Coronado Biosciences Receives Orphan-Drug Designation From FDA for CNDO-109-Activated Allogeneic Natural Killer Cells for the Treatment of AML

Coronado Biosciences, Inc.

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.