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Enrollment underway in Protalix Bio's mid-stage study of ulcerative colitis candidate OPRX-106; top-line data expected in H2 2017

Nov. 30, 2016 8:36 AM ETProtalix BioTherapeutics, Inc. (PLX) StockBy: Douglas W. House, SA News Editor
  • The first patient has been enrolled in Protalix BioTherapeutics' (NYSE:PLX) Phase 2 clinical trial assessing OPRX-106 in ulcerative colitis (UC). Initial data should be available in the second half of next year.
  • The open-label two-arm study will enroll 20 subjects with mild-to-moderate UC. Participants will be randomized to receive a daily oral dose of either 2 mg or 8 mg of OPRX-106 for eight weeks. The primary endpoint is safety. Secondary endpoints include clinical response.
  • If successful, OPRX-106 will be the first oral enzyme treatment for UC. It is a plant-expressed recombinant human tumor necrosis factor receptor II fused to an IgG1 Fc domain. It is based on the company's ProCellEx platform.

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