American Bioscience Presents Results of First Human Study of Coroxane
American BioScience presented data at the recent Cardiovascular Revascularization Therapies Conference in Washington, D.C., on the SNAPIST-I trial (Systemic Nanoparticle Paclitaxel for Treatment of In-Stent Restenosis) investigating the use of its protein-engineered nanoparticle albumin bound paclitaxel (Coroxane) for the treatment of restenosis following bare-metal stenting of coronary arteries.
The study was designed as an initial safety and dose-finding study to determine the appropriate schedule for Coroxane in patients with de novo lesions in native coronary arteries.
In the completed Phase I study, 23 patients were randomized to one of four dose groups ranging from 10-100 mg/m2, and were administered Coroxane intravenously immediately following the stenting procedure. It was determined that patients receiving less than 70 mg/m2 were free of any significant adverse events related to the drug.
While the study was not designed to compare efficacy between dose groups, the study appeared to show some trends in efficacy by angiographic follow-up at six months for those patients receiving 30 and 70 mg/m2 of Coroxane. Further clinical studies to determine efficacy of Coroxane in coronary restenosis are in progress, and with ongoing development, the company will explore a global partner for this product.