SUMMIT, N.J., Nov. 8, 2012 /PRNewswire/ -- Protalex, Inc. (OTCBB: PRTX), a clinical stage biopharmaceutical company, today announced that it has begun screening patients at sites in the U.S. for its new multicenter Phase 1b randomized, multiple-dose, dose-escalation study of PRTX-100 in adults with active rheumatoid arthritis (RA). Protalex is focused on the development of a class of drugs designed to treat autoimmune and inflammatory diseases including RA.
The primary objective of this Phase 1b study of PRTX-100 will be to further assess the safety and tolerability of intravenous PRTX-100 administered weekly over 5 weeks in patients with active rheumatoid arthritis on methotrexate therapy. The secondary objectives include determining the effects of PRTX-100 on measures of disease activity, assessing the immunogenicity and evaluating the pharmacokinetic (PK) parameters after repeated doses, and determining possible relationships between the immunogenicity of PRTX-100 and safety, PK and efficacy parameters.
The sequential dose escalation phase of this Phase1b study will randomize up to 40 patients into the dose escalation cohorts starting at 1.50 ug/kg PRTX-100 or placebo, followed by up to 12 additional randomized patients for cohort expansion. Enrollment is expected to take place at study sites in both the U.S. and South Africa.
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 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.
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.
SOURCE Protalex, Inc.