The company was informed that this decision was based on the need for additional analysis from previously completed animal toxicology studies with arimoclomol. Arimoclomol has been shown to be safe and well-tolerated after being administered to approximately 185 study volunteers. CytRx has requested further clarification from the FDA, which is expected in the next several weeks. Based on the limited information provided by the FDA, the company intends to work diligently to respond as promptly as possible following receipt of an anticipated written correspondence from the FDA.
CytRx is continuing preparations to submit investigational new drug applications to the FDA to begin a Phase II clinical trial with arimoclomol in stroke recovery, and a Phase II clinical trial with iroxanadine, a second small-molecule drug candidate, as a treatment for diabetic foot ulcers. The company plans to begin the stroke recovery Phase II clinical trial in the first half of 2008 and to begin the diabetic foot ulcer Phase II clinical trial in the second half of the year, in each case subject to FDA clearance.