A First Line, Personalized, Treatment for MS completes phase II studies

information provided to us by Thomas Mann

Tovaxin®

Opexa's lead product candidate is Tovaxin, a personalized T-cell vaccine for the treatment of multiple sclerosis (MS) that is specifically tailored to each patient's disease profile. Opexa believes the potential combination of efficacy, superior safety, improved tolerability and patient-friendly administration schedule may position Tovaxin as the MS treatment of choice as compared to existing therapeutic options.

Tovaxin is designed to reduce the number of specific subsets of autoreactive T-cells known to attack myelin. Tovaxin is manufactured using Opexa Therapeutics’ proprietary method for the production of patient-specific T-cell vaccines, which comprises the collection of blood from the MS patient, the harvest and expansion of disease-causing T-cells from the blood, and the return of these expanded, irradiated T-cells back to the patient. These attenuated T-cells, which comprise the Tovaxin vaccine, are reintroduced into the patient via subcutaneous injection to trigger a therapeutic immune system response.

Tovaxin is being developed as a first line treatment for MS. The treatment will consist of donating blood and creating a vaccine using the patient’s own cells. The vaccine cells will be irradiated to render them unable to divide, but able to evoke an immune response. The vaccines will be administered in the doctor’s office as a subcutaneous injection in the arm given five times a year. The first four injections are administered a month apart with the fifth and final injection being administered two months after the fourth. While many other MS treatments have constant side effects such as flu symptoms, injection site problems, and serious adverse events, Tovaxin has not had any treatment related serious adverse events (SAEs). The most common side effect reported form clinical studies has been mild to moderate injection site reaction that usually resolves without treatment within 24 hours. Tovaxin therapy is specific for the immune response against myelin destroying T cells and does not cause a general immunosuppression. Tovaxin may be a strong alternative for subjects who do not want to start hospital infusions or weekly injections, or have not been able to tolerate the side effects or infections of immunosuppressant drugs on the market. 

Tovaxin could represent a viable alternative for patients who:

• Have chosen to stop or not start treatments;
• Are newly diagnosed with MS;
• Are dissatisfied with currently marketed drugs.

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