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ALS/MND Drug Trials

Avicena announced that patient enrollment for the first stage of its Phase II ALS clinical trial has been completed by the trial's lead investigator, Paul H. Gordon, M.D., of the Eleanor and Lou Gehrig MDA/ALS Research Center at Columbia University in New York.

When Elizabeth Lee Hallam was born on Sept. 29, 2003, she was a textbook example of the perfect baby. But by 8 months of age, she was battling a fatal genetic disease her family had never heard of (spinal muscular atrophy). Despite the grave circumstances of her disease, Elizabeth is doing tremendoulsly well under a new therapy.

Researchers at the San Francisco VA Medical Center have identified the mechanism by which minocycline, a medication currently being studied for the treatment of neurodegenerative diseases including Parkinson's disease and Huntington's disease, protects brain and nerve cells from damage.

Avicena said its potential drug for Lou Gehrig's disease (ALS-02) failed in trials to improve muscle strength and function. The drug did show a trend of reduced mortality. Further study will be needed with the hopes for eventual FDA approval should continued studies show treatment success.

CytRx has completed its enrollment in Phase IIa clinical trial for ALS; the data from this trial is expected to be released in the third quarter of 2006.

"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," said Steven Kriegsman (CEO) of CytRx.

Phase II clinical trial of a molecule drug candidate arimoclomol for the treatment of amyotrophic lateral sclerosis.

Scientists at Mount Sinai School of Medicine have identified the first biomarkers for amyotrophic lateral sclerosis (ALS). These findings pave the way for a reliable test that will identify ALS sufferers at an earlier stage of the disease, and give more chances to companies developing disease-modifying drugs.

The primary aim of the drug trial is to determine whether treatment with thalidomide is safe and well tolerated in conjunction with riluzole and whether patients with ALS can tolerate daily doses of up to 400 mg.