Date: 2014-01-09
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: AC Immune (Switzerland)
Product: anti-pTau vaccine ACI-35
Action
mechanism: ACI-35 is an active vaccine, discovered by AC Immune, stimulating the patient\'s immune system to produce conformation-specific antibodies against phosphorylated Tau protein. The phospho-Tau protein forms twisted fibers inside neuronal cells and builds tangles that are considered to be one of the two hallmarks of Alzheimer’s disease, besides Abeta-plaques. During pre-clinical development, ACI-35 showed reduction of phospho-Tau aggregates and total pathological Tau and improvement of clinical parameters. The vaccine ACI-35 is also characterized by very specific antibody response against pathological Tau and its T-cell independent immune response, an important feature of AC Immune’s SupraAntigen technology platform, supporting the excellent safety profile.
Disease: Alzheimer’s disease
Therapeutic area: Neurodegenerative diseases
Country:
Trial
details: The clinical trial is a Phase I, randomized, double blind, placebo controlled clinical study with the primary objective of evaluating the safety, tolerability and immunogenicity of ACI-35. Secondary objectives will assess relevant biomarkers and functional and clinical parameters. Two groups of patients with mild or moderate Alzheimer’s disease will receive a different dose of ACI-35. Patient safety in the study has been secured by careful planning and extensive preclinical tests.
Latest
news: * On January 9, 2014, AC Immune has announced it has started the world’s first trial of a vaccine against the phospho-Tau target for Alzheimer’s disease.
