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The companies Advancell, Neurotec Pharma and Aromics have created an economic interest group (EIG), called MSALS, to develop a new treatment for multiple sclerosis, a disease that currently affects 2.5 million people worldwide (30,000 in Spain). The clinical portion of MSALS will be coordinated by Hospital Clínic de Barcelona, Hospital Vall d'Hebron and University of Barcelona-IDIBAPS.    

"This project is a prime example of how scientific results generated in university labs can be successfully transferred to the business world", said the CEO of Neurotec Pharma, Marco Pugliese.

The three biotech companies, located at the Barcelona Science Park (PCB), are also receiving funding from the Catalan government agency ACC1Ó, through the program Nuclis d’Innovació Tecnològica.

Multiple sclerosis (MS) is a chronic inflammatory and degenerative disease that is diagnosed principally in women aged 20 to 50 years. Its clinical hallmark is severe damage to the central nervous system: it can eventually cause loss of sensitivity, loss of balance, difficulty in speech, blurred vision or blindness, fatigue, and muscle stiffness or paralysis, among other symptoms. Multiple sclerosis is now the second leading cause of permanent disability after traffic accidents.    

The drugs presently used to treat MS, which are immunomodulators, have limited efficacy and numerous side effects and must be administered intravenously or injected.

The new drug proposed by the Catalan companies, NT-KO-003, has demonstrated anti-inflammatory and neuroprotective effects in animal models. Moreover, unlike the current treatments for MS, it can be administered orally and could be combined with other drugs, if needed, without any consequent increase in toxicity, enabling treatment of nearly all MS patients.  The drug would be the first to both slow the development of the disease and reduce the neurological damage that it causes. Lastly, NT-KO-003 may also offer hope as a treatment for other neuromuscular diseases such as amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s disease).

Clinical trials in 2011

The clinical trials of NT-KO-003 in will begin in the first quarter of 2011, in a cohort of 100 MS patients at ten hospitals in Spain and three hospitals in Germany.

The drug is Neurotec’s first in-house molecule to reach clinical trials. The NT-KO-003 program has given Aromics a chance to validate new biomarkers for MS. According to the CEO of Aromics, Carme Plasencia, this program exemplifies the company’s “activity in the area of personalized medicine, promoting a combination of improved diagnosis with a safer, more effective therapy to help patients". For Advancell the program confirms the company’s business model of developing a drug to proof-of-concept (Phase II clinical trials). "This project demonstrates our commitment to creating value and to responding to unmet medical needs", said Davide Sirtoli, president of Advancell.

The total cost of developing NT-KO-003 is roughly €4 million, whereas the potential market for the drug is estimated at roughly €5.3 billion.

If the clinical trials are completed successfully, then Advancell and Neurotec Pharma will license the drug to a pharmaceutical company that would then take over its development to bring it to market.

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