Neuralstem Receives FDA Approval to Commence First ALS Stem Cell Trial

Mon, 09/21/2009 - 4:39am
Neuralstem, Inc. today announced that the FDAhas approved its Investigational New Drug (IND) application to commence aPhase I trial to treat Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig'sdisease) with its spinal cord stem cells. Neuralstem is the first company to commence a stem cell trial to treatALS. The trial will study the safety of Neuralstem's cells and the surgicalprocedures and devices required for multiple injections of Neuralstem's cellsdirectly into the grey matter of the spinal cord. The FDA's approvalrepresents a significant step toward delivering regenerative medicine directlyto damaged neural cells in humans. ALS affects roughly 30,000 people in theU.S., with about 7,000 new diagnoses per year. Neuralstem CEO and President, Richard Garr, stated, "The beginning of ourclinical trial program is a major step towards achieving Neuralstem's goal oftreating ALS, a fatal neurodegenerative disease for which currently there isno effective treatment or cure. While this trial aims to primarily establishsafety and feasibility data in treating ALS patients, we also hope to be ableto measure a slowing down of the ALS degenerative process. This trial will bein the extremely capable hands of Dr. Eva L. Feldman, M.D., Ph.D., Director ofthe University of Michigan Health System ALS Clinic and the Program forNeurology Research & Discovery, and Dr. Jonathan Glass, Director of the EmoryNeuromuscular Laboratory and Director of the Emory ALS Center, world-renownedfor their study and treatment of ALS patients. We believe that there is nobetter team to conduct this study for us," said Garr. Their participation issubject to formal IRB approval by their institutions. "We are very excited about this clinical trial," said Dr. Eva L. Feldman,who will direct the Neuralstem clinical trial program for ALS. "This is amajor advancement in what still could be a long road to a new and improvedtreatment for ALS. ALS is a terrible disease that ultimately kills byparalysis," said Feldman, who also directs the A. Alfred Taubman MedicalResearch Institute. "In work with animals, these spinal cord stem cells bothprotected at-risk motor neurons and made connections to the neuronscontrolling muscles. We don't want to raise expectations unduly, but webelieve these stem cells could produce similar results in patients with ALS,"Dr. Feldman concluded.

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