International Stem Cell Corporation Doses Tenth Patient in Parkinson's Disease Clinical Trial
08 Octobre 2018 - 2:30PM
InvestorsHub NewsWire
Carlsbad, CA -- October
08, 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
that the second patient of the third cohort of the clinical trial
for Parkinson's disease was successfully transplanted with
70,000,000 ISC-hpNSC®
cells.
The surgery, which was
performed by a team of neurosurgeons at the Royal Melbourne
Hospital in Melbourne, Australia, proceeded without complications
and the patient was discharged soon
after.
"We are pleased to
provide an update regarding the progress of our Parkinson's disease
clinical trial," commented ISCO's Executive Vice President and
Chief Scientific Officer Russell Kern, PhD. "This is the second
patient receiving the highest dose, bringing the total to 10
patients transplanted with ISC-hpNSC® cells. Based on the available
clinical data, we are confident that the therapy is safe,
well-tolerated, and can potentially improve the quality of life of
the patients," he continued.
Six patients have now
fully completed the study and entered the follow-up phase while two
other patients have completed the six-month evaluation. The
treatment phase of the study will conclude following the dosing of
the last two patients of the third cohort, which ISCO plans to
complete soon.
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). More information is available at
www.internationalstemcell.com.
To subscribe to receive
ongoing corporate communications, please click on the following
link:
http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0
To like our Facebook
page or follow us on Twitter for company updates and industry
related news, visit:
www.facebook.com/InternationalStemCellCorporation and
www.twitter.com/intlstemcell
Safe harbor
statement
Statements pertaining
to anticipated developments, clinical studies expectations
(including timing and results), 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
Phone: +1 760 940 6383
Email: ir@intlstemcell.com
International Stem Cell (QB) (USOTC:ISCO)
Graphique Historique de l'Action
De Nov 2024 à Déc 2024
International Stem Cell (QB) (USOTC:ISCO)
Graphique Historique de l'Action
De Déc 2023 à Déc 2024