AFFiRiS reaches milestone in clinical trial of Alzheimer's vaccine
In the clinical phase I trial AFF001, AFFiRiS GmbH has now recruited the 24 Alzheimer patients planned for this trial. The trial aims to investigate the tolerability and safety of an Alzheimer's vaccine (AFFITOPE AD01). In the trial, all patients have now been vaccinated at least once and have so far tolerated the vaccine extremely well. The treatment provides for four vaccinations administered at monthly intervals and is due to be fully completed by this October. The vaccine's tolerability can then be conclusively evaluated. So far the results indicate good tolerability for this Alzheimer's vaccine from AFFiRiS GmbH. It is on this basis that recruitment of further patients has already begun for the clinical trial of a second Alzheimer's vaccine by AFFiRiS.
Commenting on the planned progression of the trial, Dr. Walter Schmidt, CEO of AFFiRiS GmbH says: "We have now treated the maximum number of patients for the first time. After the end of the trial in a few months' time, we will know whether the impression so far of our vaccine's good tolerability is confirmed. As patient interest in the last few months has grown significantly, we are delighted that we are already in a position to offer participation in clinical testing of our second Alzheimer's vaccine, AFFITOPE AD02. The support from our largest investor, MIG-Fonds, is crucial in this regard, as only sound financing enables this rapid progression in clinical studies."
The Alzheimer's vaccines developed by AFFiRiS are based on AFFITOME technology developed in-house, which functions using the mimotope principle. This technology enables the development of customized vaccines known as AFFITOPE. Dr. Schmidt explains the special features of AFFiRiS's approach to the Alzheimer's vaccine: "Alzheimer's is caused by beta-amyloid, an unwanted fragment of one of the body's own proteins that occurs on the surface of brain cells. Development of a successful vaccine is extremely challenging as it is vital to ensure that antibodies only attack beta-amyloid if it occurs separated in the brain fluid but not as long as it is still part of the normal APP protein on the brain cells. The brain cells would otherwise be attacked. Thanks to AFFITOME technology, we are in the unique position of being able to safely protect the brain cells and only combat the disease-causing beta-amyloid."
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