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 six non-ambulatory patients, the trial’s Safety Monitoring Board has unanimously approved moving to the next group of ALS patients, all of whom will be ambulatory.
“We are pleased with the progress of the trial to date, and look forward to moving directly into more recently-diagnosed patients,” 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 are encouraged by the Board’s approval to advance the trial to patients who have an earlier stage of the disease,” said Neuralstem’s CEO and president, Richard Garr. “While the primary endpoint of the trial is safety, we also hope to see some secondary endpoints showing efficacy. We are grateful to the patients, and their families, for participating in this trial.”
The first six patients treated in the trial were non-ambulatory. Of these, the first three received five injections each, unilaterally, in the lumbar region of the spinal cord. The next three received ten injections each, bilaterally in the lumbar region. All of the remaining patients in the trial will be ambulatory, and therefore represent earlier stages of disease progression. Of the ambulatory group, the first three patients will receive five injections each, unilaterally, in the lumbar region. The next three will receive ten injections each, bilaterally, in the lumbar region. After the required FDA approval, the final six patients in the trial will receive injections in the cervical region, representing both a progression of treatment up the spinal cord, as well as into more recently-diagnosed patients.
About The Trial
The Phase I trial to evaluate the safety of Neuralstem’s spinal cord stem cells in the treatment of ALS, the first FDA-approved ALS stem cell trial, has been underway since January, 2010. The trial will ultimately consist of up to 18 ALS patients, who will be examined at regular intervals post-surgery, with final review of the data to come six months after the last patient is treated. While the trial is primarily evaluating the safety of the cells and procedure, it will also seek some secondary efficacy endpoints including attenuation of motor function loss, maintenance of respiratory capacity, and stabilization of patients along the ALS functional rating scale.