International Stem Cell Corporation Reports Progress in Phase I Clinical Trial for Parkinson's Disease
September 07 2017 - 2:31PM
InvestorsHub NewsWire
CARLSBAD, CA -- September 07, 2017 -- InvestorsHub NewsWire
-- International Stem Cell Corporation (OTCQB:ISCO),
a California-based clinical stage biotechnology company developing
stem cell-based therapies and biomedical products, today reported
that two more patients with Parkinson’s disease were successfully
transplanted with ISCO’s proprietary ISC-hpNSC® cells at the Royal
Melbourne Hospital (RMH), in July and August, 2017. These two
patients are part of the second cohort clinical trial being treated
for Parkinson’s disease. They have received a moderate dosage of
ISC-hpNSC® cells using CT- and MRI-guided stereotactic brain
surgery. The operations were successfully performed by the team of
RMH neurosurgeons without complications.
Russell Kern, PhD, executive vice president and chief scientific
officer of ISCO commented: "We are pleased with the clinical trial
progress and preliminary clinical data collected thus far. We are
looking forward to assessing the moderate-dose therapy used in this
second cohort of Parkinson’s disease patients. The results of our
pre-clinical studies with this dosage demonstrated not only safety,
but also higher efficacy than with the lower dose studies."
About the clinical study
The Phase I clinical study is a dose escalation safety and
preliminary efficacy study of ISC-hpNSC®, intracranially
transplanted into patients with moderate to severe Parkinson's
disease. The open-label, single center, uncontrolled clinical trial
will evaluate three different dose regimens of 30,000,000 to
70,000,000 neural cells. A total of 12 participants with moderate
to severe Parkinson's disease will be treated. Following
transplantation, the patients will be monitored for 12 months at
specified intervals, to evaluate the safety and biologic activity
of ISC-hpNSC®. PET scan will be performed at baseline, as part of
the screening assessment, and at 6 and 12 months after surgical
intervention. Clinical responses compared to baseline after the
administration of ISC-hpNSC® will be evaluated using various
neurological assessments such as Unified Parkinson Disease Rating
Scale (UPDRS), Hoehn and Yahr and other rating scales.
About Parkinson's disease
Parkinson's disease (PD) is a degenerative disorder of the central
nervous system mainly affecting the motor system. The motor
symptoms of Parkinson's disease result from the death of
dopamine-generating cells in the substantia nigra, a region of the
midbrain. Early in the course of the disease, the most obvious
symptoms are movement-related; these symptoms include shaking,
rigidity, slowness of movement and difficulty with walking and
gait. Later, thinking and behavioral problems may arise, with
dementia commonly occurring in the advanced stages of the disease,
and depression is the most common psychiatric symptom. Parkinson's
disease is more common in older people, with most cases occurring
after the age of 50.
Currently, medications typically used in the treatment of
Parkinson's, L-DOPA and dopamine agonists, improve the early
symptoms of the disease. As the disease progresses and dopaminergic
neurons continue to be lost, the drugs eventually become
ineffective while at the same time frequently producing a
complication marked by involuntary writhing movements. In 2013 PD
resulted in about 103,000 deaths globally, up from 44,000 deaths in
1990.
About ISC-hpNSC®
International Stem Cell Corporation's proprietary ISC-hpNSC®
consists of a highly pure population of neural stem cells derived
from human parthenogenetic stem cells. ISC-hpNSC® is a suspension
of clinical grade cells manufactured under cGMP conditions that
have undergone stringent quality control measures and are clear of
any microbial and viral contaminants. Preclinical studies in
rodents and non-human primates have shown improvement in
Parkinson's disease symptoms and increase in brain dopamine levels
following the intracranial administration of ISC-hpNSC®. ISC-hpNSC®
provides neurotrophic support and cell replacement to the dying
dopaminergic neurons of the recipient PD brain. Additionally,
ISC-hpNSC® is safe, well tolerated and does not cause adverse
events such as dyskinesia, systemic toxicity or tumors in
preclinical models. International Stem Cell Corporation believes
that ISC-hpNSC® may have broad therapeutic applications for many
neurological diseases affecting the brain, the spinal cord and the
eye.
About International Stem Cell Corporation
International Stem Cell Corporation (ISCO)
is focused on the therapeutic applications of human parthenogenetic
stem cells (hpSCs) and the development and commercialization of
cell-based research and cosmetic products. ISCO's core technology,
parthenogenesis, results in the creation of human pluripotent stem
cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues
associated with the use or destruction of viable human embryos.
ISCO scientists have created the first parthenogenetic, homozygous
stem cell line that can be a source of therapeutic cells for
millions of individuals of differing genders, ages and racial
background with minimal immune rejection after transplantation.
hpSCs offer the potential to create the first true stem cell bank,
UniStemCell™. ISCO also produces and markets specialized cells and
growth media for therapeutic research worldwide through its
subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and
stem cell-based skin care products through its subsidiary Lifeline
Skin Care (www.lifelineskincare.com). More information is available
at www.internationalstemcell.com.
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and timing of clinical studies, progress of research and
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and its subsidiaries, along with other statements about the future
expectations, beliefs, goals, plans, or prospects expressed by
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that are not historical fact (including, but not limited to
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competing uses, and maintenance of intellectual property rights.
Actual results may differ materially from the results anticipated
in these forward-looking statements and as such should be evaluated
together with the many uncertainties that affect the company's
business, particularly those mentioned in the cautionary statements
found in the company's Securities and Exchange Commission filings.
The company disclaims any intent or obligation to update
forward-looking statements.
International Stem Cell Corporation
Dr. Russell Kern
EVP, Chief Scientific Officer
(760)940-6383
ir@intlstemcell.com
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