|By Marketwired .||
|May 19, 2014 07:00 AM EDT||
BEVERLY, MA -- (Marketwired) -- 05/19/14 -- 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 its lead antibiotic, Brilacidin, demonstrated visually convincing wound healing properties in a recently completed experiment in a diabetic rat model.
As a small molecule mimetic of human host defense proteins, brilacidin has demonstrated antibacterial and tissue healing properties on barrier surfaces, such as skin and mucous membranes. Results from the diabetic rat study are consistent with these properties.
In the study, diabetic rats with similar non-infected diabetic wounds were treated with Brilacidin for five days and compared to an untreated control. By visual inspection, the brilacidin-treated animals experienced a more rapid and complete reduction in the area of the wound. Additional experiments are now scheduled in infected diabetic wound models. Afterwards, the Company anticipates entering the necessary clinical trials.
The accompanying image is from the research showing the improvement in wound healing in a diabetic rat model following five days of treatment with Brilacidin: http://media.marketwire.com/attachments/201405/75445_brilacidin.jpg
"We already know that Brilacidin has strong anti-infective properties, so the trial was designed to validate our contention that the drug also expedites the healing process in wounds that are free of infection; a powerful one-two punch in the treatment of diabetic foot wounds, regardless of infection," commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. "Through the combination of our internal research and the ongoing Phase 2b clinical trial of Brilacidin for ABSSSI, we are rapidly growing a large body of evidence demonstrating the potential clinical benefits of Brilacidin across a broad spectrum of indications of great unmet medical need. Last week, we moved one step closer to the initiation of a Phase 2 clinical trial of Brilacidin for oral mucositis through the receipt of the draft GLP toxicology report. We expect the final report within the next few weeks, at which time we will add it to the Investigational New Drug application for submission to the U.S. Food and Drug Administration."
Because of compromised peripheral nerves and blood vessels, diabetic foot wounds readily become a chronic condition and represent a leading cause of hospitalization and amputation for the approximately 26 million people living with diabetes in the United States. Most of these wounds, at one time or another, get infected. According to the American Podiatric Medical Association, a chronic diabetic foot wound occurs in approximately 15 percent of people with diabetes. Of those patients, up to 18 - 24 percent will require an amputation. Cellceutix believes the market size for an effective treatment is significantly larger than the ABSSSI market that alone is greater than a billion dollars in the U.S., thus the Company is targeting a potential multibillion-dollar worldwide market.
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 presently in a bioequivalence crossover clinical trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's key antibiotic, Brilacidin, is in a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Brilacidin has the potential to be a single-dose therapy or a dosing regimen that is shorter than currently marketed antibiotics 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.
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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