CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company engaged in the development of high-value human therapeutics, today announced its intention during the 2009 fourth quarter to submit a revised protocol for its planned Phase IIb clinical trial for arimoclomol as a treatment for amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). The decision follows receipt of an anticipated written letter from the U.S. Food and Drug Administration (FDA) regarding the arimoclomol Phase IIb clinical trial. Under its guidelines, the FDA will have 30 days following CytRx’s planned protocol submission to respond. CytRx expects that the revised protocol will result in the lifting of the clinical hold in the fourth quarter of this year.
“We are delighted with the FDA’s letter, which we believe opens a viable pathway for continued development of arimoclomol for ALS and represents a significant step in its advancement as a potential treatment for this debilitating disease,” said CytRx’s President and CEO Steven A. Kriegsman. “We are addressing the FDA’s letter by formulating a Phase IIb clinical trial protocol that will, among other modifications, include escalating dosing of orally administered arimoclomol up to the 400 milligrams, three times daily as originally planned in the previous protocol. As expected, the FDA letter did not indicate a need for additional animal toxicology studies or other studies prior to the revised protocol submission.