Access Files IND for OraRinse(TM) With the FDA
DALLAS, Jan. 11 /PRNewswire/ -- Access Pharmaceuticals, Inc. (OTC Bulletin Board: AXCS - news) today announced that it has filed an IND with the FDA for OraRinse(TM), amlexanox 0.5% mouth rinse for the prevention and treatment of mucositis in patients undergoing radiation and chemotherapy. The Company plans to commence clinical studies immediately upon receipt of approval of the IND.
Amlexanox in a 5% oral paste has been approved by the FDA for the treatment of aphthous ulcers, and is marketed in the United States by Block Drug Company. Access has licensed the worldwide rights from Block Drug Company for the use of amlexanox in the mucositis indication.
Mucositis is a debilitating condition involving extensive inflammation and ulceration of soft tissue in the mouth and throat that affects an estimated 400,000 cancer patients in the United States undergoing chemotherapy and radiation treatment. A treatment that would reduce the disease occurrence or accelerate healing would have a significant beneficial impact on the quality of life of these patients and may allow for more aggressive chemotherapy.
Kerry P. Gray, President and CEO of Access stated, ``Amlexanox is a drug with exciting potential in numerous oral and topical diseases as it has multiple mechanisms of action that impact inflammatory conditions. Mucositis is potentially the largest indication for amlexanox, as the worldwide market for the mucositis indication is projected to be in excess of $1 billion and there are currently no products approved for the prevention and treatment of this disease.'
In addition to the clinical data supporting the use of amlexanox for the treatment of canker sores, Access has recently completed a pilot oral wound healing study which generated positive results. Gray continued, ``The positive data previously generated in canker sores and more recently in oral wound healing is very encouraging, which supports the development of amlexanox for mucositis.'
Access Pharmaceuticals, Inc. is an emerging pharmaceutical company focused on developing both novel low development risk product candidates and technologies with longer-term major product opportunities. In conjunction with Block Drug Company, Access has developed Aphthasol(TM), the only FDA- approved product for the treatment of canker sores, and is developing Amlexanox for mucositis and other topical diseases. Access is currently developing a unique polymer platinate for use in the treatment of cancer and is developing in conjunction with its partner Strakan, Ltd. a topical zinc delivery system called ResiDerm© that provides rapid delivery and reservoir of a drug in the skin. |
