Protalex initiates dosing in multicenter PRTX-100 Phase 1b clinical study in RA

Aug 20 2010

Protalex, Inc. (OTCBB:PRTX), a clinical stage biopharmaceutical company engaged in developing a class of biopharmaceutical drugs for treating autoimmune and inflammatory diseases, today announced the dosing of the first patient in a multicenter Phase 1b clinical study of PRTX-100 in adult patients with active Rheumatoid Arthritis (RA). The study is being conducted in South Africa.

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 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. 

"Protalex is very pleased to be conducting this trial in South Africa in collaboration with a leading global biopharmaceutical services organization. Given the large number of patients with RA in South Africa and the quality of the clinical Phase I sites located there, Protalex is confident that this first in-patient population development program is off to a good start," stated William E. Gannon, Jr., M.D., Chief Medical Officer of Protalex.