About Protalex, Inc.
Protalex, Inc. is a clinical-stage biopharmaceutical company focused on the development of a class of drugs for treating a wide array of autoimmune and inflammatory diseases, including rheumatoid arthritis. Protalex’s lead product, PRTX-100, is derived from bacteria that are known to circumvent aspects of the human immune system.
PRTX-100 is a formulation of a proprietary, highly purified form of the Staphylococcal Protein A, which is an immunomodulatory protein produced by Staphylococcus aureus bacteria. PRTX-100 has the ability, at very low concentrations, to bind to human B-lymphocytes and macrophages and to modulate immune processes that mediate inflammation in certain autoimmune diseases. Laboratory studies indicate that the mechanism involves interaction with specific immunologic signaling pathways. Pre-clinical animal studies also demonstrate that very low doses of PRTX-100 have potent therapeutic effects in certain models of immune mediated inflammatory diseases. To date, human clinical studies indicate that PRTX-100 is generally safe and well tolerated at all dose levels evaluated.
PRTX-100 Clinical Experience
The company has completed five clinical studies in man. In January 2012 Protalex completed a Phase 1b clinical trial in adult patients with active rheumatoid arthritis (RA) in South Africa (Study PRTX-100-103) which demonstrated that PRTX-100 was generally safe and well tolerated at all dose levels, and at the higher doses, more patients showed improvement in their CDAI (Clinical Disease Activity Index) for RA than did patients at the lower dose or placebo cohorts. In November 2012, Protalex commenced a new Phase 1b double blind, placebo controlled, multicenter, multiple-dose, dose escalation study (Study PRTX-100-104) in patients with active RA at nine U.S. sites to investigate safety and possible treatment effects at higher doses. Protalex completed dosing of the final cohort in this U.S. Study in July 2014 and expects to announce top line data from the fifth and final cohort in the fourth quarter of 2014.
Statements at this web site, including with respect to the outcome of future studies, that are not statements of historical or current fact constitute "forward-looking statements." Such forward-looking statements involve known and unknown risks, uncertainties and other unknown factors that could cause the Company's actual operating results to be materially different from any historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements that explicitly describe these risks and uncertainties, readers are urged to consider statements that contain terms such as "believes," "belief," "expects," "expect," "intends," "intend," "anticipate," "anticipates," "plans," "plan," to be uncertain and forward-looking. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company's filings with Securities and Exchange Commission.