Monday, October 24, 2011

Neuralstem Receives FDA Approval to Dose Patients in Cervical Region in Ongoing ALS Trial

Source: Neuralstem, Inc.
Date: October 24, 2011

Summary:

ROCKVILLE, Md. -- Neuralstem, Inc. updated the progress of its ongoing Phase I safety trial of the company's spinal cord stem cells in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) at Emory University in Atlanta, Georgia. The company announced that, after reviewing safety data from the first 12 patients, the Food and Drug Administration (FDA) has granted approval for the trial to advance to transplanting patients in the cervical (upper back) region. Until now, patients have received injections in the lumbar (lower back) region only. Earlier this summer, the trial's Safety Monitoring Board unanimously approved moving to the cervical injection phase. The trial will now advance to the final two cohorts of patients with ALS, all of whom will be transplanted in the cervical region of the spine.