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Bioenvision, Inc.
New patient data generated in support of the clofarabine new drug application
September 24th, 2004
Bioenvision (Nasdaq:BIVN) announced that encouraging new patient data have been generated in support of the clofarabine new drug application (NDA) filed with the U.S. Food and Drug Administration for the treatment of refractory or relapsed acute leukemia in children. The new data submitted in the NDA included 14 additional patients: 9 with acute lymphoblastic leukemia (ALL) and 5 with acute myeloid leukemia (AML). Four of the 9 additional ALL patients responded to clofarabine (2 CR, 1 CRp, and 1 PR) and two of the additional five AML patients responded to clofarabine (2 PR). The data was generated by ILEX Oncology, Inc., Bioenvision's sub-licensor of U.S. cancer rights...
Source: Food & Drug Law Weekly (2004-09-24)
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