CSL Behring announced today that the first patient has been enrolled in its Phase II/III clinical study evaluating the pharmacokinetics (PK), efficacy, and safety of the company's recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP) for on-demand treatment in patients with congenital hemophilia A or B who have developed an inhibitor to factor VIII or factor IX replacement therapy. The study will enroll approximately 54 male patients, the first of whom was enrolled in Malaysia.
"CSL Behring has a thorough understanding of the bleeding disorders community, focused scientific expertise and a strong commitment to developing and delivering innovative specialty biotherapies that treat serious medical conditions," said Dr. Andrew Cuthbertson, Chief Scientific Officer and Director of R&D, CSL Limited. "Our commitment, expertise and understanding helped CSL to develop rVIIa-FP, based on the innovative recombinant albumin fusion technology platform, to treat patients with hemophilia A or B with inhibitors as well as congenital factor VII deficiency."
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