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Home: Drug Development: Drugs in Clinical Trials
Drugs In Clinical Trials

Important Notice: The Forum does not endorse any medical product or therapy. ALL medications and supplements should be taken ONLY under the supervision of a physician, due to the possibility of side-effects, drug interactions, etc.

Name: Affitope AD02
Other Names: Mimotope Aβ(1-6)
Therapeutic Applications: Mild to moderate Alzheimer Disease
Therapy Types: Protein: active immunization, peptide vaccine
Mechanisms: Aβ(1-6) immunotherapy
Development Status: investigational outside U.S.
FDA Phase: Phase II/IIa/IIb
Role in Alzheimer's Disease: Affitope AD02 is a short amino-terminal Aβ fragment (Aβ1-6) that is derived from the N-terminal B cell epitope of Aβ while avoiding T cell activation (reviewed in Lemere and Masliah 2010). This immunogen thus potentially avoids the safety concerns associated with AN1792 vaccine (Aβ1-42) which presented residues Aβ15-42, the most common T cell epitope, the most likely cause of Th1 lymphocyte activation and therefore predominantly responsible for autoimmune meningoencephalitis. At the Global Vaccine Research Forum 2008, Achim Schneeberger of Affiris presented preclinical mouse data demonstrating that Affitope induced antisera stained plaques but not APP on cells and was effective in reducing total plaque area with accompanying reductions in astrocytic foci, microgliosis. (See Schneeberger 2008).
Companies: AffiRiS AG, GlaxoSmithKline
Notes: Phase I safety/tolerability, immunological and clinical study of Affitope AD02 is ongoing (See NCT01093664). A Phase II interventional trial has been announced but is not yet open for participant recruitment, and will be located at approximately 30 study sites in Europe. (See NCT01117818).

This record was updated September 29, 2010.


References

Lemere CA, Masliah E. Can Alzheimer disease be prevented by amyloid-beta immunotherapy? Nat Rev Neurol. 2010 Feb;6(2):108-19. Review. Erratum in: Nat Rev Neurol. 2010 Apr;6(4):183. Nat Rev Neurol. 2010 Jun;6(6):296. POW Link


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