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Aug 06, 2012
 |  BC Week In Review  |  Clinical News  |  Clinical Status

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...

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