BURLINGTON, Mass.—AlloCure, Inc. announced that it has initiated a phase 2 clinical trial of AC607, the company's mesenchymal stem cell therapy, as a potential treatment for acute kidney injury (AKI).
The randomized, double-blind, placebo-controlled, multi-center trial, designated ACT-AKI (AC607 Trial in Acute Kidney Injury) (NCT01602328), will enroll 200 cardiac surgery subjects at leading tertiary care centers in the United States.
"ACT-AKI follows the positive results from a phase 1 AC607 trial in cardiac surgery subjects, which showed an excellent safety profile and encouraging data on the incidence of AKI and hospital length of stay," said Robert M. Brenner, MD, AlloCure president and chief executive officer. "We have worked closely with leaders in the field on the design of ACT-AKI, and trial initiation represents an important milestone for AlloCure and the patients we collectively serve."
"AC607 is a promising therapeutic candidate for AKI, for which effective therapies are greatly needed," said Richard J. Glassock, MD, emeritus professor of medicine at the Geffen School of Medicine at the University of California, Los Angeles. "The initiation of ACT-AKI represents a critical step in the development of an innovative therapy for this all-too-common, serious and costly medical condition, for which no approved treatments currently exist beyond supportive care."