Coronado Biosciences Inc. (CNDO) announced that the U.S. Food and Drug Administration or FDA has granted orphan-drug designation to CNDO-109-Activated Allogeneic Natural Killer Cells or CNDO-109 for "the treatment of acute myeloid leukemia or 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 said it currently plans to initiate a Phase 1/2 dose escalation trial in AML patients in the second half of 2012.
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