Subcutaneous Cinryze: Phase II hold

Halozyme said that FDA concerns about non-neutralizing antibodies generated against Halozyme's recombinant human PH20 hyaluronidase ( rHuPH20) caused FDA to place a clinical hold on a Phase II trial of a combination of rHuPH20 and subcutaneous Cinryze from partner ViroPharma for HAE. According to ViroPharma, FDA said the issues are not specific to Cinryze and the company could evaluate subcutaneous Cinryze without rHuPH20. ViroPharma said it will also voluntarily defer enrollment at the EU sites of the trial. The company is preparing a Phase II trial of subcutaneous Cinryze without rHuPH20, for which ViroPharma received IND and protocol clearance from FDA in 2011. The company markets Cinryze, an IV C1 esterase inhibitor, in the EU for the treatment and for pre-procedure and routine prevention of angioedema attacks in HAE patients ages >=6 years, and in the U.S. for routine prophylaxis of acute attacks of HAE. Last year, Halozyme granted ViroPharma exclusive, worldwide rights to use its Enhanze rHuPH20 drug delivery technology to develop a subcutaneous formulation of Cinryze (see BioCentury, May 16, 2011). ...