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Executive Summary

APS MELANOSPONGE MELANIN-BASED Rx SUNSCREEN is expected to enter clinicals in early 1989, according to Advanced Polymer Systems. The firm expects to file an IND for the product in the first quarter of next year. The broad-spectrum sunscreen incorporates biosynthetic melanin into APS' Melanosponge polymer-based microsphere delivery system to form a melanin barrier on the skin. Preclinical testing, according to APS, indicates that the proprietary sun protectant "mimics" the skin's natural protective ability against UVA, UVB and UVC ultraviolet rays. APS is projecting that NDA approval could come within 12-18 months after the IND is filed. The firm hopes for a quick review by the agency since the sunscreen does not penetrate the skin. APS anticipates that FDA will require only short-term toxicity testing, according to a spokesperson. The sunscreen forms a waterproof shield on the skin's surface that remains until washed off with soap and water. The microspheres are cationic polymers and so remain on the skin, which has a negative charge. The sunscreen also imparts a "distinctive bronzing effect," because the microspheres are designed to hold the melanin in place without releasing it, APS Director of Skin Biology Miles Chedekel, PhD, said. The Melanosponge system works by duplicating the body's natural UV ray defense in which melanin granules, called melanosomes, exert a "scattering effect" on UV rays, according Chedekel. A melanin expert and skin biologist, Chedekel joined the company in May from Johns Hopkins University to scale up the project. The bioengineered melanin is being supplied by Vacaville, Calif.-based Biosource Genetics. With Biosource's Geneware plant genetic engineering techniques, the company can, for the first time, supply unlimited quantities of biosynthetic melanin, according to APS. Biosource is currently developing a range of melanin shade gradations that would be cosmetically acceptable for a variety of skin tones. The melanin sun protectant is the first in a proposed line of proprietary dermatiologic formulations from Advanced Polymer Systems. To help bring the product to market, the company recently formed a dermatological advisory committee. The group is composed of Albert Kligman, MD, Lorraine Kligman, PhD, and James Leyden, MD, of the University of Pennsylvania; University of Iowa's John Strauss, MD; Associate Director for the Temple School of Medicine Center for Photobiology, Donald Forbes, PhD; and Howard Maibach, MD, and John Epstein, MD, of the University of California at San Francisco. Some of the pre-clinical testing is being conducted by committee members; others are serving in an advisory capacity, APS explained.

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