CytRx: FDA Lifts 2-Year Hold on Arimoclomol Tests
From Associated Press (December 2, 2009)
LOS ANGELES--Shares of biopharmaceutical company CytRx Corp. rose in morning trading Wednesday after the Food and Drug Administration lifted a nearly two-year suspension on development of arimoclomol as a treatment for Lou Gehrig’s disease.
The news follows approval of a revised clinical trial design for the drug candidate. Shares climbed 12 cents, or 12 percent, to $1.12. The stock has ranged from 24 cents to $1.72 over the past year.
In January 2008, the FDA halted arimoclomol studies, citing the need for additional analysis from previously completed animal studies with arimoclomol. In June 2008, the company said it would have to conduct more animal toxicology studies on the drug candidate.
Lou Gehrig’s disease is a progressive condition that affects nerve cells in the brain and spinal cord. Also known as amyotrophic lateral sclerosis or ALS, it currently has no cure or treatment that halts or reverses the condition.
CytRx said it has attracted "significant interest" from several potential partners for arimoclomol, which is in midstage development.
Results from the new midstage study could be available 18 months after the study starts.
Posted: December 2009