CytRx Preparing Response to FDA Decision
 

CytRx Preparing Response to FDA Decision



LOS ANGELES — Biopharmaceutical company CytRx Corp. said Monday it is preparing to respond to the Food and Drug Administration following the agency's suspension of its midstage clinical trial of experimental drug arimoclomol last month.

The company said it recently received further clarification from FDA confirming that the decision to halt the trial stemmed from the need for additional analysis from previously completed animal studies with arimoclomol, the company's drug for the treatment of Lou Gehrig's disease.

The FDA's decision was not related to data generated from any human studies with the drug, CytRx said.

The company is now analyzing data from a previously completed toxicology study to prepare a response to the FDA. Following discussions with the agency, CytRx said it will assess the need, if any, to conduct additional toxicology studies before resuming the clinical trial.

"As previously stated, we will take the necessary steps to resolve this matter as expeditiously as possible, and we plan to work with the FDA to address their questions," said President and Chief Executive Steven A. Kriegsman in a release.

Lou Gehrig's disease, a progressive condition that affects nerve cells in the brain and spinal cord, currently has no cure or treatment that halts or reverses the condition.

CytRx shares dropped 21 cents, or 9.3 percent, to $2.05 in midday trading. Shares have traded between $1 and $5.49 in the past 12 months.