Drug Development

FDA grants fast track designation for arimoclomol in ALS

Published in Medical Letter on the CDC and FDA, November 6th, 2005

CytRx Corp. (CYTR), a biopharmaceutical company engaged in the development and commercialization of human therapeutics primarily in the area of small molecules and ribonucleic acid interference, announced that the U.S. Food & Drug Administration (FDA) has granted fast track designation for the company's leading drug candidate arimoclomol for the treatment of amyotrophic lateral sclerosis (ALS).

Recently, CytRx announced the initiation of a phase II clinical trial with orally administered arimoclomol for ALS, and patient identification for this trial is underway at several clinical trial sites. Arimoclomol was granted orphan drug status designation by the FDA for the...

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Source: Medical Letter on the CDC and FDA (2005-11-06)

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