Protalex, Inc. Announces Enrollment of First Patients in 3rd Cohort of Its Ongoing Phase 1b Dose Escalation Study of PRTX-100 in Patients With Active Rheumatoid Arthritis
SUMMIT, N.J., March 3, 2011 (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 enrollment of the first patients in the 3rd cohort 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. The dose was increased by a factor of two from the 2nd cohort.
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 rheumatoid arthritis 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.
The first sequential dose escalation phase of this Phase 1b study will enroll up to 40 patients in four cohorts and is expected to be completed in the second calendar quarter of 2011. If results are favorable, the second phase of the study, if approved, would allow for the expansion of selected dose groups based on pre-defined criteria. "Following a planned interim safety review with our Data Safety Monitoring Committee and discussions with our Scientific Advisory Board, we are pleased to continue the enrollment and dosing of patients and to progress in accordance with our clinical plan, utilizing our enhanced cash position resulting from the recent $2 million draw down from our credit facility," stated William E. Gannon, Jr., M.D., Chief Medical Officer of Protalex.
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.
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: Kirk M. Warshaw, CFO (215) 862-9720Source: Protalex, Inc.
Released March 3, 2011