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news.Los Angeles-based CytRx Corporation has reported the FDA's decision to place a hold on the clinical testing of arimoclomol, CytRx's drug candidate for the treatment of amyotrophic lateral sclerosis, pending the supply of additional data on the drug.
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The FDA request is in response to an investigational new drug application (IND) filed by the company in May 2005.
“We appreciate the FDA’s consideration in carefully reviewing our IND and intend to work diligently with them to address any questions that they may have so that this important study can proceed,” said Steven Kriegsman, President and CEO of CytRx. “We are committed to advancing our clinical studies in Lou Gehrig’s disease, for which there currently is no effective therapeutic treatment.”
The phase II trial is designed to investigate the safety and tolerability of arimoclomol in ALS patients. Arimoclomol, which was well absorbed and well tolerated in two phase I clinical trials in healthy volunteers, and was granted orphan drug status designation by the FDA for the treatment of ALS in May 2005.
CytRx has said that it expects to be in “active dialogue” with the FDA to address any outstanding matters.
Amyotrophic lateral sclerosis (ALS) is a progressive degeneration of the brain and spinal column nerve cells that control the muscles that allow movement.