Protalex, Inc. Findings from Phase 1b Dose Escalation Study of PRTX-100 in Patients with Active Rheumatoid Arthritis
SUMMIT, N.J.--(BUSINESS WIRE)--Jul 26, 2012 - Protalex, Inc. (OTCBB: PRTX), a clinical stage biopharmaceutical company that is developing a class of drugs designed to treat a wide array of autoimmune and inflammatory diseases today announced preliminary findings from its recently completed Phase 1b randomized, multiple-dose, dose-escalation study. The study based in South Africa of PRTX-100 in adult patients with active rheumatoid arthritis (RA) demonstrated that PRTX-100 was generally safe and well tolerated in patients with active RA at all dose levels.
A total of 37 patients who had active RA on methotrexate were enrolled in 4 dose-escalating cohorts ranging from 0.15 ug/kg to 1.50 ug/kg of PRTX-100 or placebo, administered weekly for 4 weeks. Safety and disease activity were evaluated over 16 weeks following the first dose.
“The initial disease activity results from this trial demonstrated an acceptable safety profile and warrants further study of PRTX-100 at doses of 1.50 µg/kg and higher in a new clinical trial. Once the full analysis of the data from the South Africa study is shortly completed, we will be better informed of the design for the new study which we expect will provide a fuller understanding of safety and treatment effect on RA disease activity measurements as well as help define the optimal dose,” 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 April 5, 2012, which are available at the SEC's website at www.sec.gov.
PRTX-100 has the ability, at very low concentrations, to bind to and to 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. The South Africa clinical trial has demonstrated that very low doses of PRTX-100 were well tolerated in patients with active RA at all dose levels.
About Protalex, Inc.
Protalex, Inc. is a clinical stage biopharmaceutical company that is 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, has completed a Phase 1b clinical trial on adult patients with active rheumatoid arthritis in South Africa which was designed to evaluate and assess, among other things, its safety and tolerability. Protalex is planning to further study the safety and treatment effect of PRTX-100 at higher dose levels with a new clinical trial.
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.
Contact: LHA Media Relations
Adam Handelsman, 212-838-3777
Posted: July 2012