Access Sees Promise Of Amlexanox In Treatment Of Chemo-Induced Mucositis
Access Pharmaceuticals, Inc. has signed a license agreement with Block Drug Co. for the rights to develop amlexanox for use in chemotherapy and radiation induced mucositis, a debilitating condition involving inflammation of mouth tissues. Amlexanox is currently the only prescription drug approved by the FDA for the treatment of aphthous ulcers (canker sores), and is marketed by Block in the United States under the trade name Aphthasol.
Access believes amlexanox could also have a clinical benefit in the treatment of chemotherapy- and radiation-induced mucositis because of the clinical similarities of mucositis to aphthous ulcers. Approximately 40% of cancer patients who are treated with chemotherapy develop oral complications and virtually all patients who receive radiation therapy to the head and neck develops these complications.
Commenting on the agreement, Kerry P. Gray, president and CEO of Access, stated "Current therapies are aimed solely at minimizing patient discomfort. Amlexanox, as a potential treatment to minimize the extent and duration of mucositis, could emerge as an important drug addressing one of the difficult side effects in cancer treatment."
Block has filed an IND with the FDA and a Phase II protocol has been developed to investigate a mouthwash formulation for the treatment and prevention of mucositis in cancer patients undergoing bone marrow transplant. Access, in conjunction with ViroTex Corporation, is working to develop a mucoadhesive gel that can be adapted to an aerosol spray delivery system as an alternate formulation for the treatment of mucositis. This formulation could offer significant clinical advantages by adhering to the disease site for a longer duration.
Under the terms of the agreement Access has no ongoing royalty obligation to Block but will make an up-front licensing payment and will make further payments based upon the achievement of regulatory and commercial milestones.
For more information: Access Pharmaceuticals, 2600 Stemmons Frwy., Ste. 176, Dallas, TX 75207. Telephone: 214-905-5100. Fax: 214-905-5101.