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BEVERLY, Mass. — Cellceutix on Wednesday reported that the Food and Drug Administration granted a section 505(b) designation for its Prurisol treatment for psoriasis, which would allow the company to forgo early-stage trials and advance Prurisol into latter-stage clinical trials.
"It was a very productive meeting with the FDA, providing us with valuable advice about advancing Prurisol down the regulatory pathway," stated Cellceutix CEO Leo Ehrlich. "Now we will begin the preparatory work necessary for a phase-2 clinical trial application for Prurisol based upon the FDA guidance," he said.
"The recent activity of Steifel Labs, a GlaxoSmithKline company, spending approximately $350 million to acquire rights to skin treatment drugs still in development from Welichem Biotech and Basilea Pharmaceutica demonstrates how valuable and in high demand new dermatological drugs are right now," Ehrlich added. "This is a very exciting time for Cellceutix and its shareholders as we transition from pre-clinical to clinical with drugs that have incredible potential."
Cellceutix previously has disclosed images of mice treated with Prurisol demonstrating its effectiveness as compared with methotrexate, a standard care treatment for psoriasis today.