Approved to dose last cohort of patients
Neuralstem, Inc. (NYSE Amex: CUR) updated the progress of its ongoing Phase I human clinical trial of the company's spinal cord stem cells in the treatment of ALS (amyotrophic lateral sclerosis, or Lou Gehrig's disease) at Emory University in Atlanta, Georgia. The company announced that, after reviewing the safety data from the first nine patients, the trial's Safety Monitoring Board has unanimously approved moving to the last group of ALS patients in this part of the safety trial. These next three patients, all of whom are ambulatory, will each receive ten injections, bilaterally, in the lumbar spinal cord. After this cohort, the FDA will review the trial data to date before approving it to move into the final cohort of patients, who will receive injections in the cervical region of the spinal cord.
"We are delighted that we've advanced to this final cohort of patients in the first part of the safety trial," commented Dr. Eva Feldman, PhD, MD, Principal Investigator of the trial and a consultant to Neuralstem. Dr. Feldman is Director of the A. Alfred Taubman Medical Research Institute and Director of Research of the ALS Clinic at the University of Michigan Health System. "We have been pleased with the smooth progress of the trial thus far, from non-ambulatory to ambulatory patients who have an earlier stage of the disease."
"We are greatly encouraged by the SMB's approval to advance the trial to the final three patients to receive full lumbar injections," said Karl Johe, PhD, Chief Scientific Officer and Chairman of Neuralstem's Board of Directors. "The trial has progressed as expected, and we are deeply indebted to the patients and families who have taken part."