AMAG Pharma Announces Publication of Data from Trial of MuGard in the Journal Cancer

AMAG Pharmaceuticals, Inc. AMAG today announced that the publication of data from a multi-institutional trial of MuGard has been featured in the print edition of the journal Cancer, available today. MuGard is a mucoadhesive hydrogel that forms a protective coating over the oral mucosa. The randomized, double-blind, placebo-controlled trial showed MuGard was more effective than a sham-control in significantly reducing the mouth and throat soreness associated with oral mucositis, a common and debilitating side effect of radiotherapy used to treat patients with head and neck cancer. Of 120 patients participating in the trial, 60 received MuGard and 60 received saline-bicarbonate rinse as a sham-control. The study's primary endpoint was a reduction in mouth and throat soreness as assessed daily by a validated patient questionnaire. Efficacy was assessed in the 78 patients who received at least 1 dose of study rinse within 2.5 weeks of starting radiation therapy. Compared to control patients, MuGard-treated patients had significantly less mouth and throat soreness over the course of the study (p=0.034). On the last day of radiation therapy, a physician-based assessment found that significantly fewer MuGard-treated patients had ulcerative oral mucositis than those patients treated with the saline-bicarbonate control (43% vs. 68%; p=0.038). "Oral mucositis continues to be a significant unmet medical need with symptomatic consequences, and this multi-institutional study provides strong evidence of MuGard's effectiveness in mitigating the symptoms of oral mucositis," said Stephen T. Sonis, DMD, DMSc, an expert on cancer treatment complications, Clinical Professor of Oral Medicine at Harvard and the primary author of the protocol for this trial. "This rigorous clinical trial design sets a new standard for evidence supporting the use of agents in this class." No difference in adverse effects was observed between patients receiving MuGard and those patients receiving the saline-bicarbonate control. No patients discontinued MuGard because of an adverse effect while two patients using the sham-control discontinued due to nausea or vomiting. "This research demonstrates that MuGard is effective in managing oral mucositis, a serious and common side effect of radiation therapy in cancer patients," said Dr. Robert Kaper, senior vice president of medical and scientific affairs at AMAG Pharmaceuticals, the company that markets MuGard in the U.S. "AMAG is committed to educating patients and health care providers about the seriousness of oral mucositis and the role MuGard can play in managing the condition." This study was supported by Access Pharmaceuticals, Inc. About Oral Mucositis Oral mucositis is a painful inflammation and ulceration of the lining of the mouth. It is a common side effect of many of the radiotherapy and chemotherapy regimens used to treat cancer and affects almost 400,000 patients in the U.S. Its presence creates a significant burden of illness for cancer patients and is associated with weight loss, increased narcotic use, unplanned visits to physicians or the emergency room and hospital admission. The incremental cost of oral mucositis in patients with head and neck cancer is approximately $18,000.