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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

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 tr
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SOURCE Protalex, Inc.
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