Before the opening bell, International Stem Cell Corp. (OTCQB: ISCO) announced that the first patient in its ongoing phase I clinical trial of human parthenogenetic neural stem cells (ISC-hpNSC) for the treatment of moderate to severe Parkinson’s disease has undergone a successful intracranial transplant of ISC-hpNSC at the Royal Melbourne Hospital in Australia. This milestone marks a major step toward the completion of the dose escalation safety and preliminary efficacy study, which will evaluate three different dose regimens of ISC-hpNSC in a total of 12 participants over the coming months.
“This is a major step forward in our search for a cure for Parkinson’s Disease,” Russell Kern, PhD, executive vice president and chief scientific officer of ISCO, stated in this morning’s news release. “We are thrilled to initiate this clinical trial and prove that neural stem cells can be a part of the solution. We are hopeful that ISC-hpNSC will prove to be a valuable therapy.”
In recent months, ISCO has remained focused on the start of this clinical trial. The company initially commenced enrollment in March of this year before securing $6.3 million through a private placement in order to adequately fund the study. In June, ISCO officially concluded the preclinical stage of its Parkinson’s disease program when it announced the publication of the results of a 12-month preclinical, non-human primate study demonstrating the safety and efficacy of its ISC-hpNSC for the treatment of Parkinson’s disease.
“We believe that stem cells are part of the solution to finding a cure for Parkinson’s Disease,” Andrey Semechkin, PhD, co-chairman and CEO of ISCO, stated in the news release. “There is real potential for millions of people who currently suffer from Parkinson’s Disease to truly benefit from using ISC-hpNSC.”
Parkinson’s disease is a degenerative disorder of the central nervous system that affects an estimated seven to 10 million people worldwide, according to the Parkinson’s Disease Foundation, making it the second most common neurodegenerative disease in the world. While no cure exists, currently-available treatments for this debilitating disease, including L-DOPA and dopamine agonists, are moderately effective toward improving the early symptoms of Parkinson’s. However, as dopaminergic neurons are lost to the progression of the disorder, these drugs become ineffective and often produce a complication marked by involuntary writhing movements.
In preclinical studies in rodents and non-human primates, ISCO’s ISC-hpNSC have been effective in improving Parkinson’s symptoms and increasing brain dopamine levels while offering neurotrophic support and cell replacement to the dying dopaminergic neurons of the recipient’s brain. Moving forward, ISCO will continue to oversee the ISC-hpNSC clinical study through subsidiary Cyto Therapeutics Pty Ltd. In a prior news release, the company set a tentative date of Q4 2016 for the release of preliminary clinical data.
For more information, visit www.internationalstemcell.com
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