ATHENS, Greece I March 18, 2016 I AXON Neuroscience presented two topics from its disease modifying AD program at the 14th International Athens/Springfield Symposium on Advances in Alzheimer Therapy. In the first presentation Axon introduced the endpoints and the design of the phase II clinical trial with the first active tau vaccine, AADvac1, in patients with mild Alzheimer’s disease. In the second presentation, AXON presented the immunology profile of AADvac1 from the successful Phase I study which was performed in Austria with 30 patients at 4 clinical sites
AADVAC1 PHASE II CLINICAL STUDY
AXON’s active vaccine AADvac1 is intended to be a disease-modifying drug for Alzheimer’s disease. AXON has previously demonstrated positive results of preclinical research with a significant reduction of tau pathology in transgenic animal models and improvement of their survival and neurobehavioral symptoms. The Phase I study in humans has confirmed that AADvac1 is safe and well tolerated. It induced a robust immune response and the cognition of the patients remained on average stable for the whole duration of the Phase I study.
At the Springfield Symposium, AXON’s Medical Director, Matej Ondrus, highlighted the above mentioned results as an excellent starting point for designing the Phase II clinical study. This study aims to confirm the proof-of-concept in a larger patient population. He presented the study design powered for both the primary endpoints of safety and tolerability and a secondary endpoint of efficacy in mild Alzheimer’s disease patients. The study will assess 185 randomized subjects in 7 countries of Europe with an overall study duration of 24 months.
After the presentation, Matej Ondrus added: “We are excited to present the official start of the Phase II study with the first patient already screened on March 9th, 2016.”
AADVAC1 IMMUNOLOGY PROFILE
Norbert Zilka, Chief Science Officer of AXON Neuroscience presented results on the excellent immunological profile of the AADvac1 vaccine in Phase I clinical trial. The study demonstrated that more than. 80% of the vaccine responders generated titers higher than 1:10,000. AADvac1 is the first vaccine against AD that was able to overcome the low antibody responsiveness typically seen in elderly people.
AXON NEUROSCIENCE
AXON Neuroscience is a biotech company with a mission to deliver disease-modifying treatment for patients suffering from Alzheimer’s disease and other tauopathies.
SOURCE: Axon Neuroscience
Post Views: 214
ATHENS, Greece I March 18, 2016 I AXON Neuroscience presented two topics from its disease modifying AD program at the 14th International Athens/Springfield Symposium on Advances in Alzheimer Therapy. In the first presentation Axon introduced the endpoints and the design of the phase II clinical trial with the first active tau vaccine, AADvac1, in patients with mild Alzheimer’s disease. In the second presentation, AXON presented the immunology profile of AADvac1 from the successful Phase I study which was performed in Austria with 30 patients at 4 clinical sites
AADVAC1 PHASE II CLINICAL STUDY
AXON’s active vaccine AADvac1 is intended to be a disease-modifying drug for Alzheimer’s disease. AXON has previously demonstrated positive results of preclinical research with a significant reduction of tau pathology in transgenic animal models and improvement of their survival and neurobehavioral symptoms. The Phase I study in humans has confirmed that AADvac1 is safe and well tolerated. It induced a robust immune response and the cognition of the patients remained on average stable for the whole duration of the Phase I study.
At the Springfield Symposium, AXON’s Medical Director, Matej Ondrus, highlighted the above mentioned results as an excellent starting point for designing the Phase II clinical study. This study aims to confirm the proof-of-concept in a larger patient population. He presented the study design powered for both the primary endpoints of safety and tolerability and a secondary endpoint of efficacy in mild Alzheimer’s disease patients. The study will assess 185 randomized subjects in 7 countries of Europe with an overall study duration of 24 months.
After the presentation, Matej Ondrus added: “We are excited to present the official start of the Phase II study with the first patient already screened on March 9th, 2016.”
AADVAC1 IMMUNOLOGY PROFILE
Norbert Zilka, Chief Science Officer of AXON Neuroscience presented results on the excellent immunological profile of the AADvac1 vaccine in Phase I clinical trial. The study demonstrated that more than. 80% of the vaccine responders generated titers higher than 1:10,000. AADvac1 is the first vaccine against AD that was able to overcome the low antibody responsiveness typically seen in elderly people.
AXON NEUROSCIENCE
AXON Neuroscience is a biotech company with a mission to deliver disease-modifying treatment for patients suffering from Alzheimer’s disease and other tauopathies.
SOURCE: Axon Neuroscience
Post Views: 214
