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Arsenic Trioxide Receives FDA Orphan Drug Designation For Myelodysplastic Syndromes SEATTLE, WA -- July 18, 2000 -- Cell Therapeutics, Inc.'s (cti) novel cancer drug treatment, Arsenic TriOxide (ATO), has been granted orphan drug designation for the treatment of myelodysplastic syndromes (MDS) by the U.S. Food and Drug Administration (FDA). MDS, also called pre-leukemia or "smoldering" leukemia, are diseases in which the bone marrow does not function normally and not enough normal blood cells are made. MDS may develop following treatment with drugs or radiation therapy for other diseases, or it may develop without any known cause. An estimated 30,000 to 40,000 people in the United States suffer from MDS. Approximately 40 percent of patients will die from the consequences of ineffective blood cell production and 30 percent will progress to develop acute leukemia, a form of cancer where too many white blood cells are made. Advanced stages of the disease require treatment with chemotherapy and/or bone marrow transplantation, which are ineffective in the majority of cases. In May, Arsenic TriOxide also received orphan drug designation in the treatment of multiple myeloma, a type of bone marrow cancer. On March 29, 2000, the company announced it had submitted a New Drug Application (NDA) with ATO for the treatment of patients with relapsed or refractory acute promyelocytic leukemia. ATO has also received both orphan drug designation and fast-track designation from the FDA for the treatment of patients with this disease. Orphan drug designation is granted to applicants when the prevalence of the disease occurs in less than 200,000 patients in the United States. By designating a product as an "Orphan Product", the FDA establishes procedures intended to encourage sponsors to develop drugs for patients with rare diseases. The FDA also works with sponsors to facilitate the development process. E-mail this page to a friend or colleague! To print, use this version