ALS Study May Restart After Clinical Hold

CytRx may be able to resume a Phase IIb clinical trial of its experimental drug arimoclomol for amyotrophic lateral sclerosis (ALS) after submitting data from a new animal study at the FDA’s request. CytRx held a brief telephone conversation with FDA representatives recently, according to a company statement. The agency probably will send a letter by year’s end outlining what steps the company must take to restart the trial, CytRx says, adding that it is considering a strategic partnership to conduct the renewed study. The trial was placed on clinical hold last year due to an animal toxicology study.
Clinical Trials Advisor