International Stem Cell Corporation Announces Positive Interim Clinical Results for Parkinson's Disease Clinical Trial
November 13 2017 - 8:30AM
InvestorsHub NewsWire
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International Stem Cell Corporation Announces Positive Interim
Clinical Results for Parkinson's Disease Clinical Trial
Carlsbad, CA -- November 13, 2017 --
InvestorsHub NewsWire -- International Stem Cell Corporation
(OTCQB:ISCO),
a California-based clinical stage biotechnology company developing
stem cell-based therapies and biomedical products, announced today
the positive six months interim results of
the first cohort of Parkinson’s disease (PD) patients receiving 30
million ISC-hpNSC cells in the ongoing clinical study. All patients
in the first cohort are currently meeting the primary endpoint,
which is safety.
“We are already seeing some positive
efficacy results six months post-transplantation in this 12-month
study. While the relatively small sample size makes it difficult to
observe statistically significant differences, the interim efficacy
results are very encouraging. The first dose tested was used to
determine the safety and tolerability of ISC-hpNSC therapy and is
below the optimal therapeutic dose established in our preclinical
studies” commented Russell Kern, PhD, ISCO’s Executive Vice
President and Chief Scientific Officer. “We are
anticipating strong results in the second cohort (receiving a
higher dose of cells) in which two patients have been treated
already. These clinical results build a strong foundation to start
phase II clinical trials in PD and traumatic brain injury, which
are some of the biggest current unmet medical needs” continued Dr.
Kern.
The % OFF-Time, which is the time of day
when levodopa medication is not performing optimally and PD
symptoms return, decreased an average of 24% for the first cohort
at six months post-transplantation. The % ON-Time without
dyskinesia, which is the time of day when levodopa medication is
performing optimally without dyskinesia, increased an average of
19% for the first cohort during the same period. One hundred
percent of the patients improved their mood six months
post-transplantation with an average improvement of 35% in the Beck
Depression Inventory and 33% in the Emotional Wellbeing dimension
of the Parkinson’s Disease Quality of Life Score-39 (PDQ-39). 100%
of patients improved or retained the same cognitive abilities with
an average improvement of 14% in the Cognitive Impairment dimension
of the PDQ-39. Conducting routine daily activities seemed easier
after six months as demonstrated by the average improvements of 22%
in Activities of Daily Living and 15% in Mobility dimensions of
PDQ-39. The Bodily Discomfort dimension of PDQ-39 also improved an
average of 12% after six months. The Unified Parkinson’s Disease
Rating Scale in the OFF period did not improve six months
post-transplantation. Impulsive and compulsive disorders were
diminished, as demonstrated by the 53% reduction in the
Questionnaire for Impulsive-Compulsive Disorders in Parkinson’s
disease. No test article related serious adverse
events have been reported in the clinical trial. There is no
evidence of tumors, cysts, enhanced inflammation or infection.
Furthermore, no Human Leukocyte Antigen antibodies against the
implanted ISC-hpNSC have been detected.
About the Clinical
Study
The Phase I clinical study is a
dose-escalation safety and preliminary efficacy study of
ISC-hpNSC®, intracranially transplanted into 12 patients who have
moderate-to-severe Parkinson's disease. The open-label, single
center, uncontrolled clinical trial will evaluate three different
dose regimens of 30 million to 70 million neural cells. 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 six 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 the Unified Parkinson Disease
Rating Scale (UPDRS), Hoehn and Yahr, among others. Patients will
be followed for 5 additional years to monitor safety and
progression in neurological assessments.
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 PD 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 walking.
Later, thinking and behavioral problems may arise, with dementia
commonly occurring in the advanced stages of the disease, with
depression being the most common psychiatric symptom. PD most
commonly occurs with people over the age of 50.
Currently, medications typically used in
the treatment of PD, L-DOPA and dopamine agonists, improve only
early symptoms of the disease. As the disease progresses and
dopaminergic neurons continue to diminish, drugs eventually become
ineffective while at the same time, frequently producing a
complication marked by involuntary fidgeting movements. In 2013, PD
resulted in about 103,000 deaths globally, up from 44,000 deaths in
1990.
About
ISC-hpNSC®
ISCO’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.
ISCO 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
pluripotent human 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 hundreds of millions of individuals of
differing genders, ages, and racial backgrounds 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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Safe harbor
statement
Statements pertaining to anticipated
developments, expected results of clinical studies, potential
applications of ISC-hpNSC® to other diseases, progress of research
and development initiatives, and other opportunities for the
company and its subsidiaries, along with other statements about the
future expectations, beliefs, goals, plans, or prospects expressed
by management constitute forward-looking statements. Any statements
that are not historical fact (including, but not limited to
statements that contain words such as "will," "believes," "plans,"
"anticipates," "expects," "estimates,") should also be considered
to be forward-looking statements. Forward-looking statements
involve risks and uncertainties, including, without limitation,
risks inherent in the development and/or commercialization of
potential products (including clinical trial results that differ
from expectations based on earlier studies), regulatory approvals,
need and ability to obtain future capital, application of capital
resources among 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.
Contacts:
International Stem Cell
Corporation
Russell A. Kern, PhD
EVP, Chief Scientific Officer
Phone: 760-940-6383
Email: ir@intlstemcell.com
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