ProCyte Corp. said it has completed patient enrollment in the first oftwo pivotal Phase III studies of Iamin for the treatment of nonhealingplantar ulcers in people with diabetes. Patients still are being enrolledin the second Phase III study.Patients in the first study will receive treatment for 16 weeks followedby two weeks of evaluation, with end points being the rate of closure,reduction of infection and full closure. Those in the second study willreceive eight weeks of treatment with Iamin, a tripeptide coppercomplex, followed by six weeks of evaluation.The Kirkland, Wash., company plans to treat about 500 people withdiabetes who have chronic wounds on the bottom of their feet. Patientswill be assigned to three treatment groups: placebo, .5 percent or 2percent topical gel."We found, retrospectively (from the Phase II study), that the drugworks very well in the treatment of all plantar ulcers, (but) the drugworked considerably better in large plantar ulcers," Karen Hedine,ProCyte's vice president, business development, told BioWorld."Another thing we found out is we had a 5-to-1 reduction in the rate ofinfection" with the drug group vs. placebo. "We think the drug is avery strong granulator."She said if enrollment in the second study goes as planned, thecombined study should be finished by the end of September, and a newdrug application filed in early 1995. _ Jim Shrine
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