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Protalex, Inc. Announces Screening Of First Patients In U.S. For New Trial Of PRTX-100 In Patients With Active Rheumatoid Arthritis
Date:11/8/2012

eating autoimmune and inflammatory diseases, including but not limited to, rheumatoid arthritis. Protalex's lead product, PRTX-100, is formulated with a proprietary highly purified form of Staphylococcal Protein A, and has completed a Phase 1b clinical trial on adult patients with active rheumatoid arthritis in South Africa which demonstrated that PRTX-100 was generally safe and well tolerated at all dose level 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. PRTX-100 has the ability, at very low concentrations, to bind to and to regulate activation of human B-lymphocytes and macrophages, which mediate inflammation in certain autoimmune diseases.  Laboratory studies indicate that the mechanism involves interaction with specific intracellular signaling pathways.

Forward-Looking Statements

Statements in this press release, including with respect to the outcome of the Phase 1b study described, 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.

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