Cellceutix Seeks FDA’s Advice on Ulcerative Proctitis Therapy

Cellceutix Seeks FDA’s Advice on Ulcerative Proctitis Therapy
Clinical stage biopharmaceutical company, Cellceutix Corporation, is submitting a request to the U.S. Food and Drug Administration (FDA) for a pre-Investigational New Drug (IND) meeting. The company, which is dedicated to developing novel treatments with oncology, dermatology and antimicrobial applications, aims to discuss the creation of a new topical defensin-mimetic compound as a therapy for ulcerative proctitis and ulcerative proctosigmoiditis. Cellceutix' compound is expected to induce remission of ulcerative proctitis and ulcerative proctosigmoiditis, which are mucosal inflammatory diseases included in the group of inflammatory bowel diseases (IBD), that affect either the rectum, in the case of proctitis, or distal colon and rectum, in the case of proctosigmoiditis. A proposal that Cellceutix plans to discuss with the FDA's Division of Gastroenterology and Inborn Errors Products, according to announced in a press release. The conditions can have variable courses, from complete resolution to easily maintained remission to frequent relapses or refractory disease, and the Chief Operating Officer at Cellceutix, James Alexander, explained that "we are continuing to explore diverse indications for which we believe our defensin-mimetic franchise can improve clinical outcomes due to the anti-infective, anti-inflammatory and tissue healing properties of these compounds." "We see a tremendous opportunity in the ulcerative colitis market and more broadly as a potential treatment for different gastrointestinal diseases, such as Crohn's disease. A pre-IND meeting with the FDA is the first step down the path to our goal of initiating a clinical trial during 2015 and expanding our clinical pipeline into these lucrative markets of unmet medical need," Alexan
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