FDA lifts 2-year hold on CytRx’s arimoclomol trials

The USFDA lifted a nearly two-year suspension on CytRx’s development of arimoclomol, the orally administered molecular chaperone ALS drug candidate. The news followed approval of a revised clinical trial design for the drug candidate. The company says there is “significant interest” from several potential partners for arimoclomol. Said CytRx CEO Steven Kriegsman, “We are delighted with the FDA’s decision to approve a protocol that provides a safe and efficient avenue to ascend arimoclomol dosing to the target dosage level of 400 mg three times daily, which we believe will prove most effective in treating ALS patients.”

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