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FDA Approves Initiation of Dimericine® Study
in Renal Transplant Patients

FREEPORT, N.Y., November 10, 2003 -- The FDA has approved the start of a Phase II clinical study of the DNA repair liposome Dimericine in renal transplant patients. The study is sponsored by the Division of Cancer Prevention of the National Cancer Institute and the study will be led by Craig Elmets, M.D. at the University of Alabama, Birmingham. Transplant patients are at greatly increased risk of skin cancer due to the immunosuppressive drugs they take as part of the transplant therapy. AGI Dermatics will be supplying the drug for the study.

The NCI is investigating whether Dimericine will lower the incidence of skin cancer in these patients over a one-year period of use. UAB is one of the largest transplant centers in the country. Other medical research universities with large transplant programs participating in the study are the University of Pennsylvania and the University of Michigan.

For more information about the study on renal transplant patients, visit the National Cancer Institute's web site.