CYTRX'S ALS STUDY SHOWS NO SIGNIFICANT CHANGE IN DISEASE PROGRESSION

CytRx has announced that its lead drug candidate arimoclomol was shown to be safe and well-tolerated at all three doses tested in its Phase IIa clinical trial in patients with amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease).

In the 10-center, double-blind, placebo-controlled Phase IIa trial, ALS patients received placebo or arimoclomol in one of three dose levels (25 mg, 50 mg or 100 mg) three times daily for 12 weeks and then were studied for an additional four weeks without treatment. Eighty-four patients with ALS entered the clinical trial with only seven withdrawing prior to completion of dosing. No statistically significant treatment-related increases in adverse events were reported, and arimoclomol-treated patients reported fewer asthenia (weakness) adverse events than the patients receiving placebo. No treatment-related effects on vital signs, electrocardiogram or body weight were observed. Based on these results, CytRx plans to proceed with activities associated with initiating a Phase IIb clinical trial with arimoclomol for the treatment of ALS in the first half of 2007, subject to FDA approval.

While disease progression was measured as a secondary endpoint, the primary purpose of the trial was to generate sufficient data regarding safety and tolerability to determine whether to proceed with a significantly larger Phase IIb clinical trial designed primarily to detect efficacy. As was expected by CytRx due to the limited size and duration of the trial, arimoclomol did not show a statistically significant change in disease progression as measured by these markers. However, the average decrease in ALSFRS-R score for those patients receiving the highest dose of arimoclomol was higher than the placebo group at all time points except week 12 after dose initiation.