The US Food and Drug Administration has given its approval for Ablative Solutions to begin phase II trial of combination drug/device therapy for hypertension.
Ablative Solutions’ investigational new drug (IND) application for the Peregrine System kit for catheter-based renal denervation is targeted to deliver alcohol to treat uncontrolled hypertension.
The company plans to conduct multi-centre, double-blind, randomised, sham-controlled trial to evaluate the drug-device combination therapy in treating persistent hypertension in spite of regular medical treatment and in conjunction with medications for antihypertensive.
The Peregrine system kit will have a specific formulation of dehydrated alcohol which will be infused into the targeted area surrounding the renal artery using the system’s infusion catheter.
The infusion catheter has a general 510(k) clearance in US in delivering therapeutic and diagnostic agents to the perivascular space surrounding the peripheral arteries.
The trial, which will be known as TARGET-BP I, will start in the US and globally. It will enrol about 100 patients in 20 global centres.
The company claims that the principal investigators of the study are experienced leaders in treating hypertension and have been in leadership roles investigating renal denervation as therapy for hypertension.
SUNY Downstate College of Medicine professor of medicine & associate dean of research Michael Weber said: "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.
"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."
The trial will include the delivery of Peregrine system infusion catheter by using a minimally invasive technique through a small access site in the femoral artery.
n the renal artery, microneedles will be employed in a proprietary deployment system. This will access the area outside renal artery and deliver the dehydrated alcohol directly to the nerve tissue.
Ablative Solutions president and COO Vartan Ghazarossian said: "We are privileged and honored to be working with thought leaders in the field of hypertension management and renal denervation.
“We believe that a combination drug-device approach to deliver targeted chemical denervation may indeed provide a therapy that can help those patients whose hypertension is poorly controlled with medication alone.
“We hope to demonstrate through our clinical trials that perivascular chemical renal denervation using dehydrated alcohol gives physicians and the patients a minimally invasive approach that consistently delivers the desired therapeutic effect."