Avicena plans confirmatory ALS trial

Published: July 17, 2007 at 2:27 PM

PALO ALTO, Calif., July 17 (UPI) -- U.S. firm Avicena said Tuesday it would launch a confirmatory phase 3 trial of AL-02 to treat amyotrophic lateral sclerosis, or Lou Gehrig's disease.

The company said a pair of phase 3 studies already completed suggested the new treatment improves survival in ALS patients at nine months, with data at 18 months yet to be evaluated.

The confirmatory phase 3 trial is set to begin in the first quarter of 2008, Avicena said.

"We hope to duplicate the pooled results of two prior studies which demonstrated AL-02's potential to increase survival of patients afflicted with ALS," said Belinda Tsao-Nivaggioli, Avicena's chief executive officer.

ALS is a neurodegenerative disorder marked by the breakdown of the motor neurons in the brain and spinal cord that control voluntary muscle movement, which interferes with the neurons' ability to send impulses to the muscles. About 30,000 Americans have ALS, with roughly 5,600 new cases diagnosed each year, the company said.

http://www.upi.com/Health_Business/B...ls_trial/2774/