BioCentury
ARTICLE | Clinical News

ViroPharma discontinuing trial for subcutaneous Cinryze/rHuPH20

August 2, 2013 12:41 AM UTC

Halozyme Therapeutics Inc. (NASDAQ:HALO) slipped $1.19 (14%) to $7.32 on Thursday after ViroPharma Inc. (NASDAQ:VPHM) said it is discontinuing a Phase IIb trial evaluating subcutaneous Cinryze in combination with Halozyme's recombinant human PH20 hyaluronidase ( rHuPH20) for hereditary angioedema (HAE). ViroPharma said there was an "unexpected incidence and titer of non-neutralizing anti-rHuPH20 antibodies." Last September, FDA lifted a clinical hold on the product. The agency had placed the hold due to concerns about non-neutralizing antibodies against rHuPH20 that were raised by a complete response letter for a different product that uses Halozyme's rHuPH20 drug delivery technology (see BioCentury Extra, Sept. 21, 2012).

ViroPharma said it has developed a low-volume subcutaneous formulation of Cinryze that does not contain rHuPH20. The company plans to start a Phase III trial with the alternative formulation next year, the same timeframe it expected for the Cinryze/rHuPH20 combination. Cinryze is approved in the U.S. and EU as an IV formulation. ...