SOURCE: Cellceutix

Cellceutix

May 11, 2016 09:30 ET

Data From Phase 2 Trial of Prurisol for Psoriasis to Be Unblinded Next Week, Top-Line Results to Follow

BEVERLY, MA--(Marketwired - May 11, 2016) - Cellceutix Corporation (OTC: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that the clinical database for the Phase 2 clinical trial of Prurisol for the treatment of mild-to-moderate chronic plaque psoriasis is expected to be "unblinded" next week. Once the blind is removed, data from each of the four arms of the trial (one placebo arm, three oral dosing regimens of Prurisol) will be reviewed and analyzed to evaluate the safety and efficacy of Prurisol. Cellceutix expects to release top-line data from the study approximately one week after the blind is removed.

Separately in Cellceutix's dermatology pipeline, the Company last month reactivated a request for a Pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) to discuss initiating clinical research of Brilacidin, Cellceutix's lead defensin mimetic, for the treatment of the inflammatory skin condition hidradenitis suppurativa. Cellceutix previously filed the request, ultimately electing to hold off on clinical studies of Brilacidin for dermatological uses until several other clinical trials sponsored by the Company were completed or neared completion. Cellceutix anticipates the meeting to transpire in June 2016 and will be submitting a Briefing Book to the FDA on the planned trial one month prior to the meeting.

More on the Phase 2 trial of Prurisol can be found on Clinicaltrials.gov: https://clinicaltrials.gov/ct2/show/NCT02494479?term=cellceutix&rank=2

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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 multiple diseases. 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 concluded a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and Cellceutix is now preparing its FDA application for a Phase 2 ovarian cancer study. 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 in a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of Oral Mucositis in patients with head and neck cancer. Brilacidin-OM, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix's anti-psoriasis drug Prurisol concluded a Phase 2 trial, data is still blinded. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for certain 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.

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.

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