CytRx arimoclomol clinical hold
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
CytRx hopes to begin a Phase II trial of its amyotrophic lateral sclerosis treatment arimoclomol by the end of 2005 based on communications from FDA regarding the agency's clinical hold on the trial, the Los Angeles firm says Aug. 10. FDA cited two actions required to lift the hold: submission of existing clinical information on CytRx' related small molecule agent bimoclomol, "which has been more extensively tested for safety in humans than arimoclomol"; and a protocol amendment to the study "to add specific clinical tests to be administered to patients enrolled in the study." CytRx announced the hold July 21...