BURLINGTON, Mass.—The U.S. Food and Drug Administration (FDA) has granted fast-track designation to Allocure Inc.’s AC607, which is an investigational treatment for acute kidney injury (AKI).
The FDA’s Fast Track program is designed to facilitate development and expedite the review of new therapeutics that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
AC607 comprises allogeneic bone marrow-derived mesenchymal stem cells that are harvested from healthy adult donors and then expanded via a mature and state-of-the art 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. Following the completion of a successful Phase 1 trial, which was presented in November 2011 at the annual meeting of the American Society of Nephrology, AlloCure plans to initiate a Phase 2 study of AC607 in the first half of 2012.
“The positive results from our Phase 1 trial of AC607, which 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, demonstrate the potential of this novel therapy to offer the first effective treatment for AKI," said Robert M. Brenner, MD, AlloCure president and CEOr. “The Fast Track designation recognizes the unmet and high therapeutic need in AKI, which can result in extended hospitalization, the need for dialysis, and death."