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Biotechnology companies Advancell and Neurotec Pharma, both based in the Barcelona Science Park (PCB), have begun Phase IIa clinical trials on NT-KO-003, an oral multiple-sclerosis treatment that works in a completely different way from those currently used to combat the disease.

The clinical trial, called NeuroAdvan, will be conducted on 105 patients from 11 public hospitals in Spain (4 of them in Catalonia) and 3 in Germany. It will be led by Dr. Pablo Villoslada, head of Neuroimmunology at IDIBAPS-Barcelona Hospital Clínic. The project is also collaborating with the MRI Analysis and Research Center in Neuroimaging and Multiple Sclerosis (CARM) at the Vall d'Hebron Hospital, led by Dr. Alex Rovira, and also receives guidance from Dr. Rafael Arroyo at the San Carlos Clinical Hospital in Madrid and Dr. Xavier Montalban from Vall d'Hebron Hospital. Results from the study are expected in late 2012.

Multiple Sclerosis affects about 30,000 people in Spain and 2.5 million worldwide, according to data from the Multiple Sclerosis Society of Spain and the World Health Organization (WHO). Drugs currently used to treat MS are immunomodulators, which have significant side effects, limited efficacy and require parenteral administration (intravenous or subcutaneous). In animal models during the preclinical phase, NT-KO-003 was shown to have anti-inflammatory and neuroprotective effects, rather than an immunosuppressive effect. Consequently, it could be combined with other drugs and administered to nearly all patients affected by the disease. It is also one of the first oral treatments that could potentially slow the progression of multiple sclerosis and reduce the neurological damage it causes.

Due to its neuroprotective action mechanism, Advancell and Neurotec are exploring the possibility of using NT-KO-003 to treat other neuromuscular diseases, such as amyotrophic lateral sclerosis.

€2.2 millions in investments will be required for this clinical trial and the Catalan biotech firms will receive support from the Government of Catalonia, through the ACC1Ó Technology Innovation Hubs program, and the Ministry of Science and Innovation, through the Innpacto subprogram of the 2008-2011 National Plan for Scientific Research, Development and Technological Innovation. The total cost of developing NT-KO-003 is about €4 millions, with an estimated potential market of around €5,300 millions.

With this project, Neurotec is moving towards clinical proof of concept for the first molecule to come out of their own research and Advancell is reaffirming its business model based on developing new drugs through Phase II. Once the trial has been successfully completed, both companies plan to license the drug to a pharmaceutical company, which will continue its development and bring it to market.

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