Orphan Drug Status Granted to Immune Thrombocytopenia Therapy
Protalex announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to PRTX-100 for the treatment of immune thrombocytopenia (ITP).
Pre-clinical data indicates that PRTX-100 may have the potential to treat ITP by reducing the immune-mediated destruction of platelets. Furthermore, PRTX-100 has established an acceptable safety profile based on data from patients treated in five clinical studies including patients with rheumatoid arthritis (RA). In two Phase 1b clinical trials in adult patients with active RA, PRTX-100 was generally safe and well tolerated at all dose levels. At certain higher doses, more patients showed improvement in measures of RA disease activity than did patients at the lower dose or placebo cohorts.
PRTX-100 is a highly purified form of Staphylococcal Protein A with the ability, at very low concentrations, to bind to human B-lymphocytes and macrophages and to modulate immune processes.
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