Green Cross Initiates Phase III Trial of rFVIII Product
Green Cross Corporation (GCC), a Yongin, Korea-based pharmaceutical company specializing in plasma-derived and recombinant products for the treatment of rare and chronic conditions, recently announced the initiation of a phase III clinical study. The purpose of the international trial, which is currently enrolling patients, is to assess the safety, efficacy and pharmacokinetics ofGreenGene™ F, the company’s investigational recombinant factor VIII (rFVIII) therapy.
The multicenter study will gauge the efficacy of GreenGene™ F when used both prophylactically to prevent bleeding and on-demand to treat acute bleeds. Subjects will be monitored for inhibitor development for at least 50 exposure days after the therapy begins.
“Green Cross is committed to the highest standards of safety and purity. As such, we are very pleased to be conducting this clinical trial, with the hopes of providing more treatment solutions to healthcare providers and severe hemophilia patients in the United States,” said Chang-Hee Lee, MD, Head of the Medical Division at GCC.
Trial investigators are recruiting patients 12 years of age or older with severe hemophilia A previously treated with a factor VIII (FVIII) product, but without the presence or history of inhibitors to FVIII. To learn more about eligibility and for updates on this trial and other clinical studies, go to: www.clinicaltrials.gov, a service of the U.S. National Institutes of Health.
Source: Green Cross Corporation, January 2013