Protalex has announced the initiation of the Phase I clinical trial of its lead compound, PRTX-100. The trial is designed to assess the safety and tolerability of PRTX-100 in healthy volunteers as a step towards demonstrating efficacy in autoimmune diseases. The single-center study will assess the safety, tolerability, pharmacokinetics and immunogenicity of PRTX-100 in healthy volunteers.
PRTX-100 is a natural product that acts as a selective immune modulator, restoring normal immune function by preventing the activation of lymphoid cells, the communication between cells of the immune system necessary for abnormal immune responses and the secretion of pathogenic cytokines. PRTX-100 has demonstrated efficacy in well-accepted models of rheumatoid arthritis.