Protalex initiates enrollment in 3rd cohort of PRTX-100 Phase 1b dose escalation clinical study in RA

Mar 3 2011

Protalex, Inc (OTCBB:PRTX), a clinical stage biopharmaceutical company which is engaged in developing a class of drugs for treating autoimmune and inflammatory diseases, today announced enrollment of the first patients in the 3^rd cohort of its ongoing multicenter Phase 1b dose escalation clinical study of PRTX-100 in adult patients with active Rheumatoid Arthritis (RA) being conducted in South Africa. The dose was increased by a factor of two from the 2^nd cohort.

The primary objective of this Phase 1b randomized, multiple-dose, dose-escalation study of PRTX-100 is to assess the safety and tolerability of intravenous PRTX-100 administered weekly in patients with active rheumatoid arthritis on methotrexate therapy. The secondary objectives include determining the effects of PRTX-100 on measures of disease activity, assessing the immunogenicity of PRTX-100, evaluating the pharmacokinetic (PK) parameters after repeated doses, and determining if a relationship exists between the immunogenicity of PRTX-100 and safety, PK and efficacy parameters.

The first sequential dose escalation phase of this Phase 1b study will enroll up to 40 patients in four cohorts and is expected to be completed in the second calendar quarter of 2011. If results are favorable, the second phase of the study, if approved, would allow for the expansion of selected dose groups based on pre-defined criteria.  

"Following a planned interim safety review with our Data Safety Monitoring Committee and discussions with our Scientific Advisory Board, we are pleased to continue the enrollment and dosing of patients and to progress in accordance with our clinical plan, utilizing our enhanced cash position resulting from the recent $2 million draw down from our credit facility," stated William E. Gannon, Jr., M.D., Chief Medical Officer of Protalex.