Today, Neuralstem, developers of a revolutionary platform of patented technologies for the production of neural stem cell lines and cell therapies, reported dosing of the fourteenth patient in its ongoing Phase I clinical trialing of the company’s spinal cord neural stem cells in ALS (amyotrophic lateral sclerosis or Lou Gehrig’s disease), marking the second patient to receive cells in the cervical (upper back) region of the spine and the trial’s first female patient. This is the first FDA-approved neural stem cell trial for the treatment of ALS.
This treatment is designed to help remediate breathing function loss associated with progressive ALS, and the transplantation of stem cells observed in the trial will be keenly watched for safety/efficacy of spinal cord neural stem cells, as well as the intraspinal transplantation method. The first twelve patients received lumbar (lower back) transplants and the trial has now been underway since January of 2010.
Having begun with non-ambulatory patients and progressing to patients able to walk, this trial has now entered into the final six patients, all of whom will receive cervical transplants, with trial conclusion projected for six months after the final surgery is complete. The proprietary CUR spinal cord delivery platform with floating cannula has helped tremendously in making this dream a possibility and represents a true breakthrough in the field, making the first ever intraspinal injections feasible.
Chairman and CSO of CUR, Karl Johe, PhD., was proud to be breaking new ground with this latest cohort of patients, as it represents a major milestone for the trial, with direct implantation of cells into the “gray matter of the spinal cord in the cervical region.” Dr. Johe was especially proud of the potential these successful surgeries represent for the numerous patients who suffer from significant quality of life impairment due to ALS. With the 14th successful transplant notched into their belts, CUR is confident that the demonstration of safety in this novel procedure is going quite well.
This is a huge coup for CUR which is also making significant advancements towards developing a robust cell therapy platform capable of addressing a wide range of major central nervous system conditions, ranging from spinal cord injuries and chronic stroke, to ischemic spastic paraplegia and other crippling conditions. The company has an IND submitted to FDA for Phase I safety trials in chronic spinal cord injury.
The company is also well-positioned to service systematic screening needs in the large chemical library space. With proprietary screening technology and the ability to generate appropriate human neural stem cell lines, CUR is ready to leverage discovered/patented compounds that help to stimulate brain activity and neuron regeneration. The potential exists to even reverse debilitating CNS conditions.
The company has also received FDA clearance to conduct a Phase Ib safety trial for their first small molecule compound, NSI-189, for treatment of MDD (major depressive disorder); technology that could easily pan out into schizophrenia, bipolar disorder, and Alzheimer’s offerings.
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