July 3, 2012

Grifols launches AMBAR study, based on the combined use of plasma derivatives and plasmapheresis to treat Alzheimer's disease

The new AMBAR study combines therapeutic plasmapheresis with alternating infusion of albumin and intravenous immunoglobulin (IVIG) to treat Alzheimer's

  • The new AMBAR study combines therapeutic plasmapheresis with alternating infusion of albumin and intravenous immunoglobulin (IVIG) to treat Alzheimer's
  • This clinical study will also validate a prototype plasmapheresis centrifuge developed with Fenwal to make the process more comfortable for the patient

Barcelona, July 2 2012 Grifols, the world's third-largest plasma derivatives company and a pioneer in the research and development of therapeutic applications of plasma proteins, has launched a study into the treatment of Alzheimer's disease (AD) involving around 350 patients. The AMBAR study ("Alzheimer Management By Amyloid Removal") trials combined treatment with albumin plasmapheresis and intravenous immunoglobulin (IVIG) at different doses. The study seeks to identify synergies between the two treatments, with the aim of reducing both the frequency and the volume of plasmapheresis, to make the treatment experience more pleasant for the patient and easier for medical staff to administer. Grifols has worked with the American company Fenwal to develop the prototype of a plasmapheresis machine specially adapted to meet this requirement, which will be validated as part of the study.

This multi-center study will be conducted in hospitals in Spain and the United States and will include Alzheimer's patients at the mild to moderate stage of the disease, randomly grouped into three treatment branches and a fourth control group. The estimated duration of the study is two years. AMBAR will be directed by Dr. Mercè Boada, medical director of Fundació ACE and clinical head of the Neurology Service of the Vall d'Hebron Hospital in Barcelona. Dr. Boada explains that, "this study is the fruit of over five years of research that have produced encouraging results, with patients receiving prior treated maintaining cognitive stability throughout the study period and achieving positive ADAS-cog scores." And she goes on to say that, "the AMBAR study opens up new prospects and hopes in dealing with an illness where success involves maintaining the quality of life of these patients." She adds that, "despite the complexity of the study, the principal investigators are really keen to take part because they are aware that there are no simple treatments for Alzheimer's. They enjoy the challenge of offering new alternatives to patients and their families."

The CEO of the company, Víctor Grifols, explains, "in this study we have paid particular attention to reducing the discomfort associated with treatment. Both the plasmapheresis machine and alternate infusion of albumin and immunoglobulin will contribute to this."

Results of the preliminary study

In September 2009, Grifols published partial results - in 29 patients out of a total of 42 - of a preliminary trial conducted in two hospitals in Spain and two in the United States, showing a tendency for the disease to stabilize. The complete results of the preliminary trial were presented at the 8th Barcelona-Pittsburgh Biennial Conference "Dementia today" (May 23-25, 2012, Barcelona) organized by the Fundació ACE, Barcelona Alzheimer Treatment & Research Center (Dr. Mercè Boada) and the Alzheimer Research Center of the University of Pittsburgh (Dr. Óscar López) before an international audience of 400 delegates.

About Alzheimer's disease

Alzheimer's disease is viewed as an epidemic of the 21st century, destined to affect the elderly population in the developed world. 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 at the early stages.

In the United States alone, there are about 5.4 million patients, and it is estimated that by 2050 there could be some 15 million. At the same time, the direct and indirect health costs associated with caring for these patients amounts to 200,000 million dollars per year.1

The prevalence of the disease in Spain is currently estimated at between 350,000 and 380,000 cases, according to the team led by Dr. Jesús de Pedro of Spain's National Epidemiology Center. Expenditure linked to dementias, including AD, totaled approximately 14,000 million euros per year in 2010 (18,000 million dollars)2

About Grifols

Grifols is the world's third largest producer of plasma derivatives by capacity and is the sector's largest European company, with a balanced and diverse range of products. The group will strengthen its position within the industry as a vertically integrated company, on the basis of its completed and additional planned investments. In terms of raw material, Grifols is the leading plasma collection company, with supplies assured via its network of 147 plasmapheresis centers in the United States. Its production plants in Spain and the United States ensure that it has the fractionation capacity to satisfy rising demand for plasma derivatives.

12012 Alzheimer's Disease Fact and Figures (http://www.alz.org/documents_custom/2012_facts_figures_fact_sheet.pdf)

2 Data from the study "Alzheimer's & Dementia 6 (2010) 98-103" conducted by the Karolinska Institutet-Alzheimer's Disease Research Center and i3 Innovus (Sweden)