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Protalex Inc announces interim findings from U.S. Phase 1(b) trial of PRTX-100 in active rheumatoid arthritis patients


Monday, 10 Feb 2014 06:00am EST 

Protalex Inc:Says preliminary findings from a limited interim analysis of its U.S.-based multicenter Phase 1(b) randomized, multiple-dose, dose-escalation study of PRTX-100 in combination with methotrexate or leflunomide in adults with active rheumatoid arthritis (PRTX-100-104 Study).PRTX-100 is an investigational drug incorporating a purified form of Staphylococcal Protein A.The interim analysis included patients in the first four dosing cohorts of the five-cohort study through day 85 of the study protocol.Five U.S. clinical centers enrolled 41 patients in Cohorts 1 through 4 of the 104 Study and five patients discontinued from the study prior to their day 85 visit.A preliminary interim analysis of Cohorts 1 through 4 indicated that PRTX-100 was generally safe and well tolerated.The rate of adverse events (AEs) among patients receiving PRTX-100 was comparable to that of those receiving placebo and similar to that seen in prior clinical studies of PRTX-100.Two patients discontinued the study because of treatment-related AEs. 

Company Quote

4.0
-1.5 -27.27%
19 Dec 2014