Addresses large unmet medical need. Presently no drug is approved by the FDA for the indication.
BEVERLY, MA–(Marketwired – May 26, 2015)– Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, and antibiotic applications, is pleased to announce that enrollment has commenced in the Company’s Phase 2 clinical trial of Brilacidin-OM for the prevention and treatment of oral mucositis in patients undergoing chemoradiation for treatment of head and neck cancer.
The randomized, double blind, multi-center trial will evaluate Brilacidin-OM oral rinse compared to a placebo rinse with the primary efficacy endpoint assessed by means of the WHO oral mucositis score at multiple timepoints during the trial. Additional information, including secondary endpoints, are available on the ClinicalTrials.gov website at: https://clinicaltrials.gov/ct2/show/NCT02324335?term=cellceutix&rank=2
Cellceutix has provided the requisite information and expects the clintrials.gov website to change the study status to “enrolling” shortly.
Cellceutix’s Brilacidin-OM is structurally very different from any available therapeutics for people suffering the often debilitating effects of oral mucositis. Today’s treatments are typically only minimally effective palliative coatings, rather than prophylactic in nature and do not truly address the underlying cause as the Company believes its drug candidate does. Cellceutix has seen promising evidence as to the anti-biofilm and anti-inflammatory benefits of Brilacidin-OM in laboratory research and this Phase 2 trial is an important step in advancing the clinical development plan for Brilacidin-OM as a new approach to the prevention of oral mucositis. With the 21st Century Cures FDA reform bill receiving unanimous approval from the House Energy and Commerce Committee last week, Cellceutix believes that it is in the right place at the right time with the start of this trial, as well as other novel clinical studies in its pipeline.
Oral mucositis is a common and often debilitating inflammation and ulceration that occurs in the mouth as a side effect of certain cancer treatments, afflicting approximately 450,000 patients each year in the United States and affects the course and outcome of cancer therapy. In addition to increasing patient risk and discomfort, oral mucositis is also associated with increased treatment costs of up to $25,000 per patient. Despite these numbers, there are no effective pharmacological therapeutic options for this condition and treatment today is mostly focused on pain management.