PRTX-100: Additional Phase Ib data

Additional data from 61 patients with active RA in the first 5 cohorts of the double-blind, placebo-controlled, U.S. Phase Ib SPARTA (PRTX-100-104) trial showed that IV PRTX-100 plus methotrexate or leflunomide was well tolerated with no deaths or serious adverse events considered to be treatment-related. In the first 4 cohorts, 41 patients received once-weekly 1.5, 3, 6 and 12 ug/kg doses of IV PRTX-100 plus methotrexate or leflunomide for 5 weeks. In the fifth cohort, 20 patients received methotrexate or leflunomide plus once-weekly 240 or 420 ug IV PRTX-100 or placebo for 5 weeks followed by monthly maintenance doses at weeks 8, 12, 16 and 20. ...