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CHEMEX WRAPPING UP PHASE II TRIALS OF C205 IN BASAL CELL CARCINOMA

Executive Summary

CHEMEX WRAPPING UP PHASE II TRIALS OF C205 IN BASAL CELL CARCINOMA and actinic keratosis, Chemex President Edward Niess, MD, reported at an Alex Brown & Sons health care seminar in Baltimore on June 11. "We filed an IND in 1982 with a considerable data base and started clinical evaluation," Niess said. "We have studied well over 160 patients, and we do not need casts of thousands in the dermatological area for development of new drugs that have dramatic effects." In addition to Chemex' studies in the U.S., Zenyaku Kogyo is conducting clinical studies of the topical agent in Japan. Once the Phase II study data for C205 is compiled and analyzed, Neiss said that Chemex will approach those drug companies that have expressed interest in licensing the compound. "We intend to have a data base complete without holes in it by the end of this year," Neiss said. "We're doing a lot of biochemistry, toxicology and clinical evaluation and we intend to present our data base to a number of multi-national pharmaceutical companies that have inquired about this data as opportunities for them to in-license, co-develop and market" the drug. Neiss said Chemex intends to sign an agreement with an established pharmaceutical company "by the end of the year and work together in Phase III with such a company, who subsequently will market on our behalf." Neiss predicted that the market for C205 in the U.S. could be $20 mil. annually and that the company "anticipates $100 mil. sales in the first five years." To date, clinical results of the C205 studies have been very promising, Neiss indicated. He said the drug "causes total remision of basal cell carcinoma" and "can cause remission of actinic keratosis in one, two, or three doses." Actinic keratosis, Neiss explained, is "a sun-induced lesion that goes on to basal cell carcinoma or squamous cell carcinoma and, therefore, is of considerable significance." He noted that the incidence of such lesions is "increasing with time . . . because we have been a sunloving society." In addition to actinic keratosis, Chemex has "significant experience in looking at evaluating cutaneous ulcers of the skin in patients, psoriasis, and basal cell carcinoma -- each of which we will address in sequence once we bring the product to the market for actinc keratosis," Neiss said. He noted that FDA has classified C205 as a 1-A drug (new chemical entity representing a significant therapeutic advance). Chemex is a Denver, Colorado-based end-stage development company that focuses on using new technologies to diagnose and treat skin diseases in humans and animals. In addition to research in the Rx area, Chemex is also developing products for the OTC and poersonal care markets, Neiss said. The company plans to launch a system of monoclonal antibody-based diagnostic kits for the dermatologist's office sometime next year, he noted. Chemex recently signed an agreement covering veterinary uses of C205 with the Belgian firm, Solvay. Also, Neiss pointed out that Chemex recently completed a private placement worth approximately $11 mil. to help fund R&D.
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