BEVERLY, MA--(Marketwired - Jan 5, 2015) - Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology and antimicrobial applications, is pleased to release additional statistics from the Company's recent, successfully completed Phase 2b trial of Brilacidin, Cellceutix's lead drug in a new class of antibiotics called defensin-mimetics, for Acute Bacterial Skin and Skin Structure Infections (ABSSSI).

On October 23rd 2014, Cellceutix announced positive top-line results for the randomized double-blind study comparing three dosing regimens of Brilacidin to daptomycin for the treatment of ABSSSI. The FDA-defined primary endpoint of at least 20% reduction in area of the ABSSSI lesion, relative to baseline, was achieved in all study populations at 48-72 hours, for each of the three Brilacidin dosing regimens and the active comparator, daptomycin. 

In treated patients assessed at 48-72 hours, 47/51 (92.2%), 46/48 (95.8%), 51/52 (98.1%), and 45/48 (93.8%) achieved clinical success in the Brilacidin 0.6 mg/kg single-dose group, Brilacidin 0.8 mg/kg single-dose group, Brilacidin 1.2 mg/kg 3-day group, and daptomycin 7-day group, respectively. 

The corresponding 95% confidence intervals around the clinical success rates were 85-100%, 90-100%, 94-100%, and 87-100%, respectively. It is important to note that this Phase 2b study was not powered for statistical comparisons. Nevertheless, because the 95% confidence intervals overlap, these clinical success rates are considered similar. Regulators prefer the use of 95% confidence intervals, rather than p-values, when comparing efficacy rates in clinical trials, as they can provide more information than p-values. A much larger study -- such as the kind done in phase 3 -- would have the power to make statistical comparisons.

On December 22nd 2014, Cellceutix also reported positive results in the Microbiological Intent-to-Treat (MITT) population. This is an important population that includes patients with baseline cultures positive for common ABSSSI pathogens, such as Staphylococcus aureus, including Methicillin-Resistant Staphylococcus aureus (MRSA). In this population, Clinical Success rates at 48-72 hours were again very high (above 90% across all treatment groups) and again very similar (with overlapping 95% confidence intervals).

"These results are outstanding across all dosing regimens," commented Leo Ehrlich, Chief Executive Officer at Cellceutix. "The Phase 2 data showing a one-time dose of Brilacidin achieving statistically comparable results to a seven-day dosing regimen for the current gold standard treatment for ABSSSI is fantastic and reason for great optimism going forward."

Additional updates on Brilacidin and other drugs in the Cellceutix pipeline will be given at the Biotech Showcase 2015 conference being held at Parc 55 Wyndham San Francisco (Union Square) in San Francisco, CA on January 12-14, 2015. Cellceutix will be presenting at the conference on Monday, January 12 at 2:00 PM PT in Room Powell.

About Cellceutix:

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 antimicrobial 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 will soon begin 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 has recently completed a Phase 1 clinical trial and is being readied for a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's key antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Top-line data has shown a single dose of Brilacidin to deliver statistically comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy 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

Forward-Looking Statements

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.

Contact Information:

Cellceutix Corporation
Leo Ehrlich