The Staphylococcal Protein A based PRTX-100 drug administered to patients with Active Rheumatoid Arthritis
SUMMIT, N.J., Oct. 18, 2012 /PRNewswire/ -- Protalex, Inc. (OTCBB: PRTX), a clinical stage biopharmaceutical company, today announced that its abstract on results from the recently completed PRTX-100 Phase 1b randomized, multiple-dose, dose-escalation study in South Africa of PRTX-100 has been accepted for oral presentation at the American College of Rheumatology (ACR) 2012 Annual Meeting to be held in Washington D.C. November 9-14. Protalex is focused on the development of a class of drugs designed to treat autoimmune and inflammatory diseases including rheumatoid arthritis (RA),
The abstract entitled "A Phase 1, Randomized, Double-Blind, Placebo-Controlled Multiple-Dose Study of Intravenous Staphylococcal Protein A in Patients with Active Rheumatoid Arthritis On Methotrexate: Safety, Pharmacokinetics and Efficacy" will be presented by Protalex's Chief Scientist and lead author Dr. Edward Bernton on Sunday, November 11th at 5:00 pm in Ballroom A of the Washington Convention Center.
The study of PRTX-100, a proprietary form of purified Staphylococcal protein A, was conducted in South Africa on 37 adult patients with active RA and demonstrated that the drug was generally safe and well-tolerated at all dose levels. More patients in the higher dose cohorts showed improvement in their CDAI (Clinical Disease Activity Index for RA) than did patients at the lower dose or placebo cohorts.
A more complete description of Protalex, its business and this study can be found in the reports it periodically files with the Securities and Exchange Commission (SEC) pursuant to the Securities Exchange Act of 1934, as amended, including its Annual Report on Form 10-K filed on August 29, 2012, and its Quarterly Report on Form 10-Q filed on October 12, 2012 which are available at the SEC's website at www.sec.gov
About Protalex, Inc.
Protalex, Inc. is a clinical stage biopharmaceutical company focused on the development of a class of biopharmaceutical drugs for treating autoimmune and inflammatory diseases, including but not limited to, rheumatoid arthritis. Protalex's lead product, PRTX-100, is formulated with a 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. The study was designed to evaluate and assess, among other things, its safety and tolerability. 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. Pre-clinical studies also demonstrate that very low doses of PRTX-100 have potent therapeutic effects in certain models of immune-mediated inflammatory diseases.
Protalex is planning to further study the safety and treatment effect of PRTX-100 at higher dose levels with a new clinical trial expected to commence in the U.S. by December 2012.
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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SOURCE Protalex, Inc.