International Stem Cell Corporation Granted Key Patent in US
May 07 2018 - 8:30AM
InvestorsHub NewsWire
International Stem Cell
Corporation Granted Key Patent in US
CARLSBAD, CA. -- May 7, 2018 -- InvestorsHub NewsWire --
International Stem Cell Corporation (
OTCQB:
ISCO) (
www.internationalstemcell.com)
("ISCO" or "the Company"), a California-based biotechnology company
developing novel stem cell based therapies and biomedical products,
announced today that the United States Patent and Trademark Office
(USPTO) has granted the Company a key patent (US9926529B2) on the
method used to manufacture
ISC-hpNSC. These arethe cells administered
in ISCO’s ongoing Parkinson’s disease clinical trial, and they can
potentially be utilized in therapies to treat traumatic brain
injury and stroke. This patent covers the procedure where human
pluripotent stem cells (hPSCs), which have the potential to
differentiate into essentially all cell types in the human body,
are chemically differentiated into neural stem cells (NSCs),
self-renewing cells that generate the neurons and glia of the
central nervous system.
The new technique developed by ISCO’s scientists outperforms the
traditional methods because it produces a more pure population of
NSCs, generating NSCs that are over 95% pure, as opposed to
traditional methods that only yield purities of around 80%. In
addition, ISCO’s method is automatable and less labor
intensive.
"Year after year, ISCO continues to strengthen its position as a
leader in the field of regenerative medicine and explore the full
potential of hPSCs,” said Russell Kern, PhD, ISCO's Executive Vice
President and Chief Scientific Officer. "This new patent adds to
the strong intellectual property of the company and positions us to
extend our scientific reach to new heights," he
continues.
Generating NSCs from hPSCs has proved to be a scalable method that
is easily adapted for manufacturing under GMP (Good Manufacturing
Practices). With this method, ISCO has developed both master and
working cell banks of ISC-hpNSC®under GMP. These banks have undergone
quality control release testing for sterility, purity, identity,
potency, and safety before being utilized in the clinic.
The cells manufactured through this process are absent of residual
pluripotent stem cells, have a normal karyotype and are negative
for bacteria, fungal, mycoplasmal, and adventitious viral
contaminants, which is critical to assure their safe use in the
clinic.
ISCO also conducted a series of pre-clinical studies with these
cells and demonstrated the absence of teratomas and tumorigenic
cells, and these findings have been published in various
prestigious peer-reviewed journals. This shows that the cells are
not associated with any proliferative risk or other serious adverse
event, which is critical for the translation ofISC-hpNSC®into viable therapies that could
potentially be delivered to millions of patients suffering from
Parkinson’s disease and other neurological diseases around the
world.
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 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®. 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).
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Safe harbor
statement
Statements pertaining to anticipated
developments, clinical studies expectations (including timing and
results), progress of research and development, the potential use
of ISC-hpNSC in other therapies 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 A. Kern, PhD
Phone: 760-940-6383
Email: ir@intlstemcell.com
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