International Stem Cell Corporation to Move Forward with Traumatic Brain Injury Phase II Clinical Trial
September 20 2017 - 8:30AM
InvestorsHub NewsWire
Carlsbad, CA -- September 20, 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, announced
today that the completion of its preclinical studies in Traumatic
Brain Injury (TBI) program will position it to commence a Phase II
clinical trial in Australia under the Clinical Trial Notification
scheme.
“Often referred to as a silent epidemic, TBI represents a
significant unmet medical need with millions affected annually.
Based on the results of our proprietary ISC-hpNSC® demonstrated in
our Parkinson’s disease clinical trial and in the preclinical
studies conducted by the world-renowned academic collaborator, we
believe ISC-hpNSC® can be an effective therapy for TBI” remarked
Andrey Semechkin, PhD., Co-Chairman and CEO of ISCO.
"We are very impressed by the results of our TBI preclinical
studies. Both motor and cognitive functions improved with neural
stem cells ISC-hpNSC® transplantation without any safety issues”
commented Russell Kern, PhD., Executive Vice President and Chief
Scientific Officer of ISCO. “With the clinical safety data
collected in our Parkinson’s disease program, we are now ready to
submit our regulatory application for a new clinical trial in
another neurological indication. We are planning to evaluate the
efficacy ISC-hpNSC® in a Phase II clinical study in patients with
TBI and we will file a Clinical Trial Notification with the
Australian TGA,” he continued.
ISCO's proprietary ISC-hpNSC® readily expandable neural stem cells
significantly improve cognitive performance, locomotion, and
neurological function in rodents with TBI. The preclinical studies
were conducted by the world renowned Prof. Cesar Borlongan,
Distinguished Professor who serves as the Vice Chairman for
Research, Department of Neurosurgery and Brain Repair and as
Director, Center of Excellence for Aging and Brain Repair at the
University of South Florida Morsani College of Medicine. The
results of these studies demonstrate the therapeutic potential of
ISC-hpNSC® in TBI and should expedite its translation into the
clinic.
There is currently no approved treatment for TBI. TBI is a
leading cause of death and disability in the United States,
contributing to approximately 30% of all injury deaths. According
to the World Health Organization, the global incidence for TBI is
approximately 10 million people annually.
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®.
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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Safe harbor statement
Statements pertaining to anticipated developments, expected results
and timing of clinical studies, progress of research and
development initiatives, potential applications for ISC-hpNSC® 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.
International Stem Cell Corporation
Dr. Russell Kern
EVP, Chief Scientific Officer
(760)940-6383
ir@intlstemcell.com
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