Access Pharmaceuticals, Inc. Obtains the Rights to Amlexanox for Mucositis
DALLAS, Jan. 11 /PRNewswire/ -- Access Pharmaceuticals, Inc. (OTC Bulletin Board: AXCS) ("Access") today announced that it has signed a license agreement with Block Drug Company (Nasdaq: BLOCA) ("Block") for the rights to develop amlexanox for use in chemotherapy and radiation induced mucositis. Mucositis is a debilitating condition involving extensive inflammation of mouth tissues that affects an estimated 400,000 cancer patients in the United States undergoing chemotherapy and radiation therapy. 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(TM).
The Company 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 for which amlexanox has proven efficacy. 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. Mucositis and infection of the mouth remain major complications for cancer patients, not only causing patient discomfort, but also leading to difficulties in swallowing, nutritional deprivation and potential interruption of therapy.
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.
Mr. Gray added, "This agreement could significantly increase our revenues from the product and be an important addition to the cancer therapeutic developments in the Company. When combined with the polymer platinate program and additional technology at earlier phases of development this places the Company in a strong position to develop a significant franchise in cancer management."
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. The agreement is subject to receipt of final written consent from Takeda Chemical Industries, Ltd. |
