Mercator MedSystems said today that the 1st patient was enrolled in its Tango clinical trial. The trial is evaluating Mercator’s Bullfrog micro-infusion device for the adventitial delivery of temsirolimus below the knee in patients with critical limb ischemia.
The Tango trial is the 4th ongoing clinical trial using the Bullfrog device in below the knee applications for patients with peripheral artery disease. Mercator said that outside of trials using its Bullfrog drug delivery system, there is only 1 other intravascular drug delivery tech, a paclitaxel-coated angioplasty balloon, being investigated in a U.S. study for BTK vascular disease.
“This is the 1st clinical trial of its kind. While studies have been done outside the U.S. with -limus-eluting stents in focal lesions in the legs, the local delivery of a -limus agent without a permanent implant and in lesions longer than 5 centimeters (2 inches) has not yet been studied in the U.S.,” principal investigator Dr. Ian Cawich said in prepared remarks. “We are thrilled to be a part of the TANGO study and to be at the forefront of utilizing this novel approach to address the tremendous medical need for an effective CLI treatment.”
The trial is slated to enroll 60 patients with critical limb ischemia related to arterial obstructions in arteries below the knee. Researchers plan to use the Bullfrog device to deliver Pfizer‘s (NYSE:PFE) Torisel to the tissue surrounding the arterial wall after balloon angioplasty or mechanical atherectomy. Torisel is traditionally delivered using a drug-eluting stent.
Mercator said that its Bullfrog delivery system enables the local delivery of Torisel in BTK lesions, but eliminates the need for a permanent implant. The company added that the small profile of its device adjusts well in small vessels that coated-balloons can have difficulty navigating.
“The team at Mercator is developing a profoundly different approach to local vascular drug delivery with a micro-infusion platform. We are encouraged by our existing lower extremity data with the Bullfrog in superficial and femoropopliteal arteries, where an anti-inflammatory steroid, dexamethasone, was used,” CEO Trent Reutiman said. “Those data have laid the groundwork for expansion of our clinical development program and the start of Tango, which complements our ongoing Limbo BTK trials and an ongoing BTK trial being conducted by another biopharma company. Mercator is now the only company developing multiple drug solutions targeting different aspects of the restenosis cascade in CLI patients in the U.S.”