PREVENTION OF ORAL MUCOSITIS EXPANDS MARKET POTENTIAL TO MULTIPLE BILLIONS OF DOLLARS

DALLAS, July 23 /PRNewswire-FirstCall/ -- ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP), announced today that its European partner, SpePharm, is collecting data from a post approval study of MuGard in head and neck cancer patients undergoing radiation treatment in the UK showing prevention of oral mucositis. In a multi-center study expected to enroll a total of 280 patients, patients are provided with seven weeks of MuGard therapy, and begin using MuGard one week prior to radiation treatment and then throughout the subsequent six weeks of planned therapy. The first 140 patients being treated in this assessment study have been enrolled and treated, and as of the time of the update, none of these patients have experienced any oral mucositis.

"The initial feedback from SpePharm on their experience in the UK, with the first 140 patients in the assessment study, exceeds our most positive expectations," stated Jeffrey B. Davis, Access' President & CEO. "Normally, roughly 100% of patients undergoing radiation treatment for head and neck cancer experience some level of oral mucositis. This condition varies from a low level of discomfort and pain, up to Grades 3 and 4 which are debilitating to the point of patients discontinuing therapy. To see a result where all or substantially all of the patients using MuGard, and using it prophylactically, are not getting oral mucositis is extremely important with respect to treatment regimens. We believe the final data set will show that MuGard should be used prophylactically with all radiation or chemotherapy regimens that have the potential to lead to oral mucositis, greatly expanding the target market."

MuGard is a novel, ready-to-use mucoadhesive oral wound rinse for the management of oral mucositis, a debilitating side effect of many anticancer treatments. Up to 40% of all patients receiving chemotherapy and/or radiotherapy develop moderate to severe mucositis, and almost all patients receiving radiotherapy for head and neck cancer and those undergoing stem cell transplantation develop mucositis. Updated clinical practice guidelines for the prevention and treatment of mucositis recommend the use of a preventive oral care regimen as part of routine supportive care along with a therapeutic oral care regimen if mucositis develops.