Avicena To Proceed Phase III Amyotrophic Lateral Sclerosis Trial
Phase III Amyotrophic Lateral Sclerosis Trial
Avicena Group and FDA will proceed with a confirmatory Phase III trial for treatment of amyotrophic lateral sclerosis (ALS, or Lou Gehrig's disease).
Two completed Phase III studies led by Dr. Jeffrey Rosenfeld of the Carolinas ALS Center and North East ALS Consortium (NEALS) demonstrated a positive trend towards increased survival at 9 months. The results of the studies are pending publication. Further, Avicena will be analyzing the data at the 18-month time point to confirm a longer term survival benefit.
These data will be used to support a new Phase III study which is planned to commence in 2008. The new Phase III study will be designed to evaluate AL-02's potential to increase survival.
"We are very pleased with the FDA's feedback and we eagerly anticipate moving AL-02 forward into a confirmatory Phase III trial during the first quarter of next year," stated Belinda Tsao-Nivaggioli, Chief Executive Officer of Avicena. "Given the severity of this unmet medical need, the advancement of our lead ALS drug candidate represents significant progress for Avicena and our collaborators, NEALS and the Carolinas ALS Center. 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."
ALS is a neurodegenerative disease that attacks the motor neurons of the brain and spinal cord that are responsible for voluntary muscle movement. As these motor neurons degenerate, their ability to send impulses to the muscle fibers is compromised. The progressive degeneration of motor neurons eventually leads to neuron death resulting in the brain's inability to initiate or control muscle movement. Once a patient's muscles no longer receive the messages that they require to function, the muscles begin to atrophy. With an incidence rate of approximately 1 in 10,000, ALS affects roughly 30,000 Americans at any given time. Each year, approximately 5,600 new cases of ALS are diagnosed.