BEVERLY, MA--(Marketwired - June 16, 2014) - 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 the safety committee overseeing the Phase 1 clinical trial evaluating Cellceutix's lead anti-cancer drug Kevetrin for solid tumors being conducted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center has approved dosing for the eighth cohort. The dosing was been increased approximately 33 percent from the seventh cohort to 215 mg/m2. Enrollment for the eighth cohort is expected to commence shortly.
Cellceutix would also like to inform shareholders that enrollment in the Phase 2b clinical trial of Brilacidin for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) is approximately 70 percent complete. To date, no drug-related serious adverse events have been reported.
The Company has been advised that the Brilacidin safety committee meeting is scheduled for the end of June. Cellceutix anticipates providing shareholders with an update on data from the trial and any commentary from the safety committee in the first half of July.
Cellceutix is delighted by the recent release of the final rule by the U.S. Food and Drug Administration list of qualifying pathogens under the Generating Antibiotic Incentives Now (GAIN) Act. The list is advantageous to our Company's robust portfolio of defensin mimetics, as the list contains many of the pathogens we are working on. We expect to benefit from the regulatory framework of the GAIN Act to expedite development. Interested parties are encouraged to read the Federal Register to learn more about the final rule list by the U.S. Food and Drug Administration at: http://www.gpo.gov/fdsys/pkg/FR-2014-06-05/pdf/2014-13023.pdf.
Additionally, Cellceutix has been informed that the U.S. Patent and Trademark Office has issued a Notice of Allowance for the U.S. Patent Application No. 13/730247 "Carbocyclic Nucleosides And Their Pharmaceutical Use And Composition" with claims covering Cellceutix's compound Prurisol. Cellceutix announced on June 2, 2014 that it has completed enrollment in a Phase 1 crossover study of Prurisol as a new drug candidate for the treatment of psoriasis and that lab results, pharmacokinetic studies, and analysis are expected to take approximately two months.
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.