Procyte Corp. said Thursday that a small, initial study of Iamin-IBsolution for inflammatory bowel disease showed 60 percent ofevaluable patients had symptomatic improvement and, usingendoscopic evaluation, 80 percent showed significant reduction ininflammation of the bowel.The Phase I/II open-label study of the tripeptide copper complex wasconducted on 16 patients at the University of Washington. TheKirkland, Wash., company said the study showed an excellent safetyprofile for Iamin-IB in addition to the therapeutic benefit."These were patients who had been refractory, so to see someimprovement was very encouraging," Karen Hedine, Procyte's vicepresident, business development, told BioWorld. She said a pilot PhaseII study is being designed that probably will involve dose escalation,more patients, multicenters and a placebo control.Iamin also is being tested in nonhealing diabetic plantar ulcers. Fullenrollment of more than 500 patients has been completed for twopivotal Phase III studies, Hedine said. The treatment and observationphases are expected to be wrapped up in late September, and resultsshould be known by the end of the year, she said.Patients in the first study will receive treatment of the topical gel orplacebo for 16 weeks followed by two weeks of evaluation, with endpoints being the rate of closure, reduction of infection and full closure.Those in the second study will receive eight weeks of treatmentfollowed by six weeks of evaluation.Procyte hopes to start a Phase II study of Iamin in pressure ulcers laterthis year.Procyte (NASDAQ:PRCY) stock gained 38 cents per share Thursday,closing at $10.38. _ Jim Shrine
(c) 1997 American Health Consultants. All rights reserved.