Dr. Ron R. Allison of Carolina Radiation Medicine, Greenville, NC, has presented top-line results from a phase IV clinical trial evaluating Access Pharmaceuticals’ MuGard™ Mucoadhesive Oral Wound Rinse at the MASCC/ISOO International Symposium on Supportive Care in Cancer in Berlin, Germany. The study evaluated the efficacy of MuGard in controlling symptoms caused by oral mucositis, a side effect of some radiation and chemotherapy cancer treatments.
The presentation, entitled “The Multi-Institutional, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy of MuGard in Mitigating Oral Mucositis (OM) in Chemoradiation-Treated Head and Neck Cancer Patients” summarized top-line data on 78 of the total 120 patients who were enrolled in the study. The patients were randomized 1:1 to receive either MuGard or placebo. The analysis covered 37 evaluable MuGard patients and 41 evaluable placebo patient.
Data show that MuGard successfully met the primary study endpoint of reducing symptoms of oral mucositis, demonstrating that patients receiving MuGard experienced a statistically significant reduction versus placebo in mouth and throat soreness. In addition, the company reports that fewer patients receiving MuGard had ulcerative at the end of radiation therapy.
“For this head and neck cancer population, the debilitating side effect of oral mucositis remains one of our most significant clinical challenges. The benefits of MuGard shown in these results are critically important, both clinically and from a patient quality-of-life perspective,” Dr. Ron R. Allison, a principal investigator in the MuGard trial, Carolina Radiation Medicine, stated in the press release. “MuGard helps patients manage their mucositis during these tough treatment regimens.”
MuGard was launched in 2010 after receiving 510(k) clearance from the U.S. Food and Drug Administration – the product is available by prescription only, meeting a largely unmet need in among cancer patients receiving chemotherapy and/or radiation.
“Oral mucositis is a significant medical need for this population and these study results provide strong evidence of MuGard’s effectiveness in managing the mouth and throat soreness associated with it,” stated expert on cancer-treatment mucosal toxicities, Stephen T. Sonis, DMD, DMSc, Clinical Professor of Oral Medicine at Harvard and consultant to Clinical Assistance Programs for this trial.
For more information, visit www.accesspharma.com
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