Protalex enrolls first patient in Phase 1/2 trial of PRTX-100 for ITP
Protalex announced that the company has enrolled the first of three patients in cohort four of its U.S./U.K. Phase 1/2 trial evaluating PRTX-100 for the treatment of adults with persistent/chronic Immune Thrombocytopenia, or ITP. The fourth cohort was initiated after a planned, interim analysis of safety and efficacy data from cohort three. Patient one, based in the U.S., received 12.0 micrograms/kg, double the dose used in the prior cohort of 6.0 micrograms/kg. PRTX-100 has been granted orphan drug designation in the U.S. and in Europe for the treatment of ITP. The number of clinical trial sites in the 202 Study has been expanded to the U.K to support enrollment and broaden access to the potential patient pool. The 202 Study is an open-label, dose-escalation study that can enroll patients in up to six cohorts. Under the study protocol, patients receive four weekly intravenous doses of PRTX-100 and are monitored for up to 48 weeks thereafter. The primary endpoint of the 202 Study is a platelet response to PRTX-100. Secondary endpoints include safety, immunogenicity, and pharmacokinetics. Enrollment is currently underway at several clinical sites in the U.S. and in the U.K.