12:00 AM
Oct 08, 2012
 |  BioCentury  |  Product Development

Opexa's progression in MS

Efficacy, MOA behind Opexa's shift to secondary progressive MS for Tcelna

Two years after Tcelna failed a Phase II trial in relapsing-remitting multiple sclerosis, Opexa Therapeutics Inc. has restarted development of the cell therapy with a new focus on secondary progressive MS. The company is going after later stage, active disease because the cell therapy's mode of action suggests it is more effective in that setting.

The autologous cell therapy contains myelin reactive T cells (MRTCs) primed and expanded ex vivowith myelin basic protein (MBP), proteolipid protein 1 (PLP1) and myelin oligodendrocyte glycoprotein (MOG). These proteins are expressed on the surface of MRTCs - the cells that destroy the myelin sheath in MS patients.

The attenuated myelin-peptide reactive T cells are extracted from the patient, expanded by Opexa, irradiated to neutralize the cells and reinjected into the patient. Upon delivery, the cells trigger an immune response against the endogenous MRTCs that play a role in the destruction of myelin sheath.

Tcelna is localized in the membranes that surround the CNS and primes the immune system to destroy MRTCs in the brain.

In September, Opexa started a Phase IIb trial of Tcelna (formerly Tovaxin) to treat secondary progressive multiple sclerosis (SPMS). The company plans to enroll 180 patients, with a primary endpoint of brain atrophy as measured by percent of brain volume change at two years.

About 90% of relapsing-remitting MS patients progress to...

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