US-based firm Mercator MedSystems has started patient enrolment for the Phase II TANGO clinical trial of its Bullfrog micro-infusion device in critical limb ischemia (CLI) patients.
Bullfrog is designed to directly, non-systemically and safely infuse therapeutic and diagnostic agents into adventitial tissues surrounding the blood vessels.
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The prospective, multi-centre, randomised, dose-escalation TANGO trial will investigate the effects of Bullfrog during adventitial delivery of Pfizer's drug Torisel, otherwise known as temsirolimus, following revascularisation of lesions below the knee (BTK) in CLI patients.
The trial will involve up to 60 patients, who will be administered with Torisel after the obstructions are opened using balloon angioplasty or mechanical atherectomy.
TANGO trial is being funded by the National Heart, Lung and Blood Institute (NHLBI), and will be conducted at approximately 150 US centres.
Mercator chief executive officer Trent Reutiman said: "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 using the Bullfrog in superficial and femoropopliteal arteries, where an anti-inflammatory steroid, dexamethasone, was used.
"The data has laid the groundwork for the expansion of our clinical development programme and the start of TANGO, which complements our ongoing LIMBO BTK trials and an ongoing BTK trial being conducted by another biopharma company."
The Bullfrog device is being studied further to treat inflammation or decrease elastic recoil, and also as an intravascular drug delivery technology in a single US BTK study.
