- After receiving approval from the Spanish Agency of Medicinal Products and Medical Devices
-A total of 120 patients with mild cognitive impairment (MCI) from 22 European facilities will participate in phase II of the clinical trial.
-This phase of the study is designed to establish the dosage regimen for the therapy, as well as confirm the treatment safety and tolerability data obtained in phase I.
ZARAGOZA, Spain, June 27, 2017 /PRNewswire/ -- Araclon Biotech, in which Grifols holds a majority stake, has received approval from the Spanish Agency of Medicinal Products and Medical Devices to begin phase II clinical trials for its active immunotherapy for Alzheimer's disease (ABvac40).
The company expects this phase II study to take place over the next two years, with 120 patients diagnosed with the very early stages Alzheimer's participating. These are individuals who have not yet developed symptoms of dementia who are referred to in a clinical context as prodromal patients, or patients with mild cognitive impairment (MCI). Half of the participants will receive the active substance and the other half (the control group) will receive a placebo.
The phase II ABvac40 study will be carried out at 22 facilities in various European countries, with 18 centers in Spain, 2 in France, 1 in Sweden, and 1 in Italy. The recruitment process is expected to begin in July in some of the selected facilities.
The objectives of this phase II study are to establish the dosage of the product to be administered in subsequent phases and increase the treatment safety and tolerability data obtained in phase I. Results from phase I, presented in July 2016, demonstrated good profiles in both respects, and confirmed that ABvac40 produced an immune response in more than 87% of participants who received the active ingredient.
This phase II study, in addition to increasing the safety data, is designed to evaluate response on the cognitive and molecular levels.
ABvac40 is an innovative active immunotherapy that uses the C-terminal fragment of the amyloid-beta 40 peptide as an immunogen, which is a different approach from the rest of the therapies that are currently in the clinical development phase.
Araclon Biotech is also pursuing another line of research focused on the early diagnosis of Alzheimer's disease and has developed ABtest Service, which makes it possible to detect and quantify certain Aβ variants in different plasma fractions. This test is already available for use in research, and in years to come, once the results from current studies are obtained, is expected to be extremely helpful in identifying people at risk of suffering from Alzheimer's disease, allowing them to receive preventative treatment to impede its development.
About Alzheimer's disease
Alzheimer's disease is a neurodegenerative disease characterized by the death of neurons in the brain. Currently incurable, it is considered to be a genuine 21st-century epidemic that will affect increasing numbers of elderly people in the world's most developed countries.
This illness, which involves deterioration in memory, intellect, behavior, and the ability to carry out regular activities, is the most common cause of dementia and has a psychological, physical, social, and economic impact on caretakers, society, and the health care system.
According to the Alzheimer's Association in the U.S., the disease affects 5.5 million Americans, more than 96% of whom are over the age of 65. The association estimates that the number of people affected in the U.S. will surpass 16 million by 2050. Meanwhile, the WHO estimates that there are currently some 47.5 million people worldwide suffering from dementia. Alzheimer's disease represents between 60% and 80% of these cases, and experts anticipate that in 2050, there could be more than 135 million sufferers throughout the world.
Spain's figures are similar to those in neighboring countries. According to estimates from the Spanish National Epidemiology Center, 7.3% of the population over the age of 65 may currently be suffering from this disease, and the number of patients could reach around one million people in 2050.
About Araclon Biotech, a Grifols company
Araclon Biotech specializes in researching and developing therapies and diagnostic methods for Alzheimer's disease (AD) and other neurodegenerative diseases. The company, in which Grifols holds a majority stake, focuses on two research areas: the early diagnosis of AD by means of detecting amyloid-beta peptides in the blood, and the treatment of the disease using immunotherapy (vaccines).
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