BEVERLY, MA–(Marketwired – Oct 2, 2013) – Cellceutix Corporation (OTCQB: CTIX) (the “Company”), a clinical stage biopharmaceutical company focused on discovering, developing and commercializing drugs to treat unmet medical conditions, today announces that the bridging study on Prurisol, the Company’s anti-psoriasis drug candidate, has been completed by an outside vendor and that Cellceutix has received the report. The study documents the ester bond in Prurisol™ (a prodrug) is readily cleaved and converted as expected. This study was requested by the Food and Drug Administration to be included in the Investigational New Drug (“IND”) application with the FDA under a 505(b)(2) designation. This completes the lab studies needed for filing an IND for Prurisol.
Cellceutix is reviewing clinical sites in the United States and internationally to initiate a Phase 2/3 trial as Dr. Reddy’s Laboratories Ltd. finalizes the Chemistry, Manufacturing, and Controls section (“CMC”) of the IND. The CMC is expected by the end of the month and the IND filing shortly thereafter. Dr. Reddy’s has already completed the manufacturing and stability studies of Prurisol for a multi-center clinical trial.
“I wish to thank Dr. Reddy’s Laboratories for their assistance in this study. The results from the final study for the FDA submission were exactly as expected. We are very eager to move Prurisol into a large-scale human trial, where we are optimistic that the drug will validate earlier research and prove itself as a new, potent therapeutic for psoriasis,” commented Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. ”Meanwhile, we are moving quickly with the regulatory work with our new antibiotic, Brilacidin™, to begin a Phase 2b clinical trial for ABSSSI and phase 2 trial for oral mucositis. In recent weeks, we have added to our clinical support staff in preparation for all of the trials in addition to the ongoing Phase 1 trial of our anti-cancer drug Kevetrin™. We have been advised that the Safety Review Committee is meeting early next week to determine the dosing levels of Kevetrin for the sixth cohort in the trial at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center. We anticipate that the dosing will be above 100 mg/m2, a level that we have considered an important dose since the trial began. This is an exciting time as there are many, many positive developments happening concurrently as we align to conduct multiple clinical trials with our extremely promising compounds.”