Cellceutix Corporation, a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, announces today that the U.S. Food and Drug Administration's ("FDA") 30-day waiting period pertaining to the Company's Investigational New Drug Application ("IND") for Prurisol has now passed. Cellceutix is moving towards the commencement of clinical trials of Prurisol as a new drug candidate for the treatment of psoriasis.
"This is another significant moment for our Company as we bring our third compound into clinical trials," commented Leo Ehrlich, Chief Executive Officer at Cellceutix. "A steady stream of developments has led to a great start to 2014 for our Company. We initiated a multi-center Phase 2b trial of our novel antibiotic Brilacidin. The Phase 1 trial of our novel anti-cancer compound Kevetrin is in the seventh cohort and now Prurisol is set to enter human trials, positioning us with three clinical drug candidates targeting three different areas of unmet medical need."
"I am also excited about the laboratory research that is being conducted on Brilacidin for a wide range of indications," added Mr. Ehrlich. "We are nearing completion of IND-enabling studies of Brilacidin-OM for oral mucositis. Other pre-clinical studies of Brilacidin are ongoing for otitis and ophthalmic infections. Separately, in our recent acquisition of assets we acquired a library of compounds that have shown promise for Gram-negative bacterial infections. These compounds have been sent to a university laboratory in Texas for further testing. We are actively developing other acquired compounds for anti-fungal treatments. In short, while we are very pleased with the clinical development to date, we feel that there are many other areas of tremendous opportunity for our pipeline and intend to relentlessly research them to define future clinical trials."
Cellceutix is developing Prurisol under FDA guidance that a 505(b)(2) designation is an appropriate development pathway. The initial clinical research will be a brief Bioequivalence crossover study expected to last approximately 45 days with the primary endpoint of demonstration that Prurisol converts to abacavir in humans, as it has been shown to do in animal models. Upon successful completion of the crossover trial, the Company will initiate a larger Phase 2/3 clinical trial under a 505(b)(2) designation, which would permit Prurisol to move to advanced trials because the active moiety of Prurisol is that of a drug already approved by the FDA.
Cellceutix management previously submitted to the FDA an application for an Orphan Drug designation for Brilacidin-OM for the prevention of oral mucositis in head and neck cancer patients. After reviewing the extensive data supplied with the application, the FDA advised the Company that the data would indicate that Brilacidin-OM could treat a patient population that is actually too large for an Orphan Drug designation. Although the Company is glad that the market is potentially much larger than initially thought, meaning that Brilacidin-OM would be beneficial to so many more people suffering from this terrible disease, Cellceutix management is evaluating all scenarios. The Company may narrow the focus of the application and continue the dialogue with the FDA going forward or pursue the larger market. The Company believes either option presents the potential to capture significant market share with the introduction of a new therapy for oral mucositis.