Preliminary findings from Protalex's PRTX-100 Phase 1b study on active rheumatoid arthritis

Jul 26 2012

Protalex, Inc. (OTCBB: PRTX), a clinical stage biopharmaceutical company that is developing a class of drugs designed to treat a wide array of autoimmune and inflammatory diseases today announced preliminary findings from its recently completed Phase 1b randomized, multiple-dose, dose-escalation study. The study based in South Africa of PRTX-100 in adult patients with active rheumatoid arthritis (RA) demonstrated that PRTX-100 was generally safe and well tolerated in patients with active RA at all dose levels.

A total of 37 patients who had active RA on methotrexate were enrolled in 4 dose-escalating cohorts ranging from 0.15 ug/kg to 1.50 ug/kg of PRTX-100 or placebo, administered weekly for 4 weeks. Safety and disease activity were evaluated over 16 weeks following the first dose.

"The initial disease activity results from this trial demonstrated an acceptable safety profile and warrants further study of PRTX-100 at doses of 1.50 µg/kg and higher in a new clinical trial. Once the full analysis of the data from the South Africa study is shortly completed, we will be better informed of the design for the new study which we expect will provide a fuller understanding of safety and treatment effect on RA disease activity measurements as well as help define the optimal dose," stated William E. Gannon, Jr., M.D., Chief Medical Officer of Protalex.

Source: Protalex, Inc.