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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