Araclon & TFS to continue partnership, advancing Alzheimer’s vaccine to Phase II

After the successful completion of the Phase I trial, Araclon Biotech and TFS International have announced a continuation of their partnership to advance the trial of the Alzheimer’s disease (AD) vaccine ABvac40 into Phase II.

ABvac40 is an 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.

The Phase I study demonstrated a good safety and tolerability profile of the vaccine, which was also found to produce an immune response in a high proportion of patients. The second phase of clinical development will involve a 120 participants — some suffering from amnestic mild cognitive impairment (MCI) and some with very mild AD — and will evaluate the efficacy and safety at early stages of the disease, both at the cognitive and molecular levels. It will be a placebo-controlled trial that will be performed in 21 clinical investigational sites across Europe during the next two years.

“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,” said Ed Tumaian, vice president clinical development, TFS. “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.”

TFS International is a mid-size clinical contract research organisation (CRO) providing global clinical development solutions.

Araclon Biotech is a Spanish company based in Zaragoza. It specialises in researching and developing therapies and methods for diagnosing AD and other neurodegenerative diseases.