About Protalex, Inc.
Protalex, Inc. is a clinical stage biopharmaceutical company that is developing a class of biopharmaceutical drugs for treating a wide array of autoimmune and inflammatory diseases, including rheumatoid arthritis. Protalex’s lead product PRTX-100, which is formulated with a highly-purified form of staphylococcal protein A, has completed a Phase 1b clinical trial on adult patients with active rheumatoid arthritis (RA) in South Africa which was designed to evaluate and assess, among other things, its safety and tolerability. Protalex is planning to further study the safety and treatment effect of PRTX-100 at higher dose levels with a new clinical trial.
PRTX-100 100 is a highly-purified form of the Staphylococcal bacterial protein known as Protein A. PRTX-100 has the ability, at very low concentrations, to bind to and to regulate activation of human B-lymphocytes and macrophages which are the key cells mediating inflammation in certain autoimmune diseases. Laboratory studies indicate that the mechanism involves interaction with specific intracellular signaling pathways. Pre-clinical studies also demonstrate that very low doses of PRTX-100 have potent therapeutic effects in certain models of immune-mediated inflammatory diseases. The South Africa trial has demonstrated that very low doses of PRTX-100 were well tolerated in patients with active RA at all dose levels.
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