Chronology & Results
- Project kick-off meeting was held in Vienna on 8-10th October 2006.
- Progress of project and the path forward were presented and discussed at the occasion of regular bi-annual project meetings in Vienna 10/2006, Salzburg 03/2007, Blumau 10/2007, Marburg 04/2008, Vienna 09/2008, A Coruna 05/2009, Munich 10/2009, Graz 05/2010 and Vienna 12/2012.
- Preclinical milestones achieved based on the application of the AFFiRiS’ AFFITOME® technology:
- successful identification and evaluation of novel AFFITOPE®s directed against different Aß derivatives including pyro-glutamate modified Aß
- identification of several novel vaccine candidates which could reproducibly demonstrate the potential of altering disease progression in animal models of Alzheimer’s disease
- two novel patent families with several patents granted have been formed based on the candidates selected during MimoVax
- 2 candidates identified in this efficacy screening have also been tested successfully for safety, immunogenicity and tolerability in an extensive toxicologic program
- AFFITOPE® AD03 was identified as candidate for clinical testing
- Phase I testing of AFFITOPE® AD03
- Essential study documents were submitted to the Spanish Health Authority and the Ethics Committee in La Coruna/Santiago di Compostela in September 2009
- While the Ethics Committee approved the clinical protocol, Spanish Health Authority did not agree on the study
- Mimovax Consortium, led by AFFiRiS, selected an Austrian trial site for the phase I study
- submission to AGES, the Austrian Health Authority and the Ethics Committee in August 2010
- Study start in Austria in November 2010 (first patient first visit 30 Nov 2010)
- AFF005A, the phase I trial assessing repeated immunizations with AD03, was finished in December 2011 (final report). It met its primary endpoint.
- AFFITOPE® AD03 is the first drug that specifically targets pyroglutamated Aβ and successfully passed phase I clinical testing
Supported by the EC’s FP6 through Contract No. LSHB-CT-2006-037702