Protalex Inc. announced that following a planned interim data review by its independent Safety Monitoring Committee (SMC), the Company is continuing enrollment and increasing the dose for subjects in its U.S. Phase 1/2 study of PRTX-100 in adults with persistent/chronic Immune Thrombocytopenia (ITP) (PRTX-100-202 Study). The dose of PRTX-100 for subjects in the next treatment group (3.0 micrograms/kg) will be three times that of the initial starting dosage (1.0 micrograms/kg). PRTX-100, Protalex's lead drug candidate, is a highly purified form of Staphylococcal protein A (SpA), which was recently granted Orphan Drug Designation in the U.S. and in Europe for the treatment of ITP.

PRTX-100 is also the subject of ongoing clinical development in Rheumatoid Arthritis (RA). The 202 Study is an open-label, dose escalating study that can enroll up to 36 patients in as many as six cohorts. Each patient will receive four weekly intravenous doses of PRTX-100 and will be monitored for up to 48 weeks thereafter.

The primary study endpoint of the 202 Study is a platelet response to PRTX-100. Secondary endpoints include safety, immunogenicity, and pharmacokinetics. Enrollment in the 202 Study is currently taking place at several study sites in the U.S.