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Posted by Elaine Moore Dec 1, 2007 |
The UK biopharmaceutical firm Apitope has developed a vaccine that could halt disease progression in multiple sclerosis (MS). The drug ATX-MS-1467 has been tested in six patients with secondary progressive multiple sclerosis (SPMS) in a Phase I/IIa trial with encouraging results. The trial demonstrated safety, and in one patient, a good clinical improvement in symptoms, particularly in eyesight, was seen. The name Apitope is derived from the class of drug called antigen processing independent epiTOPES or Apitopes.
MS is characterized by destruction of the myelin sheath that covers and protects nerves. Current therapies for MS are focused on reducing inflammation around nerve cells to reduce damage to the myelin sheath. Apitope uses a different approach in that it aims to retune immune system cells so that they no longer over-react to myelin basic protein, the primary constituent of the myelin sheath. Ultimately, the T lymphocyte cells that target myelin basic protein would be replaced by regulatory T lymphocytes that show tolerance to myelin protein. This is accomplished by directing the cells to produce the cytokine interleukin-10 (IL-10), which is an anti-inflammatory cytokine.
Initial studies show that the vaccine is effective. The concept behind it is bystander suppression in which the immune system no longer over-reacts to myelin basic proteins or other proteins such myelin oligodendrocyte glycoprotein and proteolipid protein.
Further studies include a 3-month safety surveillance of these patients. If the results are successful, Apitope will continue with a Phase IIb proof-of-concept trial and then merge with a larger pharma company. Apitope’s approach is also geared against hypersensitivity reactions and the vaccine could hold promise for hemophilia as well as other autoimmune disorders.