BEVERLY, MA -- (Marketwired) -- 03/21/14 -- Cellceutix Corporation (OTCQB: CTIX) (the "Company"), 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.
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 in a Phase 2b trial 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.