ROCKVILLE, Md., Dec. 18 Neuralstem, Inc.(NYSE Alternext US: CUR) announced this morning that it has filed anInvestigational New Drug (IND) application with the U.S. Food and DrugAdministration (FDA) to begin a clinical trial to treat amyotrophic lateralsclerosis (ALS or Lou Gehrig's disease). The Company is planning to treat ALSpatients through spinal injections of its stem cells via its patented HumanNeural Stem Cell technology.
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"Like all first human trials, this proposed trial is primarily designed totest the safety and feasibility of both our stem cells and our method ofdelivering the cells to the spinal cord in ALS patients," said Neuralstem CEOand President, Richard Garr. "We are also proposing secondary endpoints whichwe hope will be able to measure a slowing down of the degenerative process."
ALS is a progressive neurodegenerative disease that affects nerve cells inthe brain, leading to the degeneration and death of the motor neurons in thespinal cord that control the muscles. Loss of the ability to initiate andcontrol muscle movement ends in paralysis and, ultimately, death. ALS affectsroughly 30,000 people in the U.S., with about 7,000 new diagnoses per year.
Neuralstem expects to conduct the trial at Emory University with Dr.Johnathan Glass, M.D., Director of the Emory Neuromuscular Laboratory andDirector of the Emory ALS Center, as site Principal Investigator (PI). Dr. EvaFeldman, M.D., Ph.D., Head of the A. Alfred Taubman Medical Research Instituteand the De Jong Professor of Neurology at the University of Michigan MedicalSchool, will be the overall PI for the ALS trial program. Formal approvalsfrom these institutions to conduct the trial can come only after FDA approvalof the trial protocol.
"The filing of this IND is an important event for Neuralstem," said Garr,"but it marks only the beginning of a process which includes working togetherwith the FDA to approve the first human ALS stem cell trial; refining ourunderstanding of how to optimize delivery of our cells into patients; andultimately delivering a new treatment for patients with this currentlyincurable disease."
Neuralstem's patented technology enables, for the first time, the abilityto produce neural stem cells of the human brain and spinal cord in commercialquantities, and the ability to control the differentiation of these cells intomature, physiologically relevant human neurons and glia. Major Central NervousSystem diseases targeted by the Company with research programs currentlyunderway include: Ischemic Spastic Paraplegia, Traumatic Spinal Cord Injury,Huntington's disease and ALS. The Company filed an IND (Investigational NewDrug) application with the FDA for ALS clinical trials in December, 2008, andhas entered into a collaborative agreement with Albert-Ludwigs-University, inFreiburg, Germany, to develop clinical trials for Huntington's disease.
In pre-clinical work, the company's cells have extended the life of ratswith ALS (Lou Gehrig's disease) as reported the journal TRANSPLANTATION, incollaboration with Johns Hopkins University researchers, and also reversedparalysis in rats with Ischemic Spastic Paraplegia, as reported inNEUROSCIENCE on June 29, 2007, in collaboration with researchers at Universityof California San Diego.
Cautionary Statement Regarding Forward Looking Information
This news release may contain forward-looking statements made pursuant tothe "safe harbor" provisions of the Private Securities Litigation Reform Actof 1995. Investors are cautioned that such forward-looking statements in thispress release regarding potential applications of Neuralstem's technologiesconstitute forward-looking statements that involve risks and uncertainties,including, without limitation, risks inherent in the development andcommercialization of potential products, uncertainty of clinical trial resultsor regulatory approvals or clearances, need for future capital, dependenceupon collaborators and maintenance of our intellectual property rights. Actualresults may differ materially from the results anticipated in theseforward- looking statements. Additional information on potential factors thatcould affect our results and other risks and uncertainties are detailed fromtime to time in Neuralstem's periodic reports, including the annual report onForm 10-KSB for the year ended December 31, 2007 and the quarterly report onform 10-Q for the period ended September 30, 2008.
SOURCE Neuralstem, Inc.