Tovaxin keeps multiple scelorosis patients relapse-free, says Opexa

Tovaxin, a multiple sclerosis drug developed by Opexa Therapeutics Inc, keeps  more than 83 percent of patients relapse-free after a year.

Tovaxin data from a phase 2 B clinical study showed that 85% of patients treated with the drug responded favorably, while 16 % showed actual and sustained improvement in disability, according to a press release.

Tovaxin is a personalized T-cell immunotherapy for multiple sclerosis (MS).

The clinical study using Tovaxin evalutaed 150 patients with Relapsing Remitting MS (RRMS) in adouble-blind, placebo-controlled, 52-week programme.

Analysis of the Tovaxin data found that more than 83% of the Tovaxin-treated group remained relapse free at one year and the annualized relapse rate after treatment decreased to 0.20, a 42% reduction compared to placebo.

Also, 73% of the Tovaxin-treated patients showed stabilization or improvement in MS disability, including 16.5% with a sustained improvement in the Expanded Disability Status Scale (EDSS) of at least one full point.

Tovaxin-treated group also demonstrated a reduction in brain atrophy and fewer inflammatory brain lesions that progressed to “black holes,” as compared to the placebo-treated group, MRI scans revealed.

Tovaxin treatment was well tolerated, with no serious adverse events reported in any Tovaxin-treated patient.

Clinical benefits include not only reduction in relapses, but a surprising reversal of disability in over 16% of Tovaxin-treated patients. Along with MRI data suggesting a reduction in neuronal cell loss, these results raise the possibility that Tovaxin-treatment may have neuroprotective as well as disease-modifying effects, the release stated quoting a neurologist.

This post-hoc analysis which represents 86% of the total patient population in the TERMS study was conducted to evaluate Tovaxin treatment among study patients with the same baseline disease activity that is being targeted for inclusion in the forthcoming Phase IIb study.

Opexa  plans to recruit similar patients for another Phase IIb study of Tovaxin, which is a vaccine tailored to individual patients. It helps limit attacks by immune system cells called T-cells on myelin, the protein sheath that protects nerves.

Tovaxin is derived from T-cells isolated from peripheral blood, expanded ex vivo. These cells are then reintroduced into the patients via subcutaneous injections. This process triggers a potent immune response against specific subsets of autoreactive T-cells known to attack myelin. Autoreactive T-cells are believed to be a primary cause of MS attacks and nervous system damage.

Analysis of immunological data from the TERMS trial indicate that Tovaxin can successfully induce changes in T-cell reactivity to all three targeted myelin antigens implicated in the autoimmune attacks causing neurologic damage in MS. Tovaxin is not broadly immunosuppressive, an important feature of its favorable safety profile.

What is multiple sclerosis?
Multiple sclerosis is a nervous system disease that affects brain and spinal cord. It damages the myelin sheath, the material that surrounds and protects your nerve cells. This damage slows down or blocks messages between the brain and the body. Major symptoms of MS can include: visual disturbances, muscle weakness; trouble with coordination and balance; sensations such as numbness, prickling, or “pins and needles; thinking and memory problems.Multiple sclerosis affects woman more than men.

Multiple Sclerosis  often begins between the ages of 20 and 40. Usually, the disease is mild, but some people lose the ability to write, speak or walk. There is no cure for MS, but medicines may slow it down and help control symptoms. Physical and occupational therapy may also help.

Based in The Woodlands, Texas,Opexa Therapeutics, Inc focuses on patient-specific cellular therapies for the treatment of autoimmune diseases.

The news more than tripled the value of Opexa in bourses.