CytRx Corp. (CYTR) announced that the U.S. Food and Drug Administration (FDA) lifted a clinical hold on its molecular chaperone candidate arimoclomol for treating patients suffering from amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease). The agency accepted a revised trial protocol while removing the two-year suspension.

The candidate, in mid-stage studies, was placed on clinical hold by the agency in Jan 2008. The FDA cited the need for additional analysis from previously-completed animal toxicology studies. CytRx expects data from the revised trial protocol to be available within 18 months of the commencement of the trial. The study will evaluate safety and efficacy in arimoclomol- treated patients, at levels up to four times the dose administered in previous studies. The maximum dose of the candidate permissible for testing under the revised protocol is 400 milligrams thrice daily.

As a reminder, the candidate was awarded a Fast Track designation by the FDA in 2005 for the treatment of ALS.  In the same year, arimoclomol got orphan status from the U.S. agency. The European Union granted orphan drug status to the candidate in 2006.

The tiered, placebo-controlled, double-blind ascending dose three-month study will see arimoclomol being administered in combination with riluzole (Rilutek), the only currently FDA-approved treatment for Lou Gehrig’s disease. Lou Gehrig’s disease affects nerve cells in the brain and spinal cord. Approximately 120,000 people are affected by the disease globally that causes increasing muscle weakness, inability to control movement and problems related to speaking, swallowing and breathing.

CytRx, headquartered in Los Angeles, California, develops and commercializes pharmaceutical related products and services including human therapeutics focused on high-value critical- care therapies. The company competes with players such as Aeolus Pharmaceuticals Inc. (AOLS), Celgene Corp. (CELG) and Sanofi-Aventis (SNY).

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