Recombinant Factor IX Begins Clinical Trial

Genetics Institute has begun clinical studies in the USA of its recombinant human Factor IX (rhFIX) in the treatment of hemophilia B. Genetics Institute's product is the first recombinant Factor IX to enter clinical trials.

The initial study planned by the company is a blinded cross-over trial in 12 patients with hemophilia to be conducted at three centers within the USA. The study will evaluate patient response to the recombinant product compared to a currently-licensed plasma-derived Factor IX.

Dennis Harp, a spokesman for the firm, told the Marketletter that as the product is still in early-stage development, the cost of production is not yet known. However, he added, the refining of the manufacturing process should enable it to be produced at a cost comparable to plasma-derived Factor IX. The ability of the company to produce the substance at a similar cost should encourage a wide uptake if it is clinically equivalent to the plasma-derived substances available. This stems from its main advantage of guaranteed protection from viral contamination.