BioCentury
ARTICLE | Clinical News

Subcutaneous Cinryze: Phase II resumed

September 24, 2012 7:00 AM UTC

Halozyme and partner ViroPharma said FDA lifted a clinical hold on a Phase II trial of subcutaneous Cinryze in combination with Halozyme's recombinant human PH20 hyaluronidase ( rHuPH20) for HAE. The partners said they can restart the Phase II trial after they submit a revised protocol to allow for increased monitoring of rHuPH20 antibody levels. FDA also requested the partners inform FDA of elevated antibody levels during treatment.

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). According to the partners, the agency said it believes the concerns about the antibodies are limited to subcutaneous HyQ. ...