Phase 1 Study Demonstrates Prurisol Eligible for FDA 505(b)(2) Regulatory Path
BEVERLY, MA–(Marketwired – Dec 10, 2014) – Cellceutix Corporation (OTCQB: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, and antimicrobial applications, is pleased to announce that the US Food and Drug Administration (FDA) has agreed that Cellceutix may begin a Phase 2 study of Prurisol (abacavir acetate), a potential chronic oral therapy for the treatment of placque psoriasis. Cellceutix conducted a Phase 1 study which demonstrated that the bioavailability of the active component of Prurisol (abacavir) was the same or lower than that of the marketed drug Ziagen® (abacavir sulfate). FDA noted at the end-of-Phase 1 meeting on December 8, 2014 that, pending the full review of the Phase 1 data, long-term safety data for Prurisol in the treatment of psoriasis would not be required.
Prurisol will be eligible for the 505(b)(2) drug approval pathway for the treatment of psoriasis. A potential application to market Prurisol will contain safety and efficacy data from studies conducted by Cellceutix, but at least some of the information required for approval may come from studies not conducted by Cellceutix. In this case, the long term safety data for Ziagen, marketed for over 15 years in the US, will be referenced.
“We are excited to enter the next phase of clinical development for Prurisol,” stated Leo Ehrlich, Chief Executive Officer of Cellceutix. “There is a need for additional non-biologic treatments for chronic psoriasis and we think Prurisol has great potential based on our earlier results in an animal model of psoriasis. We look forward to the many important events happening this month at Cellceutix.”