SOURCE: Cellceutix

December 10, 2014 07:39 ET

Cellceutix: Prurisol™ for Psoriasis -- FDA Agrees That Phase 2 Study May Begin

Phase 1 Study Demonstrates Prurisol Eligible for FDA 505(b)(2) Regulatory Path

BEVERLY, MA--(Marketwired - Dec 10, 2014) - Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, and antimicrobial applications, is pleased to announce that the US Food and Drug Administration (FDA) has agreed that Cellceutix may begin a Phase 2 study of Prurisol (abacavir acetate), a potential chronic oral therapy for the treatment of placque psoriasis. Cellceutix conducted a Phase 1 study which demonstrated that the bioavailability of the active component of Prurisol (abacavir) was the same or lower than that of the marketed drug Ziagen® (abacavir sulfate). FDA noted at the end-of-Phase 1 meeting on December 8, 2014 that, pending the full review of the Phase 1 data, long-term safety data for Prurisol in the treatment of psoriasis would not be required.

Prurisol will be eligible for the 505(b)(2) drug approval pathway for the treatment of psoriasis. A potential application to market Prurisol will contain safety and efficacy data from studies conducted by Cellceutix, but at least some of the information required for approval may come from studies not conducted by Cellceutix. In this case, the long term safety data for Ziagen, marketed for over 15 years in the US, will be referenced.

"We are excited to enter the next phase of clinical development for Prurisol," stated Leo Ehrlich, Chief Executive Officer of Cellceutix. "There is a need for additional non-biologic treatments for chronic psoriasis and we think Prurisol has great potential based on our earlier results in an animal model of psoriasis. We look forward to the many important events happening this month at Cellceutix."

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 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.

Contact Information

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    INVESTOR AND MEDIA CONTACT:
    Cellceutix Corporation
    Leo Ehrlich
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