Access Pharmaceuticals Licenses Amlexanox for Treatment of Mucositis
Access Pharmaceuticals, Inc. has announced a license agreement with Block Drug Company for the rights to develop amlexanox for use in chemotherapy and radiation-induced mucositis. Mucositis is a debilitating condition affecting an estimated 400,000 cancer patients in the United States, involving extensive inflammation of mouth tissues. Amlexanox, currently approved by the FDA for the treatment of aphthous ulcers (canker sores), has shown efficacy in treating mucositis due to its clinical similarities to aphthous ulcers. Approximately 40% of cancer patients treated with chemotherapy develop oral complications, and virtually all patients receiving radiation therapy to the head and neck develop these complications.
Key Takeaways:
- Access Pharmaceuticals has licensed amlexanox from Block Drug Company for the treatment of chemotherapy and radiation-induced mucositis.
- Mucositis is a debilitating condition affecting an estimated 400,000 cancer patients in the United States, involving extensive inflammation of mouth tissues.
- Amlexanox has shown efficacy in treating mucositis due to its clinical similarities to aphthous ulcers for which it is currently approved by the FDA.
- Approximately 40% of cancer patients treated with chemotherapy develop oral complications, and virtually all patients receiving radiation therapy to the head and neck develop these complications.
- Access Pharmaceuticals is working with ViroTex Corporation to develop a mucoadhesive gel that can be adapted to an aerosol spray delivery system for the treatment of mucositis.
- 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.
- The agreement is subject to receipt of final written consent from Takeda Chemical Industries, Ltd.
Statistics:
- Estimated 400,000 cancer patients are affected by mucositis in the United States (Source: Block Press Release).
- Approximately 40% of cancer patients treated with chemotherapy develop oral complications (Source: Block Press Release).
- Virtually all patients receiving radiation therapy to the head and neck develop oral complications (Source: Block Press Release).
Sources:
- Block Press Release, dated January 11 (no year provided).
- Access Pharmaceuticals' Annual Report on Form 10-K for the year ended December 31, 1997.