Savient is conducting phase 3 clinical studies with Puricase(R) (PEG-uricase) in symptomatic gout patients who cannot benefit from conventional therapies. There is currently no available treatment option for this subset of gout patients. The Phase 3 program is designed to compare the safety and efficacy of Puricase (PEG-uricase) administered by two-hour intravenous infusion every two weeks or every four weeks versus placebo infusion, over a six-month period. Eligible patients must have hyperuricemia and symptomatic gout, and have been unresponsive to or intolerant of conventional therapy. All patients who complete the placebo-controlled trials will be invited to participate in a long-term open label extension.
Efficacy endpoints will include the level of uric acid control, an assessment of the reduction in burden of gout tophi using digital photography, reduction in the frequency of gout flares, improvement in the count of swollen and tender joints, and improvements in patient reported outcomes using the Short Form 36 (SF-36) and the Health Assessment Questionnaire-Disability Index (HAQ-DI).
Savient licensed exclusive, worldwide rights to the technologies related to Puricase (PEG-uricase) from Duke University (Duke) of North Carolina and Mountain View Pharmaceuticals, Inc. (MVP), a California corporation. Duke developed the recombinant porcine uricase enzyme and MVP developed the PEGylation technology. MVP and Duke were granted U.S. and foreign patents covering the licensed technology. Puricase is a registered trademark of Mountain View Pharmaceuticals, Inc.
詳細資料請見：http://blog.pixnet.net/mulicia/post/4368632
Efficacy endpoints will include the level of uric acid control, an assessment of the reduction in burden of gout tophi using digital photography, reduction in the frequency of gout flares, improvement in the count of swollen and tender joints, and improvements in patient reported outcomes using the Short Form 36 (SF-36) and the Health Assessment Questionnaire-Disability Index (HAQ-DI).
Savient licensed exclusive, worldwide rights to the technologies related to Puricase (PEG-uricase) from Duke University (Duke) of North Carolina and Mountain View Pharmaceuticals, Inc. (MVP), a California corporation. Duke developed the recombinant porcine uricase enzyme and MVP developed the PEGylation technology. MVP and Duke were granted U.S. and foreign patents covering the licensed technology. Puricase is a registered trademark of Mountain View Pharmaceuticals, Inc.
詳細資料請見：http://blog.pixnet.net/mulicia/post/4368632
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