March 22, 2018

Grifols concludes the experimental phase of AMBAR, a clinical trial on Alzheimer's disease

Grifols initiated its Alzheimer's research in 2004

  • Grifols begins the collection and evaluation process of data gathered from the 496 patients enrolled in the trial
  • AMBAR (Alzheimer Management By Albumin Replacement) aims to evaluate whether Alzheimer's disease can be stabilized by periodically extracting plasma and replacing it with albumin (Albutein®), a process known as "plasma exchange"
  • Data collection and analysis are especially complex given the randomized and double-blind design of the study, so Grifols does not expect to communicate the trial's results until the fourth quarter of 2018

Barcelona, March 22, 2018.- Grifols (MCE:GRF, MCE:GRF.P y NASDAQ:GRFS), one of world's top three producers of plasma-derived medicines, makes inroads in its research efforts to find a treatment for Alzheimer's disease. The 496 patients enrolled in the AMBAR (Alzheimer Management By Albumin Replacement) clinical trial have finished treatment according to schedule. Thus ends the experimental phase of the trial, giving way to data collection and evaluation and analysis of the results, which the company plans to announce in the fourth quarter of 2018.

United BioSource Corporation LLC, an independent contract research organization (CRO) based in Blue Bell, Pennsylvania, oversaw the trial's clinical monitoring phase and will continue on to manage the data collection and analysis stages. The trial employed a randomized and double-blind design, meaning that neither patients nor researchers knew whether subjects were receiving the treatment or the placebo. Data collection and information analysis for this type of trial design are far more complex and prolonged compared to studies with simpler designs.

AMBAR is an international and multi-center clinical trial that included 496 patients with mild to moderate Alzheimer's disease across 41 hospitals (20 in Spain and 21 in the United States). Patients were randomly assigned to four groups: three treatment groups and a control group.

Among the participating centers of reference is the Fundación ACE in Barcelona, Spain. The center is directed by Dr. Mercè Boada, who collaborated in the design of the clinical trial.

AMBAR aims to evaluate whether the progression of Alzheimer's can be stabilized through plasma exchange, a process that entails periodically extracting plasma and replacing it with albumin solution (Albutein®). This treatment is based on the hypothesis that most of the amyloid-beta protein—one of the proteins that accumulate in the brain of Alzheimer's patients—is bound to albumin and circulates in plasma. Extracting this plasma might flush amyloid-beta peptide from the brain into the plasma, thus limiting the disease's impact on the patients' cognitive functions.

The trial generated an immense body of data and patient allocation in the various treatment groups will remain unknown until the analysis process has concluded. For this reason, Grifols does not foresee having AMBAR results until the fourth quarter of 2018.

The company began its research on Alzheimer's disease in 2004 with several pre-clinical trials, two pilot studies and a Phase II clinical trial before launching the AMBAR trial.

About Alzheimer's Disease

Alzheimer's disease is a neurodegenerative pathology characterized by the death of neurons in the brain. Described as a 21st-century epidemic, it currently has no cure and its prevalence is expected to rise, especially among elderly populations in developed countries.

The most common cause of dementia, Alzheimer's causes memory loss, intellectual impairment, behavioral change, and the inability to perform daily tasks. It also has a major psychological, physical, social and economic impact on caretakers, society, and healthcare systems.

The World Health Organization (WHO) estimates that nearly 50 million people currently suffer from Alzheimer's disease, with around 8 million new cases diagnosed each year. Alzheimer's disease is the leading cause of dementia, accounting for 60 and 80 percent of all cases. Experts predict that more 75 million people will be affected with Alzheimer's by 2030, and over 135 million by 2050.