The good news is that this vaccine is to help people who already have MS, so if all goes according to plan, this might be an eventual alternative to the current disease-modifying drugs. Read on for the simplified, yet still fairly complex, details…
What Is It?
NeuroVax is a “therapeutic” vaccine. Unlike regular vaccines or immunizations, which are given to prevent disease, therapeutic vaccines are given to people who already have a disease in order to treat the disease.How Does It Work?
Vaccines usually work by stimulating specific parts of the immune system to “teach” it to fight off specific invaders that attack the body, such as viruses or bacteria. MS is an autoimmune disease, meaning that the body is being attacked by its own immune system.Therefore, this vaccine has been developed to teach one part of the immune system (specifically, FOXP3+ regulatory T-cells) to control or down regulate the part of the immune system that attacks myelin in people with MS (pathogenic T-cells).
- Pathogenic T-cells are a subset of white blood cells, which in the case of MS, attack myelin in the brain, spinal cord and optic nerves, causing inflammation and eventual demyelination.
- FOXP3+ regulatory T-cells (or Treg cells) control pathogenic T-cells in healthy individuals, giving them the signal of when to stop attacking foreign invaders. People with MS have been shown to have lower levels of these FOXP3+ regulatory T-cells than healthy individuals. NeuroVax is designed to restore the level of FOXP3+ regulatory T-cells to the same level as in healthy individuals.
How Is NeuroVax Administered?
NeuroVax is injected intramuscularly every four weeks indefinitely.What Is Happening Now?
The first trial patient for a large Phase II trial was injected at a study site in Bulgaria in early March 2007. As described on the website of Orchestra Therapeutics: "This trial is a multi-center, randomized, double-blind, placebo-controlled 48-week study to assess the safety and efficacy of NeuroVax. Two hundred subjects with relapsing-remitting MS, with an Expanded Disability Status Scale (EDSS) score of ≤ 5.5 and meeting all inclusion/exclusion criteria, will be enrolled in the study in several Central and Eastern European countries.”Other Interesting Facts
- Orchestra Therapeutics was known as the Immune Response Corporation until a “rebranding” in early April 2007, when they changed their name and terminated clinical trials on their HIV product, Remune. Remune was also a therapeutic vaccine that showed promise in animal models but did not show therapeutic benefit in humans. Orchestra Therapeutics is now turning all efforts to autoimmune diseases and is beginning development on therapeutic vaccines for psoriasis and rheumatoid arthritis.
- Currently, no true therapeutic vaccines exist.
- Preventative vaccines usually prevent disease for several years after one to three doses by tricking the body to believe that it has been infected with a bacteria or virus, so that it creates specific cells to fight it off and becomes “immune” to that disease. These cells are activated when exposed to the invader. NeuroVax is different in that it is stimulating production of FOXP3+ regulatory T-cells and trying to keep them at a consistent level over time, so that regular dosing is needed.
