CytRx reports successful completion of sclerosis safety trial

The main objective of the study was to assess the efficacy and safety of the drug. No significant adverse effects were reported. Additionally no treatment-related effects on vital signs, electrocardiogram or body weight were observed.

One of the endpoints of the trial included an analysis of drug absorption and removal. While full analysis of these data is not yet complete, tests indicate that arimoclomol effectively entered the cerebral spinal fluid. This demonstrated that the drug passed the blood-brain barrier, overcoming a potential impediment for the development of drugs like arimoclomol that are intended to treat neurodegenerative diseases.

The trial also monitored disease progression as a secondary aim. Arimoclomol did not show a statistically significant change in disease progression as measured by these markers. However, CytRx commented that this was due to the limited size and duration of the trial and the average decrease in progression was higher in the placebo group in some cases.

Based on these results, CytRx plans to proceed with initiating a phase IIb clinical trial with arimoclomol for the treatment of ALS in the first half of 2007, subject to FDA approval.

“We believe that positive efficacy and safety results from the Phase IIb clinical trial could be sufficient for arimoclomol product registration for this indication,” commented Steven Kreigsman, CEO of CytRx.