CytRx has filed a report to the FDA protesting the January 2009 partial hold on a Phase IIb efficacy clinical trial of arimoclomol, a CytRx ALS drug candidate. Arimoclomol is a molecular chaperone regulator, and it has been targeted for ALS drug development based on the finding that molecular chaperones can prevent the misfolding of proteins that can make them toxic to the body. CytRx is strongly protesting the hold and insists that it has cooperated fully with FDA regulations regarding animal toxicity reports. There are no reports of adverse effects in human trials.
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