CytRx completes enrollment in phase 2a clinical trial for Lou Gehrig's disease

By Lisa Kerner

Erie, Pa., April 4 - CytRx Corp. said it completed enrolling 84 patients in the first clinical trial with its lead small molecule product candidate arimoclomol for the treatment for amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease), a progressive degeneration of the brain and spinal column nerve cells.

CytRx expects to report final data from this phase 2a trial in the third quarter of this year, followed by initiation of a phase 2b efficacy trial, subject to Food and Drug Administration approval.

The multicenter, double-blind, placebo-controlled trial is being conducted at 10 U.S. centers. Patients receive either a placebo or one of three dose levels of arimoclomol capsules three times daily for 12 weeks.

CytRx said the primary endpoints for the phase 2a trial are safety and tolerability.

Secondary endpoints include a preliminary evaluation of efficacy using the revised ALS Functional Rating Scale and Vital Capacity, an assessment of lung capacity.

"We are exceptionally pleased to complete enrollment so rapidly, which we believe indicates favorable interest from the ALS community for arimoclomol as a potential treatment for this life-threatening disease," president and chief executive officer Steven A. Kriegsman said in a company news release.

"We met our corporate milestone to complete enrollment in the first quarter of this year, and even enrolled an additional four patients over the initial target of 80, to ensure that we obtained sufficient data to accurately demonstrate how arimoclomol is absorbed, distributed, and eliminated from these patients."

Patients who complete the phase 2a trial, even if treated with a placebo, will have access to orally administered arimoclomol at the highest dose level three times daily for up to an additional six months, officials said.

The phase 2b efficacy trial is expected to include a minimum of 300 ALS patients recruited from 25 clinical sites and take 18 months to complete after enrollment begins.

According to the ALS Survival Guide, 50% of ALS patients die within 18 months of diagnosis and 80% die within five years.

Los Angeles-based CytRx is a biopharmaceutical research and development company that develops human therapeutics.

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