As AFFiRiS AG's clinical Alzheimer's vaccine candidate AD02 has already progressed to phase-II clinical testing, it may be possible to confirm the efficacy of the vaccine as early as during 2012, according to a report.
The start of this efficacy study comes five months after the completion of the corresponding phase-I study. The company which is active in several disease areas is currently developing a total of 12 prospective products in all stages of the development pipeline up to clinical phase-II.
The prospective Alzheimer's vaccine AD02 by AFFiRiS AG will with immediate effect be used in a multicentre phase-II clinical study in Austria and five other European countries. Clinical centres in Germany, France, the Czech Republic, Slovakia and Croatia are taking part in the study. A total of 420 patients will be recruited.
During the past year the safety and tolerability of the vaccine has been confirmed; now the focus is on its efficacy. According to CEO and co-founder of the company Dr Walter Schmidt "Last year AD02, along with our second prospective Alzheimer's vaccine AD01, was primarily tested in terms of its safety and tolerability. Those primary endpoints have been met by vaccine formulations. The decision to nominate AD02 for phase-II testing study is based on currently still confidential results of the interim analysis of the secondary endpoints of the preceding phase-I studies.”
The other reason for deciding to accelerate the progress of AD02 is the company's principle to set clear priorities in respect of its broad product pipeline. The pipeline also comprises vaccines for treating atherosclerosis, hypertension and three other indications, which are currently still confidential. In addition, AFFiRiS AG announced only a few weeks ago that a prospective vaccine for the treatment of Parkinson's disease will start phase I clinical studies at the beginning of 2011.
With regard to the extent of the development pipeline ,CSO Dr Frank Mattner said, "Even before the start of the company's first phase-II study we were able to build up a very broad product pipeline. This success is based on two components: our Affitome technology and our solid financial basis. The Affitome technology is increasingly proving itself to be more than an ideal platform technology for our product developments. It provides innovative solutions for the therapeutic treatment of chronic diseases with unmet medical need and opens up attractive markets for us. Our investors, the MIG Fonds, had already recognised this potential four years ago. In this way they assured us of early and substantial financing, which has contributed decisively to the rapid and successful progress of our development projects.”
On the basis of the company's own patents, AFFiRiS develops tailor-made peptide vaccines against Alzheimer's disease, atherosclerosis, Parkinson's disease hypertension and four other conditions with an urgent medical requirement and attractive market volumes.