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Protalex, Inc. (PRTX) Announces Preliminary Unblinded Findings From Cohorts 1-4 Of U.S. Phase 1b Trial Of PRTX-100 In Active Rheumatoid Arthritis Patients


6/3/2014 9:34:36 AM

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FLORHAM PARK, N.J.--(BUSINESS WIRE)--Protalex, Inc. (OTCQB:PRTX), a clinical-stage biopharmaceutical company, today announced it has completed analysis of certain key parameters from its U.S.-based multicenter Phase 1b randomized, multiple-dose, dose-escalation study of PRTX-100 in combination with methotrexate or leflunomide in adults with active rheumatoid arthritis (RA) (PRTX-100-104 Study). The primary endpoint of the study is to assess safety and tolerability, with secondary objectives to examine the effects of PRTX-100 on measures of disease activity, assessing the immunogenicity and evaluating the pharmacokinetic (PK) parameters after repeated doses, and determining possible relationships between the immunogenicity of PRTX-100 and safety, PK and efficacy parameters.

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