FDAnews
www.fdanews.com/articles/84521-cytrx-initiates-als-open-label-extension-trial

CYTRX INITIATES ALS OPEN-LABEL EXTENSION TRIAL

February 13, 2006

CytRx has enrolled the first patient in an open-label extension clinical trial with its lead small-molecule product candidate arimoclomol for the treatment of amyotrophic lateral sclerosis (ALS, or Lou Gehrig's disease).

The company also announced that it is on track to complete enrollment this quarter in its 80-patient, multicenter, double-blind, placebo-controlled Phase IIa clinical trial with arimoclomol for the treatment of ALS. To date, of the 80 patients who have been screened for participation, 59 have tarted the treatment regimen. Patients receive either placebo (a capsule without drug) or one of three dose levels of arimoclomol capsules three times daily for a period of 12 weeks. The primary endpoints for this trial are safety and tolerability.