2005 Achievement in Clinical Research
Mark S. Kaminski, M.D.
It is the dream of most physician-scientists pursuing translational research to spearhead the development of a novel therapeutic agent from early pre-clinical or clinical testing to established medical practice. When Dr. Mark Kaminski joined the University of Michigan in 1985, he had a vision of developing immunotherapies, including antibody therapies, to treat lymphomas. Although this had been a hope of a number of investigators, at that time the development of a successful antibody-mediated therapy had not been demonstrated.
On June 30, 2003 , this dream came true for Dr. Kaminski when the Food and Drug Administration (FDA) approved the anti-cancer agent, Bexxar, for the treatment of patients with relapsed/refractory low-grade and aggressive transformed low-grade non-Hodgkin’s lymphoma (NHL), an incurable malignancy affecting over 20,000 Americans each year.
The FDA approval was the culmination of nearly 13 years of single-minded effort on the part of Dr. Kaminski, his close collaborator, Dr. Richard Wahl (formerly of U-M and now Chief of Nuclear Medicine at Johns Hopkins University), and colleagues at Michigan and cooperating medical centers. Later that year, Medicare approved payment for Bexxar therapy for Medicare-eligible patients; a significant proportion of NLH patients are in this age group.
The development of Bexxar was also a dream come true for the many patients who can take advantage of this novel treatment without the burden of conventional chemotherapy.
However, the birth of Bexxar did not end there. Perhaps even more exciting are Dr. Kaminski’s recently published results in the New England Journal of Medicine using Bexxar as a successful first-line treatment for patients who have not been treated with chemotherapy for their illness. In this study, 75 percent of patients achieved a complete remission, 75 percent of whom have remained in remission for over five years.
As a colleague notes, “Mark Kaminski has carefully developed the radioimmunotherapy to work in patients. He chose the perfect target in lymphoma patients because these patients have known antigens on the surface of their cells, which allows exploitation of this technology, and because these cells are known to be very radiosensitive compared to other neoplastic cells.” The research concludes, “Mark has clearly been the central driving force in these studies. His personality and his character make him a leader.”
Most impressive is the way Dr. Kaminski structured the research. Careful in doing dose escalation studies, he then asked the important questions with respect to selected target subpopulations to demonstrate proof of principle. Throughout the 1990s, he spearheaded pivotal clinical trials that demonstrated the feasibility and efficacy of the treatment modality. He defined the protocol that is now in clinical use, including a two-step process that first determines dosimetry and then delivers individually tailored, maximally tolerated doses of the radio-labeled antibody to avoid the complications of hematopoietic aplasia.
Dr. Kaminski’s efforts ensured the University of Michigan a leadership role in several multi-center trials that laid the foundation for FDA approval.
As one colleague says, “It is my opinion that few physician-scientists actually change a treatment paradigm for patients. Dr. Kaminski has clearly changed the treatment paradigm for patients with follicular lymphoma by working over the past 20 years to develop a novel targeted therapy. He also changed the outcome of these patients.”
Since 1987, Dr. Kaminski has been Co-director of the Leukemia/Lymphoma Program at U-M Comprehensive Cancer Center . As a leader of this program, he has helped to develop a strong reputation for the treatment of this disease. Dr. Kaminski and the Cancer Center program receive referrals not only from this region but also from around the country and around the world.
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