Octapharma Clinical Trial Begins in the U.S. and Germany Treating Hemophilia A Patients with First Recombinant Factor VIII Derived from a Human Cell-Line
HOBOKEN, N.J., Nov. 1, 2010 /PRNewswire/ -- Octapharma AG, one of the largest human protein products manufacturers in the world, and Octapharma USA today announced that patients diagnosed with severe hemophilia A have started treatment in a multi-center study that is researching the use of the first recombinant Factor VIII (rFVIII) derived from a human cell line (Human-cl rhFVIII). Researchers are investigating Human-cl rhFVIII, to assess pharmacokinetics, efficacy, safety and immunogenicity for previously treated patients with severe hemophilia A.
The National Institutes of Health estimate that 90 percent of all hemophilia patients have hemophilia A, also known as Factor VIII deficiency, and 70 percent of those have the severe form of the illness.
The prospective, randomized, actively controlled, open label Phase 2 trial is being held at research centers in the US and Germany under the title "Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of human-cl rhFVIII, a Newly Developed Human Cell-Line Derived Recombinant FVIII Concentrate in Previously Treated Patients with Severe Hemophilia A." The study started in spring 2010 and patient enrollment is well underway. Please visit www.clinicaltrials.gov for details.
Human-cl rhFVIII is a fourth-generation recombinant factor VIII (rFVIII) concentrate developed by Octapharma for the control and prevention of bleeding episodes and for surgical prophylaxis in patients with hemophilia A. Human-cl rhFVIII is produced in genetically modified Human Embryonic Kidney (HEK) 293F cells. Human-cl rhFVIII is currently the only rFVIII, which has a human glycosylation pattern. Today, the development of antibodies against in