Octapharma initiates Human-cl rhFVIII Phase 2 trial

Human-cl rhFVIII is a 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, a randomised, actively controlled, open label, multicenter Phase 2 trial is being conducted 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.’

During a previous first single-center clinical study, Human-cl rhFVIII demonstrated its safety and efficacy in 22 PTPs without causing any inhibitors or non-inhibitory antibodies against Human-cl rhFVIII.

Octapharma said that the Human-cl rhFVIII is concentrated and purified for virus inactivation/removal by solvent detergent and nanofiltration although the cell bank and end of production cells have been extensively tested to ensure they are free of any endogenous or infectious viruses.