New York, April 1, 1999—The Juvenile Diabetes Foundation International (JDF) and Sertoli Technologies (STI) have formed a two-year research collaboration aimed at moving STI’s patented cellular therapy for Type 1, or insulin-dependent, diabetes rapidly toward preclinical and clinical studies.

    The research program will develop grafts composed of Sertoli cells and pancreatic islets for use in transplantation therapy to cure diabetes. Sertoli cells, which are obtained from the mammalian testis, produce an array of factors that nourish developing sperm and protect them from attack by the immune system.

    Pancreatic islet cells secrete insulin in response to blood sugar levels. A graft consisting of Sertoli cells and islets could simultaneously provide insulin-independence and prevent immune rejection.

    STI’s initial development of the therapy has shown long-term survival of Sertoli cell/islet grafts in both lower and higher animals. The new STI–JDF collaboration will develop Sertoli cell/islet allografts—with use of tissue from the same species—to cure diabetes in animal and preclinical models.

    If successful, this will expedite the beginning of clinical trials using human Sertoli cell/islet grafts in patients with Type 1 diabetes. STI and JDF will fund the program jointly and may extend and develop their collaboration in the future.

    In the past decade, some cases have been reported in which transplanted human islets have rendered diabetic recipients insulin-independent for varying periods. In all of these cases, the patients required chronic immunosuppression to prevent destruction of the islets by their immune system.

    STI’s novel cellular therapy is attractive because it has the potential to allow islet transplantation into people with Type 1, or juvenile, diabetes without lifelong systemic immunosuppression.

    “Our review committee noted the novel and innovative approach taken by STI, and we look forward to working with STI to find a cure for diabetes—a disease that kills one American every three minutes,” said Dr. Robert Goldstein, vice president of research at JDF.

    In 1998 alone, JDF awarded more than 200 research grants and over 110 fellowship and career develop awards to scientists in 17 countries throughout the world.

    STI is developing breakthrough technology that could make cellular therapy a commercial reality. The STI technology could be the basis for several potential implant products that can survive without the need for lifelong antirejection drugs.

    STI and JDF will implement their collaborative program through two teams of researchers at the Carolinas Medical Center (CMC) in Charlotte, N.C. and the University of Alberta (U of A) in Edmonton, Canada. Paul F. Gores, M.D., director of pancreas/islet transplantation at CMC Craig Halberstadt, Ph.D., director of tissue engineering at CMC, and Ray V. Rajotte, Ph.D., director of the U of A Surgical-Medical Research Institute and Gregory S. Korbutt, Ph.D., assistant professor of surgery, head STI’s multidisciplinary research team.

    These teams have been working with STI over the past several years to extend the early results of Dr. Helena Selawry, formerly at the University of Tennessee Medical Center and the Veterans Affairs Medical Center in Memphis, who first discovered the immunoregulating properties of Sertoli cells.

    “Our financial and scientific collaboration with JDF will build on our promising results from the laboratories at CMC and the U of A,” said STI President Shaun Kirkpatrick. “The recognition and support from this international diabetes organization will significantly improve the likelihood that our product will have an impact on diabetes.”

[Contact: Julie Kimbrough, JDF Manager of Media Relations, (212) 479-7536, or Jan McCoy Hutchinson, Sertoli Technologies, (520) 748-4458]