Opexa Therapeutics, Inc. has announced today the Data Safety Monitoring Board (DSMB) has recommended the trial of Tovaxin to continue unmodified. Opexa Therapeutics, Inc. is the company that develops cell therapies for multiple sclerosis. This positive recommendation follows a regularly scheduled meeting of the DSMB in June and is based upon an evaluation of clinical, magnetic resonance imaging (MRI) and safety data that had been recorded for all patients to date.
The TERMS trial (Tovaxin for Early Relapsing Multiple Sclerosis) is nearing completion and the DSMB has two additional scheduled meetings in July and August of this year. Tovaxin is being evaluated in a multi-center, randomized, double blind, placebo controlled study in 150 patients suffering from Relapse Remitting Multiple Sclerosis (RRMS) or Clinically Isolated Syndrome (CIS).
It can be added that Tovaxin is an individualized T-cell therapeutic vaccine that consists of attenuated patient-specific myelin-reactive T-cells (MRTCs) against peptides of proteins from Myelin basic protein (MBP), Myelin oligodendrocyte glycoprotein (MOG) and Proteolipid protein (PLP) or combinations thereof. Recently, two-year follow up data from Phase I/II clinical studies of 22 patients showed 73% of patients on Tovaxin remained relapse free after two years with 86% experiencing no disease progression. Tovaxin is manufactured in Opexa’s in-house cGMP facility.
The Company’s(Opexa) lead product is Tovaxin, a T-cell therapy for multiple sclerosis is in Phase IIb trials. The Company holds the exclusive worldwide license for adult multipotent stem cells derived from mononuclear cells of peripheral blood. The technology allows large quantities of monocyte-derived stem cells to be produced efficiently for use in autologous therapy, thus circumventing the threat of rejection.