Cellceutix Corporation, a clinical stage biopharmaceutical company, has submitted the application to the Institutional Review Board (IRB) responsible for the planned clinical study of its psoriasis drug Prurisol.
The trial is a short crossover study being conducted at the request of the US Food and Drug Administration (FDA) with the purpose of demonstrating that Prurisol, an ester of abacavir, converts into abacavir in humans, just as it did in animal models. Once IRB approval is received, Cellceutix will immediately file an Investigational New Drug (IND) Application with the FDA. The trial is expected to take approximately one and a half months to complete, at which time the Company will move forward with initiation of a larger phase II/III trial under the guidance from the FDA that a 505(b)(2) designation is an appropriate developmental pathway for Prurisol.
“Submitting the application to the IRB to begin clinical trials of Prurisol is a fantastic way to begin the year,” commented Leo Ehrlich, chief executive officer at Cellceutix. “We are excited to kick-off 2014 with Prurisol moving into human studies, our novel antibiotic Brilacidin commencing a phase IIb trial in January, and Kevetrin, our flagship anti-cancer drug, reaching the latter stages of its phase I trial. These trials represent our unwavering commitment to build shareholder value and bring new drugs to market spanning several areas of great unmet medical need.”
Cellceutix will be providing a comprehensive update on all of its pipeline developments at the Biotech Showcase 2014 conference being held in San Francisco, California January 13-15.
Cellceutix is developing innovative therapies in oncology, dermatology and antibiotic applications.