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http://www.redorbit.com/news/display/?id=714009
CytRx said Tuesday its potential drug arimoclomol for amyotrophic lateral sclerosis (ALS) was granted orphan drug status in Europe.
European drug regulators grant orphan drug status to drugs that treat serious diseases affecting no more than five in 10,000 people in the European Union. The designation would give CytRx 10 years of market exclusivity upon approval.
The drug -- which treats the condition also known as Lou Gehrig's disease -- was granted orphan drug status in the United States in May 2005, a status granted by the Food and Drug Administration for drugs treating diseases affecting fewer than 200,000 people in the United States. CytRx would get seven years' market exclusivity in the United States if approved.
We appreciate the European Commission's recognition of arimoclomol as a potential drug for ALS, said CytRx President and Chief Executive Officer Steven Kriegsman. This is a life-threatening and debilitating condition for which there is currently no effective treatment and we believe that arimoclomol is based on a novel mechanism of action that may hold a key in ALS therapy.
The small-molecule drug is thought to work by stimulating cellular repair of disease-causing damaged protein via the activation of molecular chaperones.
CytRx said it would launch a phase 2b trial of arimoclomol in the United States and Canada in mid-2007, the data from which the company said could support U.S. approval for the ALS indication.
ALS is a progressive disorder affecting the brain, spinal column and nerve cells that control motor function, which gradually causes muscle weakness, inability to control movement and problems with speaking, swallowing and breathing. About half of ALS patients die within 18 months of diagnosis and 80 percent succumb within five years. More than 120,000 people worldwide have the disease.
Story from REDORBIT NEWS:http://www.redorbit.com/news/display/?id=714009
Published: 2006/10/31 12:00:59 CST
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