Before the opening bell, International Stem Cell Corp. (OTCQB: ISCO) announced the publication of results from a 12-month preclinical, non-human primate study. The data highlights the safety and efficacy of ISCO’s proprietary human parthenogenetic stem cells-derived neural stem cells (ISC-hpNSC®) for the treatment of Parkinson’s disease. According to the results of this study, transplantation of the neural cells was both safe and well tolerated by non-human primates, with the animals demonstrating no serious adverse events throughout the 12-month trial.
“The publication of the data in the peer-reviewed and highly-respected journal, Cell Transplantation, brings to conclusion the preclinical stage of ISCO’s Parkinson’s disease program,” Russell Kern, Ph.D., chief scientific officer of ISCO, stated in this morning’s news release. “The data provides further evidence that parthenogenetic neural stem cells can be effective in treating the symptoms of Parkinson’s disease and, along with the previously [submitted] safety data, formed the basis of our application to the Australian regulatory authorities to move this program into the clinic.”
To view the full article and abstract, visit http://dtn.fm/kB2eZ
Review of data stemming from this preclinical study played a key role in ISCO’s authorization from the Therapeutics Goods Administration of Australia to initiate a phase I/IIa clinical trial of its innovative ISC-hpNSC for the treatment of moderate to severe Parkinson’s disease. In December, the company announced this approval and entered into a master clinical research agreement with the Florey Institute of Neuroscience and Mental Health, one of the world’s leading brain research centers, to conduct the impending dose escalation trial. In March, ISCO commenced enrollment for its phase I trial. Preliminary clinical data stemming from this study is expected in the fourth quarter of this year.
According to the Parkinson’s Disease Foundation, an estimated seven to 10 million people worldwide are currently living with Parkinson’s disease, making it the second most common neurodegenerative disease. Currently without a cure, the combined direct and indirect costs stemming from this debilitating condition, including treatment, social security payments and lost income from inability to work, are estimated at $25 billion per year in the United States alone.
In preclinical studies, ISCO’s ISC-hpNSC have shown effective in improving Parkinson’s disease symptoms by increasing the presence of dopaminergic neurons and bolstering dopamine concentration in the brain through neurotrophic support and dopaminergic neuron replacement. In particular, the cells’ ability to replace and protect dopaminergic neurons while restoring neural function is expected to offer significant potential benefit to patients suffering from moderate to severe Parkinson’s disease.
For more information, visit www.internationalstemcell.com
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