BEVERLY, MA--(Marketwired - May 26, 2015) - Cellceutix Corporation (
The randomized, double blind, multi-center trial will evaluate Brilacidin-OM oral rinse compared to a placebo rinse with the primary efficacy endpoint assessed by means of the WHO oral mucositis score at multiple timepoints during the trial. Additional information, including secondary endpoints, are available on the ClinicalTrials.gov website at: https://clinicaltrials.gov/ct2/show/NCT02324335?term=cellceutix&rank=2
Cellceutix has provided the requisite information and expects the clinicaltrials.gov website to change the study status to "enrolling" shortly.
Cellceutix's Brilacidin-OM is structurally very different from any available therapeutics for people suffering the often debilitating effects of oral mucositis. Today's treatments are typically only minimally effective palliative coatings, rather than prophylactic in nature and do not truly address the underlying cause as the Company believes its drug candidate does. Cellceutix has seen promising evidence as to the anti-biofilm and anti-inflammatory benefits of Brilacidin-OM in laboratory research and this Phase 2 trial is an important step in advancing the clinical development plan for Brilacidin-OM as a new approach to the prevention of oral mucositis. With the 21st Century Cures FDA reform bill receiving unanimous approval from the House Energy and Commerce Committee last week, Cellceutix believes that it is in the right place at the right time with the start of this trial, as well as other novel clinical studies in its pipeline.
Oral mucositis is a common and often debilitating inflammation and ulceration that occurs in the mouth as a side effect of certain cancer treatments, afflicting approximately 450,000 patients each year in the United States and affects the course and outcome of cancer therapy. In addition to increasing patient risk and discomfort, oral mucositis is also associated with increased treatment costs of up to $25,000 per patient. Despite these numbers, there are no effective pharmacological therapeutic options for this condition and treatment today is mostly focused on pain management.
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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 has begun 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.
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Cellceutix Corporation
Leo Ehrlich