First U.S. Trial to Assess Delivery of a -Limus Agent to Prevent BTK Restenosis
EMERYVILLE, CA., April 26, 2017 - Mercator MedSystems, Inc., a medical technology company, announced today the first patient enrollment into the TANGO (Temsirolimus Adventitial Delivery to Improve Angiographic Outcomes Below the Knee) clinical trial. TANGO will study the effects of using Mercator’s proprietary Bullfrog® Micro-Infusion Device for the adventitial delivery of the drug TORISEL® (temsirolimus) after revascularization of lesions below the knee (BTK) in patients with critical limb ischemia (CLI).
TANGO is the fourth clinical trial ongoing with the Bullfrog device in BTK (the third in the U.S.), further broadening Mercator’s portfolio of targeted drug delivery for peripheral artery disease. While other trials with the Bullfrog device are examining anti-inflammation or reduction of elastic recoil, temsirolimus reduces cellular proliferation to limit restenosis. Outside of trials using the Bullfrog device for drug delivery, only one intravascular drug delivery technology (a paclitaxel-coated angioplasty balloon) is being investigated in a single U.S. BTK study.
“This is the first 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.,” said Dr. Ian Cawich, principal investigator for TANGO and an interventional cardiologist at the Arkansas Heart Hospital. “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.”
TANGO is a prospective, multi-center, randomized, dose-escalation trial recruiting approximately 60 patients who have CLI related to arterial obstructions in BTK arteries. In these patients, TORISEL will be delivered into the tissue immediately around the arterial wall after balloon angioplasty or mechanical atherectomy is used to open the obstructions. TORISEL, a Pfizer drug, belongs to a family of well-known agents (the -limus analogs) that are commonly delivered by coronary drug eluting stents following revascularization of lesions. The use of Mercator’s Bullfrog delivery system in the TANGO study allows the local delivery of this agent in BTK lesions, but eliminates the need to leave behind an implant in the body. While the small and tortuous anatomy of the BTK vessels can make navigation and drug delivery from a coated balloon difficult, the small profile of the Bullfrog device allows it to adjust well to small vessels and it is able to deliver drug volumes that are independent of vessel size.
“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,” said Trent Reutiman, CEO of Mercator. “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.”
Approximately 2 million people in the U.S. are living with CLI. Revascularization is widely regarded as the cornerstone of treatment. However, restenosis – or the recurrence of the narrowing of the vessel – after treatment of long and complex arterial obstructions BTK has been reported to occur up to 75% of the time within 3 months of the initial revascularization. If not resolved, CLI can lead to the need for amputations of the toes, foot or lower leg.
About the Bullfrog® Micro-Infusion Device:
The Mercator Bullfrog Micro-Infusion Device is a FDA 510(k)-cleared and CE-Marked system that infuses therapeutic and diagnostic agents directly, non-systemically, and safely through blood vessel walls into adventitial tissues. The closed balloon provides a protective covering for a tiny, perpendicular-oriented injection microneedle as it is guided safely through the vascular system to target vessels with diameters of 2 to 8 millimeters.
The Temsirolimus Adventitial Delivery to Improve Angiographic Outcomes Below the Knee (TANGO) trial is a Phase 2, perivascular drug delivery trial that pairs the Bullfrog® Micro-Infusion Device with TORISEL® (temsirolimus) to treat below-the-knee arteries after revascularization. TANGO is being conducted in up to 15 centers in the U.S. Its national principal investigator is Ian Cawich, MD, from the Arkansas Heart Hospital in Little Rock, Arkansas. The TANGO study was approved by the U.S. Food and Drug Administration (FDA) under an Investigational New Drug (IND) application. The trial is being funded by The National Heart, Lung, and Blood Institute (NHLBI), a part of the National Institutes of Health (NIH) under Award Number R44HL102998. More information about the TANGO trial is available at https://clinicaltrials.gov/ct2/show/NCT02908035.
Mercator MedSystems, Inc. (www.mercatormed.com), based in Emeryville, CA, is a venture-backed, privately held medical technology company. The company develops proprietary catheter-guided micro-infusion systems for targeted delivery of drugs and biologics deep inside the body to treat the root cause of a growing portfolio of medical conditions, including peripheral disease, cardiovascular disease, cancer, hypertension and heart disease.