Cellceutix Corporation (OTCBB: CTIX) filed a pre-IND submission with the FDA for Prurisol (also termed KM-133), a drug in development for treatment of psoriasis. The company is seeking guidance to attain approval for a section 505(b)(2) designation for Prurisol, allowing clinical trials to begin in advanced stages. "Prurisol is an ester of a FDA-approved drug that is used for different indications today," explained Dr. Krishna Menon, Chief Scientific Officer at Cellceutix, in a statement. Under 505(b)(2) guidelines, an NDA can be submitted for a novel drug with a sponsor forgoing a portion of clinical trials and without a "right of reference" from the original drug maker. FDA has already evaluated safety and tolerability of the active ingredient, so "We are hopeful that it will meet the requirements to advance immediately to Phase 2/3 clinical trials, saving considerable time and money," Dr. Menon added. The company is also investigating eligibility of the compound for Fast Track review.Next Story
Cellceutix Files pre-IND Submission for Prurisol for Psoriasis
Monday, March 12, 2012 | FDA Approval/Clearance
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