Coronado Biosciences (CNDO) Gets Orphan Drug Designation for CNDO-109 as AML Treatment
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Coronado Biosciences, Inc. (Nasdaq: CNDO), a biopharmaceutical company focused on the development of novel immunotherapy agents for the treatment of autoimmune diseases and cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to CNDO-109-Activated Allogeneic Natural Killer Cells (CNDO-109) for "the treatment of acute myeloid leukemia (AML)."
CNDO-109 is a biologic that activates the immune system's natural killer cells to seek and destroy cancer cells. Preclinical studies of CNDO-109 have demonstrated activity in multiple myeloma, breast cancer, prostate cancer and ovarian cancer and, based on data obtained from a Phase 1 investigator-sponsored clinical trial in patients with AML, the Company believes early efficacy was observed. Coronado currently plans to initiate a Phase 1/2 dose escalation trial in AML patients in the second half of 2012.
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CNDO-109 is a biologic that activates the immune system's natural killer cells to seek and destroy cancer cells. Preclinical studies of CNDO-109 have demonstrated activity in multiple myeloma, breast cancer, prostate cancer and ovarian cancer and, based on data obtained from a Phase 1 investigator-sponsored clinical trial in patients with AML, the Company believes early efficacy was observed. Coronado currently plans to initiate a Phase 1/2 dose escalation trial in AML patients in the second half of 2012.
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