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Cellceutix Identifies Drug Candidates for Gram-Negative and Candida Fungal Infections


Cellceutix Identifies Drug Candidates for Gram-Negative and Candida Fungal Infections

Company Completing IND Application to Commence Clinical Trial of New Psoriasis Drug Prurisol

BEVERLY, MA -- (Marketwired) -- 11/18/13 -- Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, is pleased to report that it has made significant breakthroughs with its portfolio of novel drug candidates for infectious disease, including fungal infections and Gram-negative bacterium. Extensive screening has identified five promising drug candidates for fungal infections, including PMX1502 and PMX1408 as stand-outs for anti-Candida fungal activity to be used for both oral and disseminated candidiasis. Current therapies today are not only relatively ineffective, but are seriously limited by recurrence, resistance and systemic toxicity.

In particular, PMX1502 shows robust efficacy, systemic use and selectivity in a disseminated candidiasis animal model. The compound showed cidal activity rather than static effect and significant reduction in fungal tissue burden. The activity of PMX1408 against Candida and Aspergillus warrants further development of the compound as a topical treatment for hard-to-treat infections. Given the limitations of current standards of care, the Company believes that new drugs for treatment of these indications are highly desirable.

Drug-resistant bacteria are quickly becoming a source of global concern and were recently the subject of a World Health Organization warning in listing antibiotic resistance as one of the top three public health threats of this century. According to a special editorial in the Lancet this month, "superbugs," or drug-resistant bacteria, threaten to erase a century of medical advances. This has created an urgent need for development of new drugs, especially for drugs focused on Gram-negative infections, which are typically far more difficult to treat than Gram-positive infections.

"The alarms have sounded globally, signaling the dire need for new antibiotics and the premium prices that promising compounds can command. Roche recently jumped back into the antibiotic markets by agreeing to pay up to $548 million for a Phase II antibiotic targeting Gram-negative pathogens," said Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. "We believe there is a great interest in the pharmaceutical industry for clinical-stage gram-negative compounds. We are extremely motivated to move the drugs forward as quickly as possible to satisfy this interest. The latest research with PMX1502 and PMX1408 well positions us to move into the multi-billion-dollar anti-fungal and Gram-negative bacterium markets. We knew we were gaining substantial assets with the PolyMedix acquisition, but this is evolving into more than even I expected at this point."

Regarding bacterial infections, Cellceutix researchers have identified a series of host defense protein (HDP)-mimetic compounds that rapidly kill a variety of clinically-important Gram-negative pathogens. Infections caused by these pathogens are very difficult to treat because the bacteria are typically multi-drug resistant, which can lead to life-threatening conditions. The Company's compounds are active against some of the most problematic pathogens, such as Pseudomonas aeruginosa, Klebsiella pneumoniae, Escherichia coli and Acinetobacter baumannii as well as highly multi-drug resistant ndm-1-producing K. pneumoniae. The Company's compounds exhibit low toxicity against mammalian cell types, with in vivo studies showing several of the compounds to be active in animal infection models.

Separately, Cellceutix today announced that it has received the Chemistry, Manufacturing and Controls ("CMC") section from NYSE-listed Dr. Reddy's Laboratories Ltd. required for its Investigational New Drug ("IND") application for Prurisol, the Company's lead anti-psoriasis compound.

Cellceutix's dermatology team is currently incorporating the CMC section into the IND for submission to the U.S. Food and Drug Administration ("FDA"). The Company is developing Prurisol under FDA guidance that a 505(b)(2) designation is an appropriate developmental pathway.

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 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 a Phase 2/3 clinical trial 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 the first half of 2014 for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Brilacidin has the potential to be a single-dose therapy for multi-drug resistant bacteria or a dosing regimen that is shorter than currently marketed antibiotics. 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: INVESTOR AND MEDIA CONTACT: Cellceutix Corp. Leo Ehrlich (978) 236-8717 info@cellceutix.com

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