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news.CSL Behring has started enrolling patients in its Phase II/III clinical trial of its recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP) for on-demand treatment in patients with congenital hemophilia A or B.
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Around 54 male patients will be enrolled in the trial, which is designed to evaluate the pharmacokinetics (PK), efficacy, and safety of rVIIa-FP in these patients who have developed an inhibitor to factor VIII or factor IX replacement therapy.
Preclinical trials have showed that rVIIa-FP (CSL689) has favorable pharmacokinetic properties compared with the existing recombinant FVIIa product.
CSL Limited R&D director and chief scientific officer Dr Andrew Cuthbertson said: "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.
"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."
In a phase I trial in healthy volunteers, rVIIa-FP showed a good tolerance, and a three- to four-fold increase in half-life compared with the commercially available rFVIIa-product (median 8.5h).