In the clinical phase I trial AFF001,AFFiRiS GmbH has now recruited the 24 Alzheimer patients planned for thistrial. The trial aims to investigate the tolerability and safety of aninnovative Alzheimer's vaccine (AFFITOPE AD01). In the trial, all patientshave now been vaccinated at least once and have so far tolerated the vaccineextremely well. The treatment provides for four vaccinations administered atmonthly intervals and is due to be fully completed by this October. Thevaccine's tolerability can then be conclusively evaluated. So far theresults indicate good tolerability for this Alzheimer's vaccine from AFFiRiSGmbH. It is on this basis that recruitment of further patients has alreadybegun for the clinical trial of a second Alzheimer's vaccine by AFFiRiS.
Vienna-based AFFiRiS GmbH has announced the successful completion of patientrecruitment for clinical phase I testing of its Alzheimer's vaccine AD01.The vaccine is being administered at the Vienna General Hospital (AKH) to 24Alzheimer's patients at a mild to moderate stage of the disease. Thepatients are being vaccinated a total of four times over a three-monthperiod. During this time, and over a further two months, the safety andtolerability of the vaccine is being investigated. A professional carenetwork with the highest medical standards ensures the patients' health andwell-being.
Commenting on the planned progression of the trial, Dr. Walter Schmidt, CEOof AFFiRiS GmbH says: "We have now treated the maximum number of patientsfor the first time. After the end of the trial in a few months' time, wewill know whether the impression so far of our vaccine's good tolerabilityis confirmed. As patient interest in the last few months has grownsignificantly, we are delighted that we are already in a position to offerparticipation in clinical testing of our second Alzheimer's vaccine,AFFITOPE AD02. The support from our largest investor, MIG-Fonds, is crucialin this regard, as only sound financing enables this rapid progression inclinical studies."
The Alzheimer's vaccines developed by AFFiRiS are based on AFFITOMEtechnology developed in-house, which functions using the mimotope principle.This technology enables the development of customized vaccines known asAFFITOPE. Dr. Schmidt explains the special features of AFFiRiS's approach tothe Alzheimer's vaccine: "Alzheimer's is caused by beta-amyloid, an unwantedfragment of one of the body's own proteins that occurs on the surface ofbrain cells. Development of a successful vaccine is extremely challenging asit is vital to ensure that antibodies only attack beta-amyloid if it occursseparated in the brain fluid but not as long as it is still part of thenormal APP protein on the brain cells. The brain cells would otherwise beattacked. Thanks to AFFITOME technology, we are in the unique position ofbeing able to safely protect the brain cells and only combat thedisease-causing beta-amyloid."
AFFITOME technology patented by the company enables scientists to createboth molecules with very specific binding characteristics and molecules thatdiffer in structure but exhibit identical binding characteristics. Thesestrengths are now being used in developing the AD01 and AD02 vaccines, bothof which align the immune system against the same beta-amyloid structure.However, AFFITOME technology can also be used to have a positive influenceon other human rogue proteins - such as lipid metabolism enzymes.Consequently, an appropriate development by AFFiRiS could provide aneffective treatment for atherosclerosis.
Michael Motschmann, Senior Fund Manager at MIG-Fonds, explains his views onthis development by AFFiRiS GmbH: "The company specialises in thedevelopment of treatments for diseases that urgently require a medicalsolution and also offer attractive market potential. With 22 millionsufferers predicted for 2025 and no effective treatment, Alzheimer's is onesuch disease. The second disease that AFFiRiS has chosen to tackle isatherosclerosis, where a tailor-made vaccine is also under development. Thecompany's development pipeline is already full, with the business model which we support in full - envisaging a new product entering clinicaltesting every two years."