12/2/2009 - CytRx Corp. (NASDAQ:CYTR) announced that the FDA accepted a revised clinical trial protocol for its drug candidate arimoclomol, which is a therapeutic treatment for amyotrophic lateral sclerosis (ALS).

The clinical trial protocol that was accepted is a tiered, placebo-controlled, double-blind ascending dose study that will include 20 to 30 ALS patients over a three-month period.

CytRx Chief Medical Officer Daniel J. Levitt, M.D.m Ph.D., said, "The revised protocol allows for a safety assessment and a preliminary efficacy evaluation in ALS patients treated with arimoclomol at levels up to four times the dose administered in our prior Phase IIa clinical trial and open label extension study. Arimoclomol will be administered in combination with riluzole (Rilutek®), the only currently FDA-approved treatment for ALS, which typically prolongs life by approximately two months. We currently estimate that data from this trial, should all tiers be completed, will be available approximately 18 months from the time the trial starts."

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