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June 16, 2014
07:13 EDTCTIXCellceutix clinical trial of anti-cancer drug Kevetrin entering eighth cohort
Cellceutix reports 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 has been increased approximately 33% 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 is approximately 70% 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.
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October 13, 2014
09:03 EDTCTIXCellceutix IND application becomes effective
Cellceutix announced that its IND has become effective and that the University of Texas MD Anderson Cancer Center has been selected as a clinical site for Cellceutix's Phase 2 trial of Brilacidin-OM as a novel treatment for oral mucositis. There are currently no drugs approved by the FDA for treating the approximately 500,000 people each year who have oral mucositis from head and neck cancers, a common and often debilitating condition affecting the mouth and pharynx as a side effect of certain cancer treatments, including chemotherapy and radiation therapy given. Cellceutix had submitted its Investigational New Drug application to the FDA in September. This is the fourth clinical trial program at Cellceutix. The three other programs are cancer, Acute Bacterial Skin and Skin Structure Infections, and psoriasis.

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