AMA Morning Rounds: FDA lifts clinical hold on CytRx Lou Gehrig's treatment

The AP (12/2) reported that the FDA "lifted a nearly two-year suspension on development of" CytRx Corp.'s "arimoclomol as a treatment for Lou Gehrig's disease." The agency "halted arimoclomol studies" in January 2008, "citing the need for additional analysis from previously completed animal studies with arimoclomol."

Reuters (12/2) reported that the FDA accepted CytRx's revised trial protocol to review the safety and efficacy of the experimental drug at four times the dose previously studied. The FDA has granted the drug a fast-track review and orphan drug status to treat Lou Gehrig's disease.