Fast Track Designation for AC607 for Acute Kidney Injury

AlloCure announced that the FDA has granted fast track designation for AC607 for the treatment of acute kidney injury (AKI). Positive results from the Phase 1 trial of AC607 showed an excellent safety profile and suggested an ability to reduce both the incidence of AKI and hospital length of stay in cardiac surgery patients. AlloCure plans to initiate a Phase 2 study of AC607 in the first half of 2012.

AC607 comprises allogeneic bone marrow-derived mesenchymal stem cells that are harvested from healthy adult donors and then expanded via a manufacturing process. AC607 homes to the site of injury where it mediates anti-inflammatory and organ-repair processes via the secretion of beneficial paracrine factors, without differentiation and repopulation of the injured kidney. Importantly, AC607 avoids recognition by the immune system, enabling administration in an “off the shelf” paradigm without the need for blood or tissue typing.

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