International Stem Cell Corporation Doses 7th Patient in Clinical Trial for Parkinson's Disease
November 29 2017 - 8:30AM
InvestorsHub NewsWire
Carlsbad, CA
-- November 29, 2017 -- InvestorsHub NewsWire
-- International Stem Cell Corporation (OTCQB:ISCO)
(www.internationalstemcell.com) (“ISCO”
or “the Company”), a California-based clinical stage biotechnology
company developing novel stem cell-based therapies and biomedical
products reported today that a third patient of the second cohort
with Parkinson's disease was successfully transplanted with
ISCO's proprietary ISC-hpNSC® cells. The operation was
successfully performed by the team of the Royal Melbourne
Hospital’s neurosurgeons without complications.
"We are very encouraged by how the
clinical trial is progressing," commented Russell Kern, PhD,
ISCO's Executive Vice President and Chief Scientific Officer.
"We anticipated positive results from the beginning and this trial
continues to meet our high expectations. We foresee only promising
results in the months to come” he continued.
About the Clinical
Trial
The Phase I clinical trial 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,"
“forsee,” "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.
International Stem Cell
Corporation
Dr. Russell Kern
EVP, Chief Scientific
Officer
(760)940-6383
ir@intlstemcell.com
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