Abraxis BioScience, Inc. has initiated enrollment in its Phase II clinical trial to evaluate the efficacy and safety of Coroxane for the prevention and reduction of restenosis following revascularization of the superficial femoral artery (SFA).

Coroxane (nanometer-sized paclitaxel and Abraxane) is a novel, solvent-free, albumin-bound form of paclitaxel used for cardiovascular applications. Abraxane is the first and only approved protein-bound, nanometer-sized, solvent-free taxane and is the first commercial product to validate Abraxis’ proprietary nab technology platform. Abraxane is marketed for the treatment of breast cancer.

Earlier preclinical and clinical studies investigated the potential for Coroxane as an alternative to drug eluting stents in coronary arteries. Patrick Soon-Shiong, M.D., chairman and chief executive officer of Abraxis,  noted that the company currently intends to seek a strategic partner for the development and marketing of Coroxane.

Tthe Phase II trial, led by principal investigator John Rundback, M.D., director of the Interventional Institute at Holy Name Hospital in Teaneck, N.J. and Associate Professor of Clinical Radiology at Columbia University College of Physicians and Surgeons, is a randomized, open-label, prospective, multicenter study that will compare the safety and efficacy of three different Coroxane dosing schedules to primary percutaneous balloon angioplasty with provisional stenting, the standard treatment for stenosis in the SFA.

“The present study is an important step forward in providing a treatment alternative to patients with moderate to long segment SFA disease using Coroxane. The novel mode of delivery allows platform independent treatment and can be used regardless of the initial revascularization method,” said Dr. Rundback. “Since drug eluting stents have not yet clearly shown long-term benefit, a different strategy for delivering this very bioactive agent to the site of balloon injury has tremendous potential to expand the therapeutic options and improve outcomes for these patients.”

Approximately 150 patients will be monitored for restenosis of the target vessel at nine months as evaluated by angiography and duplex ultrasound.