11 April 2018 - - Florham Park, New Jersey-based clinical-stage biopharmaceutical company Protalex, Inc. (OTCQB: PRTX) has enrolled the first of three patients in cohort four of its US/UK Phase 1/2 trial evaluating PRTX-100, , a new generation immunomodulatory therapy, for the treatment of adults with persistent/chronic immune thrombocytopenia (ITP), the company said.
The fourth cohort was initiated after a planned, interim analysis of safety and efficacy data from cohort three. Patient one, based in the US, received 12.0 micrograms/kg, double the dose used in the prior cohort of 6.0 micrograms/kg.
PRTX-100 has been granted orphan drug designation in the US and in Europe for the treatment of ITP. The number of clinical trial sites in the 202 Study, an open-label, dose-escalation study that can enroll patients in up to six cohorts, has been expanded to the UK to support enrollment and broaden access to the potential patient pool.
The primary endpoint of the 202 Study is a platelet response to PRTX-100. Secondary endpoints include safety, immunogenicity, and pharmacokinetics.
PRTX-100 is a highly purified form of SpA, an immunomodulatory protein known to modify aspects of the human immune system. PRTX-100 has the ability, at very low concentrations, to bind to human B-lymphocytes and macrophages and to modulate immune processes.
Pre-clinical data indicate that PRTX-100 may have the potential to treat ITP by reducing the immune-mediated destruction of the platelets. PRTX-100 is given as a short intravenous infusion.
Protalex is focused on the development of a class of drugs for treating autoimmune and inflammatory diseases including rheumatoid arthritis (RA) and ITP. In the US, Protalex has open INDs for the treatment of RA and ITP and in Europe, an open IMPD for ITP.