|By Marketwired .||
|June 2, 2014 07:00 AM EDT||
BEVERLY, MA -- (Marketwired) -- 06/02/14 -- Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, reports today that patient enrollment has been completed in the Company's Phase 1 crossover study of its anti-psoriasis drug candidate Prurisol. Cellceutix expects lab results, pharmacokinetic studies, and analysis to take approximately two months. If the data shows bioequivalence of Prurisol with Abacavir Sulfate, the Company will then schedule a meeting with the U.S. Food and Drug Administration regarding initiating a Phase 2/3 trial of Prurisol through the 505(b)(2) regulatory pathway.
Cellceutix would also like to update shareholders on other ongoing clinical trials and laboratory research. The seventh cohort has been completed in the Phase 1 trial of the Company's anti-cancer drug candidate Kevetrin being conducted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center. The safety committee is scheduled to meet next week to determine the dosing amount for the eighth cohort. Cellceutix anticipates that dosing will be increased by about 33 percent, or approximately 215 mg/m2, but there are no assurances as any dosing increases are at the sole discretion of the safety committee. As of today, the Maximum Tolerated Dose (MTD) of Kevetrin has not yet been reached.
The Phase 2b trial of Cellceutix's antibiotic Brilacidin is progressing as planned with approximately 60 percent of patient enrollment completed. As of today, no drug-related serious adverse events have been reported in the trial.
Separately, Cellceutix last week entered into a research agreement with a renowned non-profit research institution for studies of anti-fungal compounds in Cellceutix's portfolio. The research is to be funded by a $1.5 million grant from the National Institute of Health, Small Business Innovation Research (SBIR) to the non-profit institution. A Notice of Grant Award Letter has been issued, but funding has not yet commenced.
"We are very proud of how much we have grown in the past eight months at Cellceutix and how many wheels are in motion studying our extensive portfolio from early stages to nearing completion of a Phase 2b trial," commented Leo Ehrlich, Chief Executive Officer at Cellceutix. "In addition to the aforementioned clinical trials, we have antibiotic and antifungal compounds being studied at various leading universities across the country; Brilacidin studies for diabetic foot ulcers ongoing; the Investigational New Drug application being completed for a Phase 2 trial of Brilacidin for oral mucositis; formulation work being conducted on Brilacidin for ophthalmic and otitis therapies; and other research happening for new drugs. While that's a mouthful, it still only covers a portion of the day-to-day developments at our Company as we relentlessly strive to meet our goals of providing therapies for great unmet medical need and delivering strong shareholder value."
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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