center with some research funding, Although Morse said they are still negotiating, he stressed that any discussions between the University and Corixa are standard, and that the delays in the research have to do with science, not law.
Gillis said he had no knowledge of any legal difficulties.
"We own the intellectual property associated with the peptide," he said, adding that Corixa has a "research collaboration" with the University.
How the two parties will split the royalties if the treatment proves successful is as yet uncertain. Currently, medical centers at three universities-Duke, the University of Washington and the University of Texas-are testing different aspects of the Corixa-owned peptides.
Morse is also involved in phase II trials of a cancer vaccine that uses carcino embryonic antigen. Data for that trial has not yet been finalized. Furthermore, along with several other universities, Morse is also conducting a phase III trial of theratope, made by the company Biomira.
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