24 June 2008. Clinical testing of ACC-001, Elan’s second-generation Aβ vaccine, is back on track following a temporary suspension several weeks ago (see ARF related news story). In consultation with the FDA, Elan and Wyeth had suspended dosing after one patient developed a serious adverse event—then deemed to be vasculitis, or inflammation of the blood vessels, by onsite investigators. According to Andrew Lewis, Elan’s Director of Corporate Communications, the FDA lifted the hold after reviewing information furnished by the companies. They are now reinitiating dosing and recruitment (see ClinicalTrials.gov).
Elan’s first attempt at vaccine therapy failed when a small number of patients developed meningoencephalitis (see ARF related news story). This second-generation vaccine was designed to avoid inflammatory responses, and it is not quite clear what happened to that one patient with the adverse reaction. Subsequent biopsy and analysis showed that it was not vasculitis, according to Lewis, but the company had no further information to share at this time. Alzforum will continue to monitor trial progress and bring further updates as they become available. Elan and Wyeth also recently announced preliminary results of their passive immunotherapy, bapineuzumab, or AAB-001 (see ARF related news story).—Tom Fagan.