International Stem Cell Corporation Announces Second Patient with Parkinson's Disease Treated in Phase I Clinical Trial
(Thomson Reuters ONE) -
- Second patient of first cohort treated with ISC-hpNSC -
CARLSBAD, Calif., Dec. 07, 2016 (GLOBE NEWSWIRE) -- International Stem Cell
Corporation (OTCQB:ISCO), a California-based clinical stage biotechnology
company developing stem cell-based therapies and biomedical products, today
announced the treatment of the second patient in the Australian trial for
Parkinson's Disease. The patient was injected with 30,000,000 ISC-hpNSC(®) cells
and is currently recovering.
The surgery was performed on Sunday, December 4, at the Royal Melbourne Hospital
(RMH), the same site as the first treatment. The operation was successfully
performed without complications by the team of the RMH neurosurgeons.
"We are very encouraged by how the clinical trial is moving ahead," commented
Russell Kern, PhD, executive vice president and chief scientific officer of
ISCO. "The second operation was delayed by a supply chain disruption of
equipment critical to the operation, but we have managed to fix the issue and
bring the clinical trial back on track. In addition, we have identified patients
to be enrolled in the trial and are working to get them treated in 2017."
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 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(TM). 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, 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 VP, Chief Scientific Officer
Phone: +1 760 940 6383
Email: ir(at)intlstemcell.com
Alex Fudukidis
Russo Partners
Tel.: +1 646 942 5632
E-mail: alex.fudukidis(at)russopartnersllc.com
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: International Stem Cell Corporation via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 07.12.2016 - 14:30 Uhr
Sprache: Deutsch
News-ID 511480
Anzahl Zeichen: 8774
contact information:
Town:
Carlsbad, CA
Kategorie:
Business News
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