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PROCYTE’s IAMIN WOUND HEALING GEL WILL ENTER PHASE III

Executive Summary

PROCYTE's IAMIN WOUND HEALING GEL WILL ENTER PHASE III later this year for diabetic ulcers, the company said in a March 13 preliminary prospectus for a secondary offering. Iamin, a peptide- copper compound-based gel, has been tested on more than 100 patients with diabetic ulcers and is in the final stages of Phase II trials. "Based on the progress of these studies, the company expects to commence a large-scale Phase III clinical trial later in 1992 at approximately 30 sites to further evaluate Iamin for treatment of diabetic ulcers," the prospectus states. The trials to date have shown stimulation of tissue repair and accelerated healing of chronic dermal wounds, according to ProCyte. Iamin is a revised formulation of a cream compound that ProCyte had been testing for treat-ment of venous stasis ulcers in 1990 under the direction of Schering-Plough, with whom the company entered a licensing agreement in May 1989. After patients in that Phase II study experienced irritation at the wound site, Schering- Plough expressed disappointment with the lack of efficacy. As a result, the two companies mutually terminated the agreement in April 1991. In later Iamin studies, ProCyte replaced the cream base with a "non-irritating gel formulation, increased dosage levels and also administered Iamin by injection," the prospectus says. "In each study, healing effects were observed with none of the irritation noted in the Schering study." ProCyte also anticipates studying Iamin for stasis ulcers, decubitis ulcers (bed sores) and burns in topical formulations and for surgical wounds in an systemic formula. In addition to Iamin, ProCyte plans to expand clinical studies for Iamin-IB, which is currently in Phase I/II for inflammatory bowel disease; start a U.S. Phase II trial of its hair growth product Tricomin; and begin a Phase I/II study of Cytril for treating peptic ulcers. ProCyte, which has applied for patent protection for all new peptide-copper compounds, believes that the biological properties of peptide-copper compounds may prove to be effective in treating bone disease and injury as well as protecting arteries, blood vessels and organs from reperfusion injury. ProCyte believes its proprietary compounds act as "chemoattractants of cells that express a number of natural growth factors" and stimulate "formation of granulation tissue," thereby accelerating the "interrelated activities associated with tissue repair," the prospectus states. ProCyte was established in 1986 and went public on Nov. 16, 1989, netting $9.3 mil. Since the termination of Schering-Plough's support, ProCyte has had no contract research revenues, previously the main source of its funds. As of Feb. 29, the start-up had cash and cash equivalents of about $5 mil. The proposed secondary public offering is for 2 mil. shares of common stock at an estimated price of $10 per share, which the company hopes will net $18.8 mil. A successful offering would fund R&D for another two years, as well as finance a $2-$3 mil. commercial-scale manufacturing facility and pay for related equipment. ProCyte anticipates going to the public funding well again before Iamin reaches the commercialization stage, the prospectus notes. Oppenheimer & Co. and William Blair are underwriting the offering. ProCyte is based in Kirkland, Wash. and had 38 full-time employees as of March 9. The company leases 21,000 square feet of lab and office space. Key personnel include John Ashley, the company's president and CEO, and VP-Research Gordon Duncan, PhD, who was formerly VP-research administration with Upjohn. Ashley, who has been with ProCyte since January 1987, was president and chief operating officer of Genetic Systems from 1984-86 and previously worked for Beckman Instruments. Duncan joined the start-up in April 1991 after more than 20 years with Upjohn.

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