Promising Ph II data for Access' OraRinse

Access Pharmaceuticals has demonstrated in a Phase II clinical trialthat OraRinse, a 0.5% solution of amlexanox (a canker sore treatment which is approved by the US Food and Drug Administration in a 5% paste formulation) which utilizes the company's mucoadhesive liquid technology, was effective in the treatment and prevention of mucositis in patients with head and neck cancers who were undergoing radiation and chemotherapy.

Study results demonstrate that, when evaluated using the oral mucositis assessment scale and compared to historical patient databases, OraRinse reduced the average severity of the disease 40%, lowered the maximum intensity 35%, and decreased the median peak intensity approximately 50%.

Access is currently evaluating the possibility of developing its mucoadhesive liquid technology for the management of the various phases of mucositis, and aims to incorporate an analgesic for pain management and compounds for the treatment of bacterial or fungal infections into the technology. Amlexanox showed no additional benefit as a prevention for mucositis with the new technology, but the company is planning further clinical studies to evaluate the product in the treatment of localized established mucositis.