BEVERLY, MA--(Marketwired - May 5, 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 first cohort of patients has successfully completed enrollment in the Company's clinical trial of anti-psoriasis drug candidate Prurisol™.
The first cohort received 50mg of Prurisol™, with no treatment-related serious adverse events or dose-limiting toxicity reported. Cellceutix has been advised that a dose escalation to 100mg has been approved for the second cohort and enrollment is underway. The primary endpoint in the clinical trial is to show that Prurisol™ safely converts to abacavir in healthy humans as it did in animal models.
"We are very happy to have completed the first cohort and with the progression of the study to date," commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. "Enrollment is going very smoothly and we are optimistic that patient enrollment will be successfully completed in mid-June. That will set the stage for us to move forward into a Phase 2/3 trial under guidance from the Food and Drug Administration that a 505(b)(2) pathway is an acceptable approach for accelerated development of Prurisol™."
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.
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