Savient begins patient dosing in phase 3 studies of Puricase for gout

By Lisa Kerner

Charlotte, N.C., June 14 - Savient Pharmaceuticals, Inc. said it has dosed the first patient in its phase 3 clinical studies of Puricase (PEG-uricase) for the treatment of gout.

The two replicate phase 3 clinical studies (Gout 1 and Gout 2) are designed to compare the safety and efficacy of Puricase administered intravenously for two hours every two weeks or every four weeks versus a placebo. Each six-month study will randomize about 100 patients.

"The two gout studies now underway at approximately 60 clinical sites in the United States, Mexico and Canada incorporate an innovative design and novel methodologies to demonstrate both uric acid control and attainment of clinical outcomes," chief medical officer Zeb Horowitz said in a company news release.

Gout, caused by deposits of uric acid crystals in connective tissues and joints, affects about 5 million Americans, according to the National Institutes of Health.

Puricase, a chemically modified form of recombinant uricase, is being developed for individuals with symptomatic gout who cannot be treated adequately using conventional therapies.

Savient is an emerging specialty pharmaceutical company based in East Brunswick, N.J.

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