BEVERLY, MA--(Marketwired - December 09, 2013) - Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, today updates shareholders on recent developments and future plans. A comprehensive update will be provided to shareholders in mid January 2014.
Prurisol: Cellceutix has corresponded with the U.S. Food and Drug Administration (FDA) in preparation for clinical trials of Prurisol as a new oral drug candidate for psoriasis. The FDA has advised the Company that a 505(b)(2) designation is an appropriate pathway for development of Prurisol. Because Prurisol is an ester of abacavir, the FDA has requested that Cellceutix conduct a short Phase 1 crossover study to demonstrate that Prurisol converts into abacavir in humans before initiating a larger-scale Phase 2/3 trial. Cellceutix is selecting the site for this study and the protocol will be submitted to the site's Institutional Review Board (IRB) for approval. Cellceutix plans to accomplish this by the end of this month. It is anticipated that the trial will take one month to complete.
Brilacidin for Acute Bacterial Skin and Skin Structure Infections (ABSSSI): The Company has selected clinical sites for the phase 2b trial and is finalizing requisite documentation for submission to the respective Institutional Review Boards by the end of this month. The Investigational New Drug application for Brilacidin for ABSSSI is active with the U.S. Food and Drug Administration (FDA). After IRB approval, the Company may immediately commence with its Phase 2b clinical trial, which is planned for January 2014.
Kevetrin: The sixth cohort has completed dosing in the Phase 1 clinical trial of the Company's anti-cancer drug Kevetrin being hosted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center. The safety committee is scheduled to meet in mid-December to define the increased dose for the seventh cohort. Maximum tolerated dose of Kevetrin has not yet been reached. Further, Cellceutix has filed an amendment to the trial protocol with the FDA to limit the dosing duration of Kevetrin to six hours. Cellceutix filed the amendment to keep the dosing time frame within a reasonable number of hours as the dosing level increases as the trial progresses.
In addition to the above listed projects, Cellceutix staff is conducting research with Brilacidin for oral mucositis, ophthalmic diseases and otitis as well as other projects previously announced.
Leo Ehrlich, Chief Executive Officer of Cellceutix, commented, "Since last month's Elsevier conference, we have entered into two confidentiality agreements with multi-billion dollar companies interested in our pipeline. We have a lot to accomplish over the coming weeks, which should set Cellceutix up for an exciting new year. We will provide shareholders with a more comprehensive update during the JP Morgan conference in January 2014."
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 a Phase 2/3 clinical trial 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 set to begin a Phase 2b trial in the first half of 2014 for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Brilacidin has the potential to be a single-dose therapy for multi-drug resistant bacteria or a dosing regimen that is shorter than currently marketed antibiotics. 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.