Subcutaneous Cinryze: Phase IIb started

ViroPharm began a double-blind, crossover, international Phase IIb trial to evaluate subcutaneous Cinryze in combination with Halozyme's recombinant human PH20 hyaluronidase ( rHuPH20) for 8 weeks in about 40 adolescent and adult patients. Patients will receive 1,000 units subcutaneous Cinryze plus 24,000 units rHuPH20 twice weekly and 2,000 units Cinryze plus 48,000 units rHuPH20 twice weekly.

In September, FDA lifted a clinical hold for subcutaneous Cinryze in combination rHuPH20 for HAE. FDA placed the clinical hold after raising concerns in a complete response letter for a BLA for subcutaneous HyQ from Halozyme's partner Baxter International Inc. (NYSE:BAX, Deerfield, Ill.) to treat primary immunodeficiency disorder (PID). FDA had concerns about non-neutralizing antibodies generated against rHuPH20, which is a component in HyQ along with IV Gammagard, an IgG antibodies plasma-based therapy (see BioCentury, Aug. 6 & Sept. 24). ...