The global pharmaceutical company Novartis, based in Switzerland, is licensing research conducted at University of Louisville to help transplant patients better tolerate donated kidneys. Financial aspects of the agreement between Novartis and the Louisville biotechnology company Regenerex LLC, the original licensee and completed last month, were not disclosed. Regenerex is the company founded by Suzanne Ildstad, the Louisville faculty member who led the research.
The agreement provides Novartis with an exclusive global license to Regenerex’s facilitating cell therapy platform, as well as further collaboration between Novartis, Regenerx, and the university’s Institute for Cellular Therapeutics, where Ildstad serves as director.
With facilitating cell therapy, the kidney donor also provides blood-forming bone marrow stem cells that are enriched and processed to better help the recipient’s immune system accept the donor kidney. The recipient also undergoes radiation and chemotherapy to temporarily suppress his or her bone marrow, making room for the donated facilitating cells.
After the donated kidney is transplanted, the donor’s enriched stem cells are grafted into the recipient’s bone marrow, to create a greater tolerance in the recipient’s immune system for the donated tissue. That tolerance makes it possible for the recipient to decrease the need for anti-rejection drugs.
An early-stage clinical trial of the technique reported last year showed five of eight test recipients were able to reduce and finally end their taking of all immunosuppression drugs after one year. An intermediate-stage trial aiming to enroll 30 patients in Louisville and at Northwestern Memorial Hospital in Chicago is now recruiting participants.
Novartis’s interest in facilitating cell therapy extends beyond kidney transplants, with potential applications to its cell therapies for acute lymphoblastic and chronic lymphocytic leukemia, as well as expanding the benefits of umbilical cord blood stem cells. In addition, Regenerex is developing therapies for sickle cell disease, supported by Small Business Technology Transfer grants from National Institutes of Health.
Ildstad joined the Louisville faculty in 1998, under Kentucky’s Bucks for Brains program that aims to generate economic activity from university research. Under Bucks for Brains — officially known as the Research Challenge Trust Fund — state funds are matched by private donations. Since 1998, Kentucky’s legislature appropriated some $400 million to the program, with one-third of that amount allocated to University of Louisville.
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