-- 200-Subject Trial of Novel Cell Therapy AC607 at leading tertiary care centers in the United States --
AlloCure Begins Phase 2 Clinical Trial in Acute Kidney Injury
AlloCureJohn Wirthlin, 801-583-8450Chief Operating OfficerorKureczka/Martin AssociatesJoan Kureczka, 415-821 2413
AlloCure, Inc. today 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, M.D., 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, M.D., 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.”
AC607 is a novel biologic therapy under development for the treatment of AKI. AC607 also possesses potential applications in other grievous illnesses. 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 powerful 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 host’s immune system, enabling administration in an “off the shelf” paradigm without the need for blood or tissue typing.
AlloCure, Inc. is a privately held, clinical-stage biotechnology company focused on the treatment of kidney disease. The company is a leader in the AKI field and is pioneering the development of the first effective therapy for the treatment of AKI. The company’s headquarters is located in Burlington, MA. For more information about AlloCure, please visit the company’s web site at .