SUMMIT, N.J., Jan. 17, 2012 (GLOBE NEWSWIRE) -- Protalex, Inc. (OTCBB:PRTX), a clinical stage biopharmaceutical company which is engaged in developing a class of drugs for treating autoimmune and inflammatory diseases today announced it has completed patient dosing in the 4th cohort of Part A of its ongoing multicenter Phase 1b dose escalation clinical study of PRTX-100 in adult patients with active rheumatoid arthritis (RA) being conducted in South Africa. A total of 37 patients were randomized in 4 dose escalating cohorts.
The primary objective of this Phase 1b randomized, multiple-dose, dose-escalation study of PRTX-100 is to assess the safety and tolerability of intravenous PRTX-100 administered weekly in patients with active RA on methotrexate therapy. The secondary objectives include determining the effects of PRTX-100 on measures of disease activity, assessing the immunogenicity of PRTX-100, evaluating the pharmacokinetic (PK) parameters after repeated doses, and determining if a relationship exists between the immunogenicity of PRTX-100 and safety, PK and efficacy parameters.
"We believe there is now sufficient safety and efficacy data to review in order to determine dose selection for Part B, the second phase of the study, which is designed to provide a better estimate of treatment effect on RA disease activity measures. If results from the review are favorable, Part B, if approved, would allow for the expansion of a selected dose based on pre-defined criteria and in accordance with our clinical plan," stated William E. Gannon, Jr., M.D., Chief Medical Officer of Protalex.
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 Quarterly Report on Form 10-Q filed on January 17, 2012, which are available at the SEC's website at www.sec.gov.
About PRTX-100
PRTX-100 is a highly-purified form of the Staphylococcal bacterial protein known as Protein A. PRTX-100 has the ability, at very low concentrations, to bind to and to down-regulate activation of human B-lymphocytes and macrophages which are the key cells mediating 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.
About Protalex, Inc.
Protalex, Inc. is a clinical stage biopharmaceutical company engaged in developing a class of biopharmaceutical drugs for treating autoimmune and inflammatory diseases, including but not limited to, rheumatoid arthritis. Protalex's lead product PRTX-100, which is formulated with a highly-purified form of staphylococcal protein A, is currently undergoing a Phase 1b clinical trial on adult patients with active rheumatoid arthritis in South Africa to evaluate and assess, among other things, its safety and tolerability.
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.