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news.CytRx has said that its drug arimoclomol has been granted orphan medicinal product status for the treatment of ALS known as amyotrophic lateral sclerosis, by the European Commission.
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This orphan medicinal product status grants CytRx market exclusivity in the European Union for 10 years in the event that arimoclomol receives marketing approval. The status provides for incentives such as reduced fees for protocol assistance and scientific advice.
“We appreciate the European Commission’s recognition of arimoclomol as a potential drug for ALS,” said CytRx president and CEO 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 European Commission grants orphan medicinal product status to promote the innovation of drugs that are developed to treat, prevent or diagnose diseases or conditions that affect no more than five in 10,000 persons in the EU.
Arimoclomol received orphan drug status from the FDA for the treatment of ALS in May 2005.
CytRx plans to initiate a phase IIb trial in the US and Canada in mid-2007. The company believes that positive efficacy and safety results from the phase IIb trial could be sufficient for arimoclomol product registration in the US for this indication.