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Alzheimer’s vaccine will be tested on humans at the end of 2010

Araclon Biotech has obtained its first European Patent for a vaccine therapy for Alzheimer’s disease. The company hopes to start the regulatory pre-clinical development of the vaccine this year, with the aim of starting clinical trials on humans at the end of 2010.

The conclusions obtained concerning toxicity and efficacy in the animal models used has encouraged the company’s high expectations for future clinical results. Receiving the patent in the European Union, granted by the European Patent Office is a big break for the company’s ambitious project.

Araclon_BiotechDoes this step mean that this remedy can be used? No, not yet. Until now, researchers, led by Dr. Manuel Sarasa, Professor of Anatomy and Comparative Pathology of the University of Zaragoza, have used animal models, mainly dogs. “Dog reproduces quite well Alzheimer’s injuries in human beings and because of that we chose it”, Pilar de la Huerta, Araclon Biotech executive advisor, pointed out.

“This is the first vaccine developed in Spain as a therapy for this disease and one of the few in the world”, Sarasa, who has been studying Alzheimer for twenty years, added.

However, although it is very difficult to foresee the efficiency that this therapy will have in human beings, the truth is that in animal experimentation it is 100%.

To achieve this, several antibodies, which have led to this vaccine, were developed and patented. At the moment, researchers are very optimistic with the future. ‘Other companies have developed vaccines that, when they passed to the testing-in-humans phase, were effective but toxic, so they could not be used’ - Pilar de la Huerta explains -. ‘Nonetheless, our studies show that this one, at the moment, is not”.

Professor Sarasa’s last discoveries show that Amyloid-Beta protein, which is related to the disease, is not only in senile plaques but also in neurofibrillary tangles. The objective of the vaccine is to go directly to the molecule, which is considered the cause of the disease, and reduce its levels. This is a bet to the detriment of other solutions as enzymes inhibiting therapies.

On the other hand, this team thinks that the mistake of previous researches to heal the disease has been that they chose persons who already had the problem. Because of that, they want to begin testing with healthy volunteers.

Araclon_Biotech_professionalsAraclon Biotech was founded in 2004 by Professor Manuel Sarasa and after two years began to work with the help of investors. Dedicated to the research and development of therapies and diagnostic methods of degenerative diseases, nowadays it focuses on Alzheimer’s disease.

The company, which has its main laboratories at the Montecanal Clinic of Zaragoza and in Logroño, develops other lines of research. For example, a diagnostic kit for the disease that, with a blood sample, allows detecting and quantifying 40 and 42 Amyloid-Beta proteins (related to Alzheimer) with a higher sensibility than the one it was being achieved. After initial studies, the forecast is that this year it might begin to be sold in Spain as a kit.

Specifically, between 2008 and 2010, the company plans to invest around 12 million euros in I+D in their three lines of research: development and perfecting of the diagnostic kit for the disease, efficient therapy for Alzheimer (vaccine) and development of a predictive kit for this pathology.

According to the 2007 Annual Report from the Spanish Association of Bioenterprises (ASEBIO), of the 639 patents conceded to Spanish biotech companies in 2007, 85% were Spanish patents and the remaining 15% were from the U.S.A., but none were European Patents. These figures show us the important of this Patent for Araclon Biotech and for the biotechnology sector in Spain.

The vaccine having received the European Patent has already received the Patent in Spain and other markets outside the E.U. Araclon Biotech trust that it will soon also obtain the patent in the United States, the leading market in the world. The biotechnology company is currently involved in more than thirty international proceedings for obtaining patents.



COGKNOW is funded by the European Comission within the IST-2005/2006-2.5.11 (Unit H3 - eInclusion) Contract #034025

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