NEW HOPE, Pa.--(BUSINESS WIRE)--Protalex, Inc. (OTCBB: PRTX) announced today that it continues to make significant progress in its clinical development of PRTX-100 in multiple indications. In rheumatoid arthritis (RA), building on the results of the successful Phase Ia safety study, the company initiated a Phase Ib study in healthy volunteers on June 20, 2007. This study follows the May 4, 2007 filing of an amendment to the company’s open Investigational New Drug application with the United States Food and Drug Administration. The amendment included the final Phase Ia safety study report, CMC update, and a protocol for the Phase Ib study. This additional study is designed to gain more detailed information on biomarkers, including gene expression profiling and platelet functional assessments which will allow for more optimized patient selection and targeting in the upcoming Phase II study. The trial will also extend the clinical investigation of PRTX-100 tolerability, pharmacokinetics (PK), and pharmacodynamics at higher dose ranges. The Phase II randomized, placebo controlled, multi-center study in patients with active rheumatoid arthritis, is scheduled to commence enrollment in early 2008.
