After completing a successful phase I partnership with TFS International (TFS), Araclon Biotech a Grifols company, decided to continue the partnership with TFS advancing their Alzheimer’s disease (AD) vaccine ABvac40 into phase II.
The placebo-controlled phase II trial will be carried out at 21 clinical investigational sites across Europe over the next two years.
AD is a progressive disease associated with the accumulation, aggregation, and deposition of amyloid beta (Abeta) peptides in the brain. Abeta deposition may precede symptoms by many years. New therapies based on vaccines with active and passive immunizations against Abeta could effectively prevent Abeta deposition in the brain and, in some cases, even reverse the onset of dementia. Some trials with other AD vaccines failed to demonstrate any clinical benefit, and one of the reasons could be because they tried to attack plaques once they had already formed, which could be too late.
ABvac40 is an innovative, active immunotherapy that uses the C-terminal fragment of the amyloid-beta 40 peptide as an immunogen. This is a different approach to other AD vaccines, because the immunogen peptide of ABvac40 (Aβx-40) seems to be more relevant to the development of the disease than other peptides targeted by other vaccines. In the phase I study, the vaccine demonstrated a good safety and tolerability profile and produced an immune response in a high percentage of patients. In the phase II for ABvac40, of the 120 participants, some will have amnestic mild cognitive impairment (MCI) and some will have very mild AD, in order to evaluate the efficacy and safety at early stages of the disease, both at the cognitive and molecular levels.
This study was approved by the Spanish Agency of Medicinal Products and Medicinal Devices earlier this year.
“After establishing such a strong partnership with Araclon during the phase I programme, we are very pleased to have been chosen to collaborate in the phase II of this exciting and innovative new approach to the management of Alzheimer´s Disease through ABvac40 vaccine. One of our core values at TFS is ‘It’s All About Trust,’ and we are delighted that Araclon had the confidence to put their trust in TFS to take ABvac40 into phase II.”
Ed Tumaian, Vice President Clinical Development, TFS
About TFS International
TFS International is the leading, mid-size clinical Contract Research Organization (CRO) providing global clinical development solutions. Founded in 1996 in Sweden, TFS currently operates in 21 countries throughout Europe and North America and employs more than 700 professionals. TFS’ core therapeutic areas of expertise are Dermatology, Oncology, Ophthalmology, Immunology, CNS, Cardiology and Endocrinology. Through two business areas, TFS Develop™ and TFS People™, TFS provides services worldwide as end-to-end solutions or tactical functional services.
About Araclon Biotech, a Grifols company
Araclon Biotech is a Spanish company based in Zaragoza. They specialize 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).
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