Access Pharmaceuticals has conducted a clinical trial of MuGard, the results of which were compared to historical data from two different groups for patients at risk of developing mucositis and who had received prior standard of care treatment. (Cancer; 1999, 85 (10): 2103-2113, and Cancer; 2000, 89 (11): 2258-2265). In both cases, it was shown mucositis scores, as measured by the oral mucositis assessment scale (OMAS), were lower for patients using MuGard than for similar patients on standard of care.
The clinical results for MuGard are shown in the following graph. This displays the average mucositis score (OMAS scale; 0=no mucositis, 5=severe mucositis) for patients during 28 weeks of radiation therapy for head and neck cancer. The patients using MuGard (red line) starting using MuGard on the first day of therapy and continued using the product throughout their cancer treatment. Retrospectively, MuGard results were compared with a very similar patient population that were on standard care for mucositis. As can be seen on the graph, their average mucositis score was much greater than that for MuGard.
One of the most striking features of a comparison of MuGard to standard of care is that 43% of patients on MuGard experienced no mucositis (OMAS score never exceeded 0.5) compared with only 7% in the historical control group. These data were one of the main factors in the FDA's decision to grant Access marketing allowance for MuGard.
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