SOURCE: Cellceutix

Cellceutix

July 21, 2016 07:00 ET

Cellceutix Expedites Phase 2 Trial of Brilacidin-OM For Oral Mucositis

BEVERLY, MA --(Marketwired - July 21, 2016) - Cellceutix Corporation, (OTCQB: CTIX) ("the Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, antibiotic, and anti-inflammatory applications, is pleased to provide additional information in the ongoing, Phase 2 clinical trial of Brilacidin-OM for the treatment of oral mucositis (OM), a serious and debilitating complication of radiation and chemotherapy for head and neck cancer.

Cellceutix has recently retained several experienced OM consultants and embarked on a rapid expansion of the study with a goal of completing its study enrollment on an expedited basis. The Company also has been advised that a competing OM trial, which announced recently that it is being discontinued, has resulted in the availability of a large number of clinical sites, that are being considered to participate in the Cellceutix trial. Cellceutix expansion of the study assures that it will be working with sites and investigators possessing a keen understanding of the unique challenges of OM trials and a proven track record of reliable patient recruitment and retention.

"Cellceutix is committed to completing its ongoing study of Brilacidin-OM for the benefit of patients at risk for developing oral mucositis and we are optimistic that the promising preclinical results from an established and predictive laboratory animal model will be replicated in this study," commented Dr. Arthur P. Bertolino, President and Chief Medical Officer at Cellceutix. "While we can never predict with certainty what will happen when we transition from the laboratory to the clinic, we certainly can take steps to expedite the clinical trial process and maximize the probability of success. We are pleased to have engaged groups with proven track records to get us to the finish line in an efficient and capable manner."

As disclosed on Monday, July 18, 2016, Cellceutix received positive feedback from the first patient treated in a Phase 2 Proof-of-Concept (P-o-C) trial of Brilacidin for ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). While this commentary was only for one patient, it is relevant to Cellceutix management and shareholders, as OM, UP and UPS are all conditions where inflammation plays a significant role. The open-label design of the P-o-C trial, compared to the double-blind design of the OM trial, was the first opportunity for Cellceutix to know with certainty that the subject was treated with Brilacidin. Albeit very early feedback, the Company views the positive feedback as supportive of the anti-inflammatory properties demonstrated in the preclinical research of Brilacidin and the potential for these properties to help patients with OM.

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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 plans for a Phase 2 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™ completed a Phase 2 trial and Cellceutix is now setting up a Phase 2b study. 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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