Ph III Trials With ProCyte Iamin Gel Near Completion

Copper-based drug specialist ProCyte Corp is set to complete Phase III testing on its lead product, Iamin Gel (PC1020; - glycine-L-hystidyl-L-lysine; copper complex), for the treatment of diabetes plantar wounds by the end of this month. The last patients will have come off the medication by this time, and a New Drug Application in the USA is on target for first-quarter 1995, according to Brian Melonakos, the company's vice president for marketing, speaking at the Medical Investment Northwest meeting in Seattle, Washington, on September 12.

Results of a Phase II diabetes ulcer study first reported in the third quarter of 1992 showed that treatment of large diabetic plantar ulcers with a 2% Iamin Gel led to a mean percentage closure of 67%, compared to -13% for patients who received vehicle. Other important outcomes in this study were that the time to healing was markedly reduced, as was the incidence of complicating infections (32% versus 6%). Importantly, Iamin's effects were seen over a range of ulcer sizes, and achieved a 30% closure rate amongst the large ulcer category, which are the most resistant to therapy.

Iamin Gel has been shown in animal models to initiate a cascade of events, which lead to angiogenesis, collagen secretion and glycoasaminoglycan synthesis at the wound site, all of which assist in the formation of the extracellular matrix and wound healing. In short, the agent delivers copper to wound sites and makes it available for several essential enzyme systems (eg superoxide dismutase and cytochrome C oxidase), which are involved in tissue repair maintenance and other biological functions, such as stimulating the recruitment at the wound site of important cell types (mainly monocytes, mast cells and fibroblasts), which are essential for the process of healing.