FDA Hold Lifted, CytRx to Resume ALS Trials With New Protocol

CytRx may resume clinical trials of its oral drug arimoclomol to treat amyotrophic lateral sclerosis (ALS) because the FDA has accepted its revision of a study protocol. The new protocol calls for a Phase II ascending-dose study of the drug candidate, which allows a safety assessment and a preliminary efficacy evaluation in treated patients with ALS, or Lou Gehrig’s disease, the Los Angeles-based company says. The company predicts data will be available 18 months after the trial starts.
Clinical Trials Advisor