International Stem Cell Corporation to Present Clinical Data at the Society for Neuroscience Annual Meeting
October 30 2018 - 8:30AM
InvestorsHub NewsWire
International Stem Cell
Corporation to Present Clinical Data at the Society for
Neuroscience Annual Meeting
CARLSBAD, CA -- October 30, 2018 --
InvestorsHub newsWire -- International Stem Cell Corporation
(OTCQB:
ISCO) (www.internationalstemcell.com)
("ISCO" or "the Company"), a California-based clinical stage
biotechnology company developing stem cell-based therapies and
biomedical products, announced today it will present at the Society
for Neuroscience Annual Meeting (Neuroscience 2018), being held
November 3-7, 2018 in San Diego, CA.
ISCO’s
presentation, titled, “Results of the first cohort of an open
label dose escalating phase 1 study evaluating the safety of a
human neural stem cell-based therapy in Parkinson’s disease,”
will primarily focus on interim data received in its
currently-ongoing Phase I clinical study of its lead candidate,
ISC-hpNSC®, for the treatment of Parkinson's disease. The Company
will issue a press release on Monday, November 5, 2018, detailing
the clinical results being presented.
Event: Neuroscience
2018
Session Title: Parkinson's Disease:
Diagnostics and Clinical Trials
Session Date:Saturday, November 3,
2018
Session Time: 1:00 PM - 2:45 PM
Location/Room:San Diego Convention Center: SDCC
5
ISCO
recently announced it completed dosing the tenth patient in the
Parkinson’s Disease clinical study, currently being conducted at
the Royal Melbourne Hospital in Melbourne, Australia. Six patients
have fully completed the study and entered the extension phase
while two other patients have completed the six-month
evaluation.
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 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 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®. A 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. An extension
phase of the study will evaluate patients every 6 months for 5
additional years.
About Parkinson's
disease
Parkinson's disease 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 as the most common psychiatric symptom. Parkinson's
disease is more common in people over the age of
50.
There
are no approved treatments that restore the damaged dopaminergic
neurons. Medications typically used in the treatment of Parkinson's
disease, levodopa 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. There are over 10 million people
afflicted by Parkinson's disease worldwide. In 2013 Parkinson's
disease 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 neuroregeneration to the dying
dopaminergic neurons of the recipient Parkinson's disease 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 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 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.
Safe harbor
statement
Statements pertaining to anticipated developments,
clinical studies expectations , progress of research and
development, 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, 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 Kern, PhD
Executive Vice President, Chief Scientific
Officer
ir@intlstemcell.com
or
Edison
Advisors
Tirth Patel
Vice President, Investor Relations
(646)653-7035
tpatel@edisongroup.com
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