FDAnews
www.fdanews.com/articles/73485-cytrx-phase-ii-trial-for-als-lou-gehrig-s-disease-to-begin-soon

CYTRX PHASE II TRIAL FOR ALS (LOU GEHRIG'S DISEASE) TO BEGIN SOON

June 20, 2005

CytRx (RNAi) has submitted a reply to a request for additional information from the FDA related to the company's investigational new drug (IND) application for arimoclomol for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease).

CytRx has announced filing of the IND on May 23, 2005, and submitted the additional documents requested by the FDA recently. Receipt by the FDA of the company's response will trigger a 30-day waiting period prior to trial initiation. Pending a favorable review of CytRx's response by the FDA, CytRx expects to begin this landmark Phase II trial promptly.