CYTRX'S ALS DRUG GRANTED EUROPEAN ORPHAN DRUG STATUS

CytRx's lead drug candidate, arimoclomol, has been granted orphan medicinal product status for the treatment of amyotrophic lateral sclerosis (ALS) by the European Commission. This status gives CytRx market exclusivity in the European Union for 10 years upon marketing approval and provides for incentives such as reduced fees for protocol assistance and scientific advice.

The drug received orphan drug status from the FDA for the treatment of ALS in 2005. Orphan drug status in the U.S. also holds numerous potential benefits, including opportunities for grant funding toward clinical trial costs, tax advantages, FDA user fee benefits, seven years of U.S. market exclusivity upon approval for the drug and an added mechanism for more frequent communication with the FDA.

Based on the company's September announcement of meeting the primary safety and tolerability endpoints in a Phase IIa trial with arimoclomol as an ALS treatment, CytRx plans to initiate a Phase IIb trial in the U.S. and Canada in mid-2007. The company believes that positive efficacy and safety results from the Phase IIb clinical trial could be sufficient for arimoclomol product registration in the U.S. for this indication.

This small-molecule drug candidate is believed to function by stimulating a normal cellular protein repair pathway through the activation of molecular chaperones. Since damaged proteins called aggregates are thought to play a role in many diseases, CytRx believes that activation of molecular chaperones could have therapeutic efficacy for a broad range of diseases.