"Protalex, Inc., a clinical-stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) has awarded the Company a $403,000 grant to support future clinical development activity of PRTX-100 as a treatment for Immune Thrombocytopenia (ITP). The goal of FDA's OOPD Orphan Products Clinical Trials Grants Program is to encourage the clinical development of new drugs for use in rare diseases or conditions where no current therapy exists, or where the candidate drug will be superior to the existing therapy.
PRTX-100 is a highly purified form of Staphylococcal protein A (SpA), which is an immunomodulatory protein known to modify aspects of the human immune system. PRTX-100 is a new generation immunomodulatory therapy and has been granted Orphan Drug Designation as a potential treatment for ITP in both the U.S. and Europe.
Protalex is currently enrolling patients into two Phase 1/2 dose-escalating studies of PRTX-100 as a potential new treatment for ITP at several sites in the U.S. (the 202 Study) and in Europe (the 203 Study) and has so far seen patients in each completed lower dose cohort achieve a protocol-defined platelet response.""
- From Protalex Press Release