CSL Doses First Inhibitor Patients in Trial of New rFVII Product
Last month CSL Behring announced the first human dosing of the company’s recombinant fusion protein, which links coagulation factor VIIa with albumin (rVIIa-FP). The purpose of the Phase I study is to measure the safety and pharmacokinetics of rVIIa-FP in healthy volunteers in comparison to placebo. CSL Behring, in collaboration with its parent company CSL Limited, is developing rVIIa-FP to treat hemophilia A and hemophilia B patients who have inhibitors as part of the PROLONG 7- FP clinical study program. CSL Behring’s albumin fusion technology uses albumin as the “ideal recombinant genetic fusion partner” for factor proteins because of its long half-life, high potential for tolerability, known mechanism of clearance and lower risk for inhibitor response.
CSL Behring’s rVIIa-FP was previously granted Orphan Drug Designation by the European Commission and the U.S. Food and Drug Administration (FDA). The FDA’s Office of Orphan Products Development grants orphan drug status, which means the drugs go through an expedited review process. The designation allows for accelerated approval, so that much-needed drugs or biologics become available to patients with rare, life-threatening diseases who need effective treatments. More information about this and other studies can be found at www.clinicaltrials.gov.
Source: CSL Behring news release dated March 29, 2012