SOURCE: Cellceutix

January 26, 2015 07:00 ET

Cellceutix Plans Clinical Trial in Patients With Ulcerative Proctitis

Company Actively Moving Forward With Its Intentions to Uplist to the NASDAQ Exchange

BEVERLY, MA--(Marketwired - Jan 26, 2015) - Cellceutix Corporation (OTC: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology and antimicrobial applications, is pleased to announce that it is submitting a request early this week to the Food and Drug Administration (FDA) Division of Gastroenterology and Inborn Errors Products to conduct a pre-Investigational New Drug (IND) meeting to discuss development of a topical defensin-mimetic compound for the indication of induction of remission of ulcerative proctitis and ulcerative proctosigmoiditis.

Ulcerative proctitis is a mucosal inflammatory disease of unknown cause involving only the rectum or the distal colon and rectum (proctosigmoiditis). The course of the disease is variable and ranges from complete resolution to easily maintained remission to frequent relapses or refractory disease. Oral or rectal 5-aminosalicyclic acid or corticosteroids are the initial treatments of choice. Long-term use of rectal corticosteroids should be avoided, as they have been known to produce predictable and potentially serious side effects. The Cellceutix compound offers a potential non-corticosteroid treatment that may provide anti-inflammatory effects and be of benefit to patients with these conditions.

"We are continuing to explore diverse indications for which we believe our defensin-mimetic franchise can improve clinical outcomes due to the anti-infective, anti-inflammatory and tissue healing properties of these compounds," commented Dr. James Alexander, Chief Operating Officer at Cellceutix. "We see a tremendous opportunity in the ulcerative colitis market and more broadly as a potential treatment for different gastrointestinal diseases, such as Crohn's disease. A pre-IND meeting with the FDA is the first step down the path to our goal of initiating a clinical trial during 2015 and expanding our clinical pipeline into these lucrative markets of unmet medical need."

According to estimates provided by research and consulting firm GlobalData in February 2014, the global ulcerative colitis market, which includes products for ulcerative proctitis and ulcerative proctosigmoiditis, is expected to increase at a compound annual growth rate of 4.7% from $4.2 billion in 2012 to approximately $6.6 billion by 2022. Out of the 10 major countries, the U.S. will hold just over half of the market share by 2020.

Cellceutix is also pleased to inform shareholders that due to recently reported positive events, the Company is actively moving forward with its intentions to uplist to the NASDAQ exchange and is meeting today with its legal counsel, K&L Gates (www.klgates.com), to review the Company's application for a move to the senior exchange.

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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 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 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 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 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.

Contact Information

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