BEVERLY, MA—Dec 9, 2013 – Cellceutix Corporation (OTCQB:CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, today updates shareholders on recent developments and future plans. A comprehensive update will be provided to shareholders in mid January 2014.
Prurisol: Cellceutix has corresponded with the U.S. Food and Drug Administration (FDA) in preparation for clinical trials of Prurisol as a new oral drug candidate for psoriasis. The FDA has advised the Company that a 505(b)(2) designation is an appropriate pathway for development of Prurisol. Because Prurisol is an ester of abacavir, the FDA has requested that Cellceutix conduct a short Phase 1 crossover study to demonstrate that Prurisol converts into abacavir in humans before initiating a larger-scale Phase 2/3 trial. Cellceutix is selecting the site for this study and the protocol will be submitted to the site’s Institutional Review Board (IRB) for approval. Cellceutix plans to accomplish this by the end of this month. It is anticipated that the trial will take one month to complete.
Brilacidin for Acute Bacterial Skin and Skin Structure Infections (ABSSSI): The Company has selected clinical sites for the phase 2b trial and is finalizing requisite documentation for submission to the respective Institutional Review Boards by the end of this month. The Investigational New Drug application for Brilacidin for ABSSSI is active with the U.S. Food and Drug Administration (FDA). After IRB approval, the Company may immediately commence with its Phase 2b clinical trial, which is planned for January 2014.
Kevetrin: The sixth cohort has completed dosing in the Phase 1 clinical trial of the Company’s anti-cancer drug Kevetrin being hosted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center. The safety committee is scheduled to meet in mid-December to define the increased dose for the seventh cohort. Maximum tolerated dose of Kevetrin has not yet been reached. Further, Cellceutix has filed an amendment to the trial protocol with the FDA to limit the dosing duration of Kevetrin to six hours. Cellceutix filed the amendment to keep the dosing time frame within a reasonable number of hours as the dosing level increases as the trial progresses.
In addition to the above listed projects, Cellceutix staff is conducting research with Brilacidin for oral mucositis, ophthalmic diseases and otitis as well as other projects previously announced.
Leo Ehrlich, Chief Executive Officer, of Cellceutix commented, “Since last month’s Elsevier conference, we have entered into two confidentiality agreements with multi-billion dollar companies interested in our pipeline. We have a lot to accomplish over the coming weeks, which should set Cellceutix up for an exciting new year. We will provide shareholders with a more comprehensive update during the JP Morgan conference in January 2014.”