Cellceutix Seeks FDA’s Advice on Ulcerative Proctitis Therapy

Cellceutix Seeks FDA’s Advice on Ulcerative Proctitis Therapy

cellceutixClinical 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,” Alexander added.

The causes for the development of ulcerative proctitis and ulcerative proctosigmoiditis are not yet known, but the conditions are often initially treated with oral or rectal 5-aminosalicyclic acid or corticosteroids. However, using rectal corticosteroids for a long period of time is not recommended, since it is known to provoke predictable and potentially serious side effects. Therefore, Cellceutix aims to provide a non-corticosteroid therapeutic option that offers not only anti-inflammatory effects, but also benefits for the patients.

In addition, Cellceutix is looking forward to enter the global ulcerative colitis market, with its therapeutic options for ulcerative proctitis and ulcerative proctosigmoiditis, since recent data from GlobalData revealed an annual growth rate of 4.7% in the market,  from $4.2 billion in 2012 to about $6.6 billion by 2022. Moreover, the United States are expected to gain half of this market share until 2020.