Before the opening bell, International Stem Cell Corporation
(OTCQB: ISCO) took a major step in the development of its human parthenogenetic
stem cell-derived neural stem cells (ISC-hpNSC) for the treatment of moderate
to severe Parkinson’s disease when it announced the commencement of enrollment
for its upcoming phase I clinical trial. This announcement followed the
Melbourne Health Human Research Ethics Committee’s (HREC) recent decision to
grant approval of the phase I clinical trial in patients with moderate to
severe Parkinson’s disease. The trial is scheduled to take place at the Royal
Melbourne Hospital in Australia.
“Enrollment in this trial is an important milestone,” Dr.
Russell Kern, executive vice president and chief scientific officer of ISCO, stated
in this morning’s release. “Promising preclinical results support our
expectation that ISC-hpNSC will bring a long-needed solution for patients
suffering from Parkinson’s disease.”
Following completion of enrollment, ISCO will commence a
dose escalation safety and preliminary efficacy study of its proprietary
ISC-hpNSC. The clinical trial will involve intracranial transplantation of the
stem cells into patients with moderate to severe Parkinson’s disease. A total
of 12 patients are expected to participate in the trial, with three different
dose regimens being studied. Following transplantation, the patients will be
monitored at specified intervals for one year, with PET scans being performed
as part of the screening assessment. The study’s submission will be overseen by
Cyto Therapeutics Pty Ltd., a subsidiary of ISCO.
ISC-hpNSC have demonstrated promising results in preclinical
studies. In both rodents and non-human primates, the highly pure stem cells
have supported improvement in Parkinson’s symptoms and increases in brain
dopamine levels. Additionally, ISC-hpNSC have been safe, well-tolerated and
free from adverse side effects such as dyskinesia, systemic toxicity and tumors
in preclinical models.
If approved, ISCO’s groundbreaking approach to the treatment
of Parkinson’s disease could revolutionize an expansive treatment market.
Currently, medications used to treat Parkinson’s, including L-DOPA and dopamine
agonists, serve only to improve the early symptoms associated with the disease.
As the illness progresses, the loss of dopaminergic neurons eventually renders
these drugs ineffective while at the same time producing a complication marked
by involuntary writhing movements. In recent years, incidence of Parkinson’s
has been on the rise. In 2013, the disease resulted in roughly 103,000 deaths
globally, up from about 44,000 deaths in 1990.
For more information, visit www.internationalstemcell.com
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