Home » CYTRX RECEIVES CORRESPONDENCE FROM FDA ABOUT ALS STUDY
CYTRX RECEIVES CORRESPONDENCE FROM FDA ABOUT ALS STUDY
August 10, 2005
CytRx reported that the FDA has provided a written explanation of the reasons for the clinical hold placed on the company's Phase II trial for its oral drug candidate arimoclomol for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease).
In a recent email, the FDA cited two actions required to be taken by CytRx in order to lift the clinical hold: 1) submission by CytRx of existing clinical information on its related small molecule drug candidate bimoclomol, which has been more extensively tested for safety in humans than arimoclomol.; and 2) amendment by CytRx of the protocol for the clinical trial to add specific clinical tests to be administered to patients enrolled in the study.
KEYWORDS Drug Pipeline Alert
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