Protalex Announces Data from U.S. Phase 1(b) Trial of PRTX-100 in Active Rheumatoid Arthritis Patients Presented at the 2014 EULAR Annual European Congress of Rheumatology
Novel Immune-modulatory Therapy for RA Demonstrates Potential for Disease Modification
FLORHAM PARK, N.J.-- Protalex, Inc. (OTCQB:PRTX), a clinical-stage biopharmaceutical company, today announced that results from Cohorts 1-4 of its U.S.-based multicenter Phase 1(b) randomized, multiple-dose, dose-escalation study of PRTX-100 in combination with methotrexate or leflunomide in adults with active rheumatoid arthritis (PRTX-100-104 Study) was highlighted in a poster presentation at EULAR’s Annual European Congress of Rheumatology being held in Paris, June 11-14, 2014. PRTX-100 is an investigational drug incorporating a highly purified form of Staphylococcal Protein A. The abstract is now available on EULAR’s website at www.eular.org and the complete poster is available on the Company’s website at www.protalex.com.
The poster entitled, “A Phase I Study of Staphylococcal Protein A in Patients with Active Rheumatoid Arthritis on Methotrexate,” was presented today from 11:45 a.m. to 1:30 p.m. (local time) by Dr. Edward Bernton, Protalex’s Chief Scientific Officer and Dr. Craig Wiesenhutter, Principal Investigator for the 104 Study. Their analysis included data from patients in the first four dosing cohorts of the five-cohort study through day 85 of the study protocol.
The study authors asserted, “Five weekly doses of PRTX-100 demonstrated an acceptable safety profile and although the number of patients was small, a treatment response is suggested. A delayed peak response of disease activity (4 to 8 weeks after the last dose) may indicate immune-modulatory rather than direct anti-inflammatory activity.”
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 (RA). Protalex’s lead product, PRTX-100, is a formulation of a proprietary, highly purified form of Staphylococcal Protein A, which is an immunomodulatory protein produced by bacteria. PRTX-100 has the ability, at very low concentrations, to bind to human B-lymphocytes and macrophages and to modulate immune processes. Protalex completed a Phase 1b clinical trial in adult patients with active RA in South Africa that 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. The safety, tolerability, and pharmacokinetics of PRTX-100 have now been characterized in five clinical studies.
Statements in this press release 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 June 13, 2014