Grifols : The results of phase I clinical trial of the Araclon Biotech Alzheimer's vaccine support its continuation

• The conclusions of the trial were presented at the Alzheimer's Association International Conference in Toronto. The compound ABvac40, designed to combat Alzheimer's disease at its initial stage, has demonstrated a good safety and tolerability profile.
• This phase I blinded study did not evaluate the efficacy of the treatment. However, ABvac40 produced an immune response in more than 87% of patients who received the product during the trial.

Barcelona, August 1, 2016: Araclon Biotech, in which Grifols is the majority shareholder, has presented the results of the phase I clinical trial for its active immunotherapy against Alzheimer's disease (ABvac40) at the Alzheimer's Association International Conference (AAIC 2016), held in Toronto (Canada) from July 24 to 28, and organized by the American Alzheimer's Association.

The conclusions of this phase I blinded study were satisfactory and support the continuation of the development of ABvac40. The researchers confirmed that treatment with ABvac40 has a good safety and tolerability profile, and the company has started planning a clinical phase II.

A total of 24 patients with mild to moderate Alzheimer's disease participated in the phase I trial: 18 patients in the treatment group and 6 in the placebo/control group. There were no significant differences with respect to adverse effects between participants in the group that received ABvac40 and those in the placebo group.

Phase I of the ABvac40 clinical program focuses primarily on the tolerability and safety of the vaccine, but does not assess its effectiveness. However, the results have also confirmed that ABvac40 produced an immune response in more than 87% of patients who received the active principle during the clinical trial.

According to Manuel Sarasa, Scientific Director of Araclon Biotech: 'The results are very promising, although we still have a long way to go. We are still at a preliminary stage, and we must be cautious when evaluating the potential success of this project.'

Development of the vaccine is based on the immunization against the amyloid beta peptide. It is an innovative immunotherapy that acts specifically against amyloid beta protein 40 using the C-terminal part of the peptide.

Grifols, through Araclon Biotech, is pursuing another line of researchfocused on the early diagnosis of Alzheimer's disease. In particular, it has developed an early diagnostic test (ABtest) that makes it possible to detect and quantify different Aβ fractions. This test is available for research purposes.

At AAIC 2016, Araclon Biotech also has presented its ABtest Service, which completes the company's ABtest product line.

Araclon Biotech, a Grifols company

Araclon Biotech specializes in researching and developing therapies and methods for diagnosing Alzheimer's disease (AD) and other neurodegenerative diseases. This Grifols' company is currently focused on two lines of research: the early diagnosis of AD, through detection of beta-amyloid 40 and 42 peptides in blood, and treatment of the disease by immunotherapy (vaccine).