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CHEMEX TOPICAL AMLEXANOX PHASE 1/11 TRIALS

Executive Summary

CHEMEX TOPICAL AMLEXANOX PHASE 1/11 TRIALS are expected to begin sometime during the first quarter of this year, the Denver, Colo.-based R&D firm said. In a January 11 press release, Chemex announced a licensing agreement with Takeda covering U.S. rights to develop and market the anti-allergy agent amlexanox (CHX 3673), and CHX 3988, a platelet activating factor antagonist, for dermatologic uses. Takeda already markets an oral version of amlexanox in Japan for the treatment of bronchial asthma. Chemex said it will investigate topical uses of amlexanox for the treatment of psoriasis, eczema, and hives. An IND for amlexanox studies in the U.S. was filed in late December. Chemex describes CHX 3988 as a "potent antagonist of platelet activating factor." A Chemex spokesperson said that Phase I/II studies with CHX 3988 have already begun in the U.S. While Takeda is investigating uses involving I.V. administration of the drug, Chemex is looking at topical uses. "Because of the biochemical similarities between the basis of [the internal diseases under study at Takeda] and certain skin diseases, Chemex will investigate topical formulations of CHX 3988 for treatment of atopic and allergic dermatitis, psoriasis and certain immune diseases of the skin." Takeda's "large amount of data from human and animal studies" on the two drugs will allow Chemex to shorten the development period to registration for its topical formulations, Chemex President Edward Neiss, MD, predicted. "With this agreement, we can shorten the normal research and development cycle for new dermatology products by at least two years," he said. "The agreement which we are announcing today is part of our strategy of shortening the development time needed to bring new skin therapies to the marketplace, Neiss commented. "This complements other products, with shorter development times, which we will introduce to commerce in 1988 and 1989," he said. Chemex has been an active licensor of compounds for topical development in recent months. Last week, Chemex announced an agreement with Upjohn covering topical uses for Cytosar-U and Trobicin ("The Pink Sheet" Jan. 11, "In Brief"). In the fall, Chemex said it had signed a development agreement with Squibb covering several undisclosed compounds. ("The Pink Sheet" Sept. 28, T&G 4). The company also has two concurrent five-year agreements with Yale, announced in June 1987, that give Chemex first refusal and licensing rights for drugs that Yale develops under Chemex sponsorship. Chemex' lead drug CHX 2053, or C205, is in Phase II/III studies and Chemex hopes to file an NDA for it by the end of this year. Chemex also filed IND's for three CHX 2053 derivatives in 1987. CHX 2053 is under study for use in treating basal cell carcinoma.
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