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FDA Grants Orphan Drug Designation To Trisenox (Arsenic Trioxide) For Treatment Of Chronic And Acute Myeloid Leukemia SEATTLE, WA -- November 29, 2001 -- Cell Therapeutics, Inc.'s novel cancer drug treatment, Trisenox (arsenic trioxide) injection has been granted orphan drug designation for the treatment of both chronic myeloid (CML) and acute myelocytic (AML) leukemias by the U.S. Food and Drug Administration (FDA). CTI is in the process of studying Trisenox as a single agent and in combination with Gleevec™ for CML in chronic, accelerated and blast crises. In addition, the National Cancer Institute is sponsoring several clinical trials that are in Phase II for AML. "With these two new designations, we now have five orphan drug designations for Trisenox, including myelodysplastic syndromes, multiple myeloma and acute promyelocytic leukemia," stated Carolyn Paradise, M.D., Executive Vice President of Clinical Operations at CTI. According to The Leukemia & Lymphoma Society, nearly 15,000 new patients are diagnosed with CML or AML every year in the United States. CML is a moderately progressive form of leukemia that is characterized by the presence of large numbers of granulocytes in the blood and AML is a progressive leukemia that starts by the malignant transformation of an immature cell in the bone marrow. Orphan drug designation is granted to applicants when the prevalence of the disease occurs in fewer than 200,000 patients in the United States. The FDA has established procedures for orphan designation which are intended to encourage sponsors to develop drugs for patients with rare diseases. The FDA may also work with sponsors to facilitate the development process. SOURCE Cell Therapeutics, Inc. E-mail this page to a friend or colleague! To print, use this version