SOURCE: Cellceutix

October 13, 2014 09:00 ET

Cellceutix Investigational New Drug (IND) Application Becomes Effective, Selects First Site for Phase 2 Clinical Trial of New Treatment for Oral Mucositis

BEVERLY, MA--(Marketwired - Oct 13, 2014) -  Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology and antibiotic applications, is pleased to announce that its IND has become effective and that the University of Texas MD Anderson Cancer Center has been selected as a clinical site for Cellceutix's Phase 2 trial of Brilacidin-OM as a novel treatment for oral mucositis. There are currently no drugs approved by the U.S. Food and Drug Administration (FDA) for treating the approximately 500,000 people each year who have oral mucositis from head and neck cancers, a common and often debilitating condition affecting the mouth and pharynx as a side effect of certain cancer treatments, including chemotherapy and radiation therapy given. 

Cellceutix had submitted its Investigational New Drug application to the FDA in September.

This is the fourth clinical trial program at Cellceutix. The three other programs are cancer (solid tumors), Acute Bacterial Skin and Skin Structure Infections (ABSSSI), and psoriasis.

"We are extremely pleased to continue to associate our Company with the upper echelon of institutions in the country as we commence our initiatives in immunomodulatory conditions," commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. "Because we immediately advanced Brilacidin into a Phase 2b clinical trial for Acute Bacterial Skin and Skin Structure Infections (ABSSSI), many people don't realize that it was the immunomodulatory and anti-inflammatory properties of Brilacidin that we were equally as excited about, even as much as the antibiotic properties, when we acquired the defensin-mimetic franchise last year. Oral mucositis is a significant area of unmet medical need that has frustrated healthcare providers for years, which we believe our data shows Brilacidin will have a meaningful impact. We think this is just the beginning, though, as we are working on other tremendous opportunities pursuing the immunomodulatory properties of Brilacidin as we engage in studies on Crohn's Disease, Ulcerative Colitis and Inflammatory Bowel Disease, immune conditions that have repeatedly confounded scientists and left countless patients in pain with no therapeutic options."

Regarding the ABSSSI trial, which compared short-course treatments of Brilacidin to FDA-approved treatments of daptomycin, Cellceutix is pleased to update shareholders that the data from all trial sites has been locked and top-line data is expected this month.

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 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 is expected October 2014. 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.

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