ZymoGenetics rhThrombin
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
A Phase III pivotal trial for ZymoGenetics' recombinant human thrombin is expected to begin in the second half of 2005, the company says Feb. 9. Positive results from four Phase II studies of the topical hemostat were recently released. There was no evidence of antibody formation in the 130 patients, a problem seen with other thrombin products, the firm notes. ZymoGenetics is highlighting rhThrombin's "low potential for antigenicity and negligible risk of viral transmission." The firm is preparing for an end-of-Phase II meeting with FDA...