( trialdesign to maximize our chances of...)CytRx Announces Clinical Results from Its Rising Multiple Dose,Trial with Arimoclomol for ALS,Health

The double-blind, placebo-controlled rising multiple dose study, which was announced in February 2007, was designed to identify the highest safe and well-tolerated arimoclomol dose. Forty healthy volunteers were divided evenly into groups of 10 subjects. In each group three subjects received a placebo capsule without drug and seven received arimoclomol at either 100 mg (the highest dose provided in the Phase IIa double-blind and open-label extension studies), 200 mg, 400 mg, or 600 mg three times daily over a seven day period. Dose escalation proceeded carefully, with safety and tolerability demonstrated at lower dose levels prior to testing higher doses. The study indicated that all four doses were safe and well-tolerated. Based on these results and additional data, CytRx plans to proceed with a 400 mg dose of arimoclomol three times daily in its planned Phase IIb efficacy trial.

"While these results indicate that we could potentially use an even higher dose of arimoclomol, we selected 400 mg for our upcoming efficacy trial for several reasons," said Jack Barber, Ph.D., CytRx's Chief Scientific Officer. "First, the 400 mg dose resulted in drug serum exposures higher than those that have provided maximum therapeutic benefit in animals. Second, using less than the highest possible dose potentially provides a margin of safety for ALS patients. Finally, larger doses may not be practical in this population as the capsules could be too large for ALS patients who sometimes have difficulty swallowing."

CytRx is presently conducting a follow-up clinical trial in healthy volunteers to provide longer-term safety and tolerability information at the 400 mg dose. This double-blind, placebo-controlled study includes 16 healthy volunteers: four are receiving a placebo capsule without drug and 12 are receivi
'"/>