Phase 2 Trial for Ablative Solutions' Combination Drug/Device Therapy for Hypertension Initiated

September 13, 2016 - Medical Product Outsourcing Magazine

MAF-1 portfolio company Ablative Solution announced today that the U.S. Food and Drug Administration (FDA) has allowed the company's Investigational New Drug (IND) application for the Peregrine System Kit for catheter-based renal denervation, with targeted delivery of alcohol, for the treatment of uncontrolled hypertension to proceed. Under the IND, Ablative Solutions plans to conduct a multi-center, double-blind, randomized, sham-controlled trial to evaluate its drug-device combination therapy for the treatment of persistent hypertension despite optimal medical treatment, in conjunction with antihypertensive medical therapy.

The trial, called TARGET-BP I, will begin in the United States and will enroll approximately 100 patients in approximately 20 centers globally. The investigational Peregrine System Kit for the treatment of uncontrolled hypertension incorporates a specific formulation of dehydrated alcohol that is infused into the targeted area surrounding the renal artery using the Peregrine System Infusion Catheter, which has a general 510(k) clearance in the U.S. for delivery of therapeutic and diagnostic agents to the perivascular space surrounding peripheral arteries.  

The principal investigators  of the study are experienced thought leaders in the treatment of hypertension and include Michael Weber, MD, Professor of Medicine & Associate Dean of Research, SUNY Downstate College of Medicine, Brooklyn, New York, and David Kandzari, MD, Director and Chief Scientific Officer, Piedmont Heart Institute in Atlanta, Georgia. The European Co-PIs are Felix Mahfoud, MD, Director of Special Hypertension Clinic, University Hospital of Saarland, Germany, and Atul Pathak, MD, Professor of Cardiology/Pharmacology, Clinique Pasteur, Toulouse, France.

"The mechanism for the use of targeted chemical denervation makes sense to me because I believe it has the potential to effectively reduce the over-signaling of the renal nerves that can contribute to hypertension," commented Michael Weber, MD. "The Company has received approval from the FDA to conduct a trial that studies the safety and efficacy of an intervention designed to address challenges that physicians face in managing patients with hypertension. The carefully considered trial protocol and the innovative catheter-based therapeutic delivery being studied in TARGET-BP I will attract considerable attention among the experts and practitioners who work in the field of hypertension." more