Cellceutix Plans Clinical Trial in Patients With Ulcerative Proctitis

BEVERLY, MA--(Marketwired - Jan 26, 2015) - Cellceutix Corporation (OTC: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology and antimicrobial applications, is pleased to announce that it is submitting a request early this week to the Food and Drug Administration (FDA) Division of Gastroenterology and Inborn Errors Products to conduct a pre-Investigational New Drug (IND) meeting to discuss development of a topical defensin-mimetic compound for the indication of induction of remission of ulcerative proctitis and ulcerative proctosigmoiditis.

Ulcerative proctitis is a mucosal inflammatory disease of unknown cause involving only the rectum or the distal colon and rectum (proctosigmoiditis). The course of the disease is variable and ranges from complete resolution to easily maintained remission to frequent relapses or refractory disease. Oral or rectal 5-aminosalicyclic acid or corticosteroids are the initial treatments of choice. Long-term use of rectal corticosteroids should be avoided, as they have been known to produce predictable and potentially serious side effects. The Cellceutix compound offers a potential non-corticosteroid treatment that may provide anti-inflammatory effects and be of benefit to patients with these conditions.

"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," commented Dr. James Alexander, Chief Operating Officer at Cellceutix. "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."

According to estimates provided by research and consulting firm GlobalData in February 2014, the global ulcerative colitis market, which includes products for ulcerative proctitis and ulcerative proctosigmoiditis, is expected to increase at a compound annual growth rate of 4.7% from $4.2 billion in 2012 to approximately $6.6 billion by 2022. Out of the 10 major countries, the U.S. will hold just over half of the market share by 2020.