Cellceutix Submits Investigational New Drug Application (IND) for Clinical Trial of New Anti-Psoriasis Drug, Enrollment Underway in Phase 2b Clinical Trials of Brilacidin
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.
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol “CTIX”. Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology and antibiotic applications. Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix’s anti-cancer drug Kevetrin is currently in a Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations. Cellceutix is planning a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention and treatment of Oral Mucositis. Brilacidin-OM, a defensin mimetic compound, has shown in the laboratory to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix’s anti-psoriasis drug Prurisol is being readied for clinical trials at sites in the U.S. and Europe. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix’s key antibiotic, Brilacidin, is set to begin a Phase 2b trial in February 2014 for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Brilacidin has the potential to be a single-dose therapy or a dosing regimen that is shorter than currently marketed antibiotics for multi-drug resistant bacteria (Superbugs). Cellceutix has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. More information is available on the Cellceutix web site at www.cellceutix.com
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause Cellceutix’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.