Drug Coated Balloon Test has Promising Results

Vascular Nanotransfer Technologies’ (VNT) large animal model in vivo tests of its paclitaxel (a mitotic inhibitor used in cancer chemotherapy) nanocarrier-based drug-coated balloon (DCB) have achieved tissue levels comparable to devices with proven clinical efficacy, the company claims.

“VNT has achieved tissue levels of paclitaxel that are comparable to devices with proven clinical efficacy but has done so with a device that has superior coating characteristics along with a lower concentration of paclitaxel per surface area,” said VNT’s recently appointed President and CEO John A. Williams. “We are very pleased with our proprietary balloon coating technology designed for enhanced drug delivery and superior coating characteristics. Now we have a high-performing paclitaxel nanocarrier based DCB with strong in vivo test results.”

VNT is focused on DCBs, which are emerging as the ideal therapeutic tool for patients with coronary in-stent restenosis and peripheral vascular disease. However, despite the success of first-generation DCBs in clinical trials, they exhibit significant limitations related to the precision in drug delivery and tissue retention, raising concerns about overall vascular safety. There is a need for the development of reliable coatings that allow for controlled drug delivery at a lower dose and minimal dislodgement of the coating into the distal vessel.

“There are as yet no drug coated balloons approved for sale in the United States,” said Williams. “VNT’s paclitaxel-based DCB for coronary and peripheral vascular applications is designed to have important competitive advantages over today’s European DCB market leaders, such as lower balloon drug surface concentration and particulate counts. We expect to begin patient enrollment for VNT’s first-in-man clinical trial in early 2013.”

Auburndale, Mass.-based Vascular Nanotransfer Technologies develops drug-coated balloon for vascular atherosclerosis as well as non-vascular applications.