ARTICLE | Clinical News

Prurisol abacavir acetate: Phase I data

September 15, 2014 7:00 AM UTC

Cellceutix said oral Prurisol met the primary endpoint of bioequivalency to Ziagen abacavir sulfate in an open-label, crossover, U.S. Phase I trial in about 18 healthy volunteers. The company could not be reached for details, but said it plans to schedule a meeting with FDA to discuss a Phase II/III trial of Prurisol in patients with moderate to severe plaque psoriasis. Cellceutix is developing the compound under section 505(b)(2) pathway of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from scientific literature or from previously approved products (see BioCentury, June 18, 2012). ...