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Protalex's PRTX-100 in rheumatoid arthritis receives positive Phase 1B review

Protalex announced that following a planned interim safety review by its independent Data Safety Monitoring Committee, the company is continuing enrollment and increasing the dose for subjects in its multicenter Phase 1b randomized, multiple-dose, dose-escalation study of PRTX-100 in combination with methotrexate or leflunomide in adults with active rheumatoid arthritis. The dose of PRTX-100 for subjects in the current treatment group (12.0 micrograms/kg) is eight times that of the initial starting dosage. The primary objective of this Phase 1b study is to assess the safety and tolerability of intravenous PRTX-100 administered weekly over five weeks in subjects with active RA on methotrexate or leflunomide therapy.