International
Stem Cell Corporation (OTCQB:ISCO), a California-based clinical stage
biotechnology company developing stem cell-based therapies and biomedical
products, today announced that its Chief Scientific Officer, Russell Kern, PhD,
will deliver an oral presentation on the Company's Parkinson's disease clinical
trial at the American Society of Gene & Cell Therapy 20th Annual Meeting at
the Marriott Wardman Park in Washington, DC.
Session
Information
Session
Date/Time: Thursday
May 11, 2017 3:45 PM - 5:15 PM
Session title: Clinical
Trials for Neurologic and Neurosensory Disorders
Room: Marriott
Salon 1
Presentation
Time: 5:00pm
- 5:15pm
Presentation
title: Update
on the First-in-Human Clinical Study Evaluating Neural Stem Cells in Patients
with Parkinson’s Disease
Session
Date/Time: Thursday
May 11, 2017 3:45 PM - 5:15 PM
Session title: Pharmacology,
Toxicology and Assay Development
Room: Maryland
ABC
Presentation
Time: 3:45pm
- 4:00pm
Presentation
title:
Pharmacology and Toxicology Studies Conducted for the First-in-Human Clinical
Study of Neural Stem Cells in Parkinson’s Disease
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 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, expected results and timing 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
Phone: 760-940-6383
Email: ir@intlstemcell.com
http://health.einnews.com/pr_news/379340233/international-stem-cell-corporation-to-present-results-of-neural-stem-cell-transplantation-for-parkinson-s-disease-at-the-asgct-2017-annual-meeting
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