Grifols achieves ten years of research into Alzheimer's


15.09.2014

  • By the end of 2015 Grifols plans to present the interim results of the AMBAR (Alzheimer Management By Albumin Replacement) study, its phase III clinical trial that combines the extraction of plasma and its replacement with a solution of albumin, the most abundant protein in the blood plasma
  • In the last ten years Grifols has carried out two successful clinical trials that demonstrated the mobilization of beta-amyloid peptide in the blood of patients. AMBAR will allow us to confirm the tendency towards stabilization of the disease and to an improvement in the cognitive functions found in previous studies.
  • Grifols' research extends to the field of early diagnosis and prevention with projects developed by its company Araclon Biotech

 

Barcelona, September 15, 2014.-Grifols, the world's third largest manufacturer of plasma-derived biological medicines and a pioneer in the research and development of therapeutic alternatives designed to contribute to both scientific and social development, has been conducting research into Alzheimer's for ten years.

Over the last decade, Grifols has developed a comprehensive research strategy that comprises three fields: the development of new treatments with plasma proteins (mainly albumin) aimed at slowing the progression of the disease; diagnosis in asymptomatic stages; and prevention through the development of vaccines. This strategy is developed directly by Grifols and also through Araclon Biotech, a company that belongs to the group.

A new focus on the treatment of Alzheimer's: the AMBAR study (Alzheimer Management By Albumin Replacement) 

A decade ago, the different lines of research that Grifols pursued in relation to plasma and plasma proteins prompted its possible use in Alzheimer's disease. Currently, one of its lines of research focuses on a combined therapy of plasma extraction and replacement with albumin, the most abundant protein in plasma, whose main function is to transport substances through the bloodstream, including toxic elements in the body.

Grifols approach stems from the idea that the pathology of AD is related to the presence of so-called senile plaques and neurofibrillary tangles in the regions of the brain involved in memory. These plaques are mainly composed of the beta-amyloid (Aß) peptide and a large part of Aß peptide circulating in the blood is bound to albumin.

The AMBAR study is based on the hypothesis that by removing plasma with the Aß peptide bound to albumin by means of a process called plasma exchange y substituting this with Grifols Albumin, it will be possible to clear the Aß peptide from the brain into the plasma which would lead to an improvement in the patient's cognitive functions. In addition the AMBAR study will test a particular type of low-volume plasmatic exchange called hemapheresis. Furthermore, if there are other substances in plasma involved in the genesis of AD, this technique would also remove them from circulation.

This is an international multicenter study involving a total of 365 patients with moderate mild-stage Alzheimer's disease, divided randomly into three treatment groups, plus a fourth control group, at 21 hospitals in Spain and 22 in the United States. As of July 2014, more than 50 patients were already taking part in the study and Grifols plans to present interim results at the end of 2015. 

Grifols comprehensive research strategy includes preclinical diagnosis and prevention

The diagnosis of the disease in the asymptomatic stages (before the patient develops symptoms) is considered increasingly important for the design of new clinical trials and the search for therapeutic solutions. Diagnosis currently occurs in advanced stages of the disease.

Through Araclon Biotech, Grifols has developed an early diagnostic test (ABtest) for Alzheimer's that is available in the field of specialized research.

The ABtest allows the detection and quantification of different beta-amyloid (Aß) peptides regarded as biomarkers for preclinical diagnosis of disease.

Araclon Biotech will in fact use the ABTest to analyze blood samples from 1,500 participants in the study launched by the largest research group in dementias in the world: the United Kingdom Dementias Research Platform (UKDP). The study aims to characterize more than 2 million asymptomatic stage individuals.

In the longer term, Araclon Biotech is also working on the development of a vaccine to combat Alzheimer's disease in the asymptomatic/preclinical stages. The clinical trial for the vaccine is currently in phase I, which mainly assesses the safety and tolerability (never the effectiveness), and the first patients have already been selected. 

About Alzheimer's disease

Alzheimer's disease is a neurodegenerative disease characterized by the death of neurons in the brain. Alzheimer's disease currently has no cure, and is viewed as a 21st century epidemic, that will have a devastating effect on the elderly population in developed countries.

According to the Alzheimer's Association, the disease affects 10% of those aged over 65, and up to 25% of people aged over 85, although only between 2% and 7% of cases are diagnosed in the early stages.

The World Health Organization estimates that 24.3 million people currently suffer Alzheimer's disease, with an increase of 4.6 million new cases each year. In the year 2011, in the United States alone, there were approximately 5.4 million patients, and it is estimated that by 2050 there could be between 11 and 16 million. In Spain the situation is similar to surrounding countries. In 2010 the prevalence of the disease was estimated at approximately 500,000 diagnosed cases according to the Centro Nacional de Epidemiología. However due to the progressive aging of the population, the number of patients could increase by 75% by the year 2030.