Protalex Receives Third Interim Review from Independent Data Safety Monitoring Committee in its Phase 1b Trial of PRTX-100 in Rheumatoid Arthritis
SUMMIT, N.J.-- Protalex, Inc. (OTCBB: PRTX), a clinical-stage biopharmaceutical company, today announced that following a planned interim safety review by its Independent Data Safety Monitoring Committee (SMC), the Company is continuing enrollment in its multicenter Phase 1b randomized, multiple-dose, dose-escalation study of PRTX-100 in combination with methotrexate or leflunomide in adults with active rheumatoid arthritis (RA). PRTX-100 is a candidate drug incorporating a highly-purified form of Staphylococcal Protein A.
The SMC’s third cumulative study safety data review, which included data from the current 12.0 mcg/kg dosing cohort, noted no dose-limiting toxicities or safety signals which would prevent continuing the study in accordance with the current protocol. The Company has elected to expand the 3.0 mcg, 6.0 mcg, and 12.0 mcg/kg dose cohorts from 8 patients to 12 patients per group. These three cohorts will then include nine active- and three placebo-treated patients per dose group. Accordingly, the sequential dose-escalation phase, which includes these three expanded cohorts, is now expected to enroll up to 44 patients, with doses ranging from 1.5 mcg/kg up to 12.0 mcg/kg.
Additionally, the SMC had no safety concerns regarding with the Company’s current intent to amend its Phase 1b protocol with respect to the fifth and final dosing cohort. The amended cohort 5 sub-study, if approved, will include additional monthly maintenance doses of PRTX-100. The dose for infusions will be in the 3.0 mcg/kg to 6.0 mcg/kg range. Patients may receive more doses of PRTX-100, but the cumulative dose will not exceed that of the current 12 ug/kg cohort. This cohort 5 sub-study will enroll up to 12 additional patients.
The primary objective of this Phase 1b study is to assess the safety and tolerability of four different doses of intravenous PRTX-100 administered weekly over five weeks in patients with active RA on methotrexate or leflunomide therapy. The primary objective of the additional sub-study is to assess safety and tolerability of one of these doses administered on a modified schedule. 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.
Enrollment is currently taking place at five study sites in the U.S. which may be expanded by an additional two to four U.S. sites.
About Protalex, Inc.
Protalex, Inc. is a clinical-stage biopharmaceutical company focused on the development of a class of drugs for treating autoimmune and inflammatory diseases, including 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 in adult patients with active rheumatoid arthritis in South Africa. This trial demonstrated that PRTX-100 was generally safe and well tolerated at all dose levels, 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.
Anne Marie Fields, 212-838-3777
Source: Protalex, Inc.
Released July 23, 2013