BEVERLY, MA—February 18, 2014 – Cellceutix Corporation (OTCQB: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, announces today that the Company has submitted an Investigational New Drug Application (“IND”) to the U.S. Food and Drug Administration (“FDA”) for the clinical development of Prurisol as a potential new treatment for psoriasis.
Per regulatory protocol, the FDA has 30 days to review the IND. If the FDA in that time frame raises no questions, the first clinical trial of Prurisol is allowed to begin.
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 Phase 1 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 plans to 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.
Additionally, Cellceutix is pleased to announce that recruitment is underway in the Phase 2b clinical trial of Brilacidin for Acute Bacterial Skin and Skin Structure Infections (“ABSSSI”). Brilacidin is the Company’s lead compound in a novel class of synthetic immunomodulatory antimicrobials known as defensin-mimetics. The randomized, double-blind Phase 2b trial is being conducted at multiple centers in the U.S. to evaluate the safety and efficacy of Brilacidin for ABSSSI utilizing three different dosing regimens of Brilacidin as compared to daptomycin.
“2014 has begun with our Company meeting some very significant milestones in the first two months,” comments Leo Ehrlich, Chief Executive Officer at Cellceutix. “Our team has moved with precision to have Brilacidin enrolling patients in a mid/late-stage clinical trial only five months after we acquired it. Now the IND for Prurisol is filed, positioning us to initiate a third clinical trial in an area of great unmet medical need.”
With respect to upcoming research, Cellceutix management has recently returned from meetings with potential formulation developers regarding Brilacidin for ophthalmic and otitis indications. The Company plans to aggressively pursue these conditions as they represent very large markets with inadequate antibiotics, offering an enormous opportunity for our shareholders. This is a program with its own unique set of challenges but these developers have outlined a comprehensive plan how to achieve the criteria we set up for the formulation. Cellceutix anticipates signing a formulation agreement in the coming weeks.