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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