Cellceutix Corporation, a clinical stage biotechnology company, develops and acquires small molecule therapies to treat diseases with significant medical need. Strategy The company’s strategy is to use its business and scientific expertise to maximize the value of its diverse pipeline. Kevetrin In June 2015, the company presented an overview of the company’s ongoing Phase 1 clinical trial to evaluate the safety and preliminary efficacy of Kevetrin for patients with advanced solid tumors. Prurisol In 2014, the company completed a Phase 1 study. In 2015, the company announced the commencement of the company’s Phase 2 trial of Prurisol for the treatment of plaque psoriasis, and patient recruitment is underway. The company is developing Prurisol under guidance from the U.S. Food and Drug Administration that a 505(b)(2) designation is an acceptable pathway to expedite development of the compound. Brilacidin The company is evaluating potential Contract Research Organizations and clinical sites for the global Phase 3 program. In August 2015, the company announced the addition of two clinical sites for the company’s ongoing Phase 2 clinical trial of Brilacidin-Oral Mucositis for the treatment and prevention of oral mucositis in patients with head and neck cancer, bringing the total number of sites in the study to date to five. The company is reviewing its clinical strategy and has considered advancing a topical version of Brilacidin into a European Phase 2 trial to evaluate remission of ulcerative proctitis, an idiopathic mucosal inflammatory disease and a form of ulcerative colitis involving only the rectum or the distal colon and rectum (proctosigmoiditis). The company would determine whether to advance this program only upon review of preliminary results in the oral mucositis trial. The company has developed the formulation of Brilacidin to be stable at room temperature. Other Compounds The company’s compounds include delparantag, heparin antagonist; KM 391, autism; KM 277, arthritis; KM 278, arthritis/asthma; KM 362, MS/ALS/Parkinsons; KM-3174, cancer; and KM-732,hypertensive emergency. Intellectual Property The company has assigned all right title, and interest to the following eight pharmaceutical compounds: Kevetrin, KM 277, KM 278, Prurisol, KM 362, KM 3174, KM 732, and KM-391. Regulations The Federal Food, Drug and Cosmetic Act, and other federal and state statutes and regulations, govern the testing, development, manufacture, quality control, distribution, safety, effectiveness, labeling, storage, record keeping, reporting, approval, advertising and promotion, and import and export of the company’s investigational products. History Cellceutix Corporation was founded in 2007.
cellceutix corp (CTIX:OTC US)
100 Cumming Center
Beverly, MA 01915
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