Texas Reveals Positive Ph III Novastan Data

Texas Biotechnology has reported positive data from a Phase III trial,entitled ARG-310, with Novastan (argatroban), its thrombin inhibitor for acute coronary intervention in patients with a history of heparin-induced thrombocytopenia.

All 30 patients enrolled in the trial, including those undergoing percutaneous transluminal coronary angioplasty, direct atherectomy, or stent placement, successfully completed the procedure while using Novastan as the anticoagulant, reports the company. It adds that only one patient experienced clinically-significant bleeding. Texas says it expects to use these interventional data as a supplement to its initial New Drug Application for non-interventional patients.

Meanwhile, Texas is investigating the use of Novastan as an adjunct to thrombolytics in acute myocardial infarction, and has begun Phase I trials with its selectin antagonist for asthma (TBC 1269), as well as its endothelin-A receptor antagonist for congestive heart failure (TBC 11251).