PR Newswire
06/20/05, 8:30a
(Copyright © 2005, PR Newswire)

LOS ANGELES, June 20, 2005 /PRNewswire-FirstCall via COMTEX/ -- CytRx Corporation, a biopharmaceutical company engaged in the development and commercialization of human therapeutics primarily in the area of small molecules and ribonucleic acid interference (RNAi), today announced it has submitted a reply to a request for additional information from the U.S. Food and Drug Administration (FDA) related to the Company's investigational new drug (IND) application for arimoclomol for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). CytRx announced filing of the IND on May 23, 2005 and submitted the additional documents requested by the FDA last Friday. Receipt by the FDA of the Company's response will trigger a 30-day waiting period prior to trial initiation. Pending a favorable review of CytRx's response by the FDA, CytRx expects to begin this landmark Phase II trial promptly.

"It is common for the FDA to seek additional information regarding testing of a novel compound such as arimoclomol prior to the start of the clinical program," said Steven A. Kriegsman, President and CEO of CytRx. "Based on our successful meeting with our clinical trial principal investigators last week, we should be ready to begin the Phase II trial once a favorable review from the FDA is received."

Jack Barber, Ph.D., Senior Vice President of Drug Development, added, "Since filing the IND, we have not heard anything from the FDA that makes us any less confident of our ability to enter into a Phase II trial for arimoclomol, and our preparations for the trial continue unabated. We have assembled a team of renowned neurologists throughout the United States to conduct the planned trial, with Dr. Robert Brown, Jr. acting as principal investigator."

Dr. Brown is the founder and director of the Cecil B. Day Laboratory for Neuromuscular Research at Massachusetts General Hospital, professor of neurology at Harvard Medical School and a noted ALS authority. In 1993 he was among the scientists who discovered that a mutation in the SOD1 gene causes the familial, or inherited, form of ALS.

About Arimoclomol and ALS

Arimoclomol is believed to function by a mechanism that stimulates a normal cellular protein repair pathway through the activation of "molecular chaperones." Since damaged proteins called aggregates are thought to play a role in many diseases, CytRx believes that activation of molecular chaperones with its drug candidates could show therapeutic efficacy over a broad range of diseases, including ALS. Last month CytRx announced that the FDA granted arimoclomol orphan drug status designation for the treatment of ALS