BEVERLY, MA--(Marketwired - March 19, 2014) - Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, announces today that the seventh cohort is now in progress in the Company's ongoing Phase 1 clinical trial of Kevetrin™, Cellceutix's novel anti-cancer drug candidate.
The seventh cohort dosing is 165 mg/m2 of Kevetrin™, compared to 110 mg/m2 in the prior cohort. Cellceutix is pleased to report that Maximum Tolerated Dose (MTD) has yet to be reached through the completion of six cohorts.
As announced on January 15, the U.S. Food and Drug Administration approved an amendment to the trial protocol to limit the maximum infusion timeframe to six hours throughout the remainder of the trial. The implementation of the amendment at the two hospitals took approximately two months.
"We are excited that the seventh cohort is underway as we feel that we are drawing closer to achieving MTD, which represents a milestone for our Company," commented Leo Ehrlich, Chief Executive Officer of Cellceutix. "The internal procedures at the clinical sites have moved a little more slowly than we hoped, but that is beyond our control and not out of the ordinary when working with some of the world's leading cancer research centers. Kevetrin is in great hands and we are glad to be moving towards completion of this study. On another note, we have been updated that enrollment in our Phase 2b clinical trial of Brilacidin for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) is progressing smoothly across multiple sites. We are very pleased with the clinical development of both of these novel compounds."
The clinical trial of Kevetrin is an open-label, dose-escalation study being conducted at Harvard University's Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center to assess the safety and tolerability of Kevetrin™, a small molecule compound shown in the laboratory to activate the key tumor suppressor protein p53, in patients with advanced solid tumors. Additional information on the trial can be found at: http://www.clinicaltrials.gov/ct2/show/NCT01664000?term=cellceutix+kevetrin&rank=1
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 being readied for clinical trials at sites in the U.S. and Europe. 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.