Protalex Announces PRTX-100 Trial Results For Rheumatoid Arthritis

Protalex, Inc. announced in a press release that its study of PRTX-100 has produced preliminary findings. Protalex, Inc. is a biopharmaceutical company that focuses on autoimmune and inflammatory diseases. The study, based in the U.S., is a clinical trial of the drug in combination with leflunomide or methotrexate. The Phase I (b) multi-center trial of the investigational drug is for adults with rheumatoid arthritis (RA).  Edward Bernton, M.D., Protalex’s Chief Scientific Officer said, "We are pleased that these preliminary findings extend our knowledge of the safety and pharmacologic profile of PRTX-100 at higher doses than used in prior studies, and have included them in a recent submission to the U.S. Food and Drug Administration. Moreover, we are encouraged by the promising effects on certain key measures of disease activity, and we are excited by the potential of PRTX-100 as a novel immunomodulatory therapy for RA and possibly other autoimmune diseases."

Rheumatoid Arthritis

RA is an abnormal immune response, an autoimmune disease. The body makes mistakes and attacks healthy tissues and joints, causing inflammation that is harmful in the short and long term.  In the U.S., a million and a half people have RA. It is more prevalent in women than men, and women contract it at an earlier age. Individuals experience the disorder differently, with varying degrees of pain and loss of mobility. Symptoms may flare up or subside on a daily basis or cause trouble for months with no relief. Current medications do not cure RA, but rather treat the symptoms and provide some pain relief.

PRTX-100

PRTX-100 is a purified Staphylococcal Protein. The investigational drug formulation is proprietary. At low concentrations, it binds to B-lymphocytes and macrophages, thereby modulating immune system response along signaling pathways. Very low doses of the drug have shown in animal studies to be vigorous mediators of the inflammatory response. In humans, the agent has proved safe.    

PRTX-100 Clinical Study

Protalex states that the data presented is from four of the five dosing groups up to day 85 of the study. Forty-one patients enrolled through five centers. The findings suggest that patients tolerated the dose well and PRTX-100 seemed safe. Side effects or adverse events were indistinguishable from those who had received a placebo. The company plans to publish the results in the spring.

Source:

http://www.protalex.com/Press/20140210_PRTX-Interim%20Findings%202-10-14.pdf