In the U.S. alone each
year somewhere around 60k people are diagnosed with the crippling degenerative
central nervous system (CNS) disorder known as Parkinson’s disease, which is
brought on by an as-yet poorly understood cascade death of dopamine-generating
cells in the midbrain. Roughly 0.3% of the entire population, or nearly one
million Americans, currently lives with this life-shattering disorder. That’s
more than multiple sclerosis, muscular dystrophy, and Lou Gehrig’s disease
combined.
Parkinson’s is the kind of
CNS disorder that can destroy an entire family, devastating a family member and
rendering them unable to effectively care for themselves, as the disorder is
most commonly characterized by severe diminishment of motor control, uncontrollable
limb rigidity and shaking, as well as considerable difficulty just walking or
moving around. Later on in the progression of Parkinson’s, sensory and
emotional problems arise, with sleep deprivation and depression being all too
common. Eventually, the patient often develops thoroughly debilitating dementia
as well and Parkinson’s has become a dreaded thief that can rob a family of
their loved ones, and for which there are currently only extremely
limited/costly treatment options.
Worldwide the incident rate
is more difficult to get a handle on, but the Parkinson’s Disease Foundation
estimates that as many as 10 million people worldwide are currently afflicted
and that in the U.S., total direct and indirect costs, including treatment and
lost wages, amounts to around $25 billion each year. With medications to help
patients cope running around $2.5k a year for most and only somewhat effective
therapeutic surgeries running somewhere in the neighborhood of $100k, there is
immense demand for a more effective and less invasive solution.
International Stem Cell
Corp. (OTCM:ISCO), a small publicly-traded biotech developer based in
California with around 47 full-time employees, 23.4% of whom are Phd/MDs, may
have just such a solution in the works thanks to their decade-plus pioneering
in ethical pluripotent stem cell technology. The company’s proprietary human
parthenogenetic stem cell (hpSC) platform technology, which is clearly
differentiated from induced pluripotent stem cell (iPS) technology due to zero
manipulation of the cellular genome and thus does not bear the safety and
regulatory burdens associated with iPS approaches, is now rapidly advancing
towards ISCO’s first clinical product, human parthenogenetic neural stem cells
(hpNSC).
Recently vindicated in the
EU via a final and definitive ruling by the EU’s highest court, the Court of
Justice of the European Union, in a decision which roundly confirmed the
earlier opinion issued by the Advocate General in 2014, the company’s core
technology patent applications are not prohibited, or even covered under the
EU’s prohibition on patenting embryonic stem cells. This decision clears the
way for commercial rollout in the Eurozone of ISCO’s rapidly advancing hpNSC
technology, as parthenogenetic stem cell’s legally patentable status is now
clearly differentiated from still-banned embryonic stem cell patenting.
Earlier this month, the
company was pleased to announce that they have successfully completed
manufacturing the requisite cell bank for their upcoming Phase 1/2a clinical
trials in Parkinson’s, having produced in excess of 2.6 billion clinical-grade
human neural stem cells, which is more than enough to cover all foreseeable
clinical needs, utilizing the company’s patented hpNSC production process. The
company’s highly-optimized and chemically-defined differentiation production
process was published in a Nature publication in 2013 and ensures that all
hpNSCs are manufactured according to strict cGMP-compliant conditions and that
these high purity cells are effectively cryopreserved.
This platform and
production technology puts ISCO at the forefront of hpSC science today and
makes this publicly-traded biotech company a real up-and-comer for investors to
keep a close eye on, as their hpSC platform and production architecture’s
potential goes well beyond just developing Parkinson’s treatments. The company
is also currently developing hpNSCs for ischemic stroke, a leading cause of
death in the U.S., which claims over 130k lives each year and which represents
over 87% of all stroke cases caused by a clot in a blood vessel that supplies
the brain.
Treatment options are very
limited for ischemic stroke sufferers and while dissolving the blood clot
within two to three hours after the acute phase has shown to be effective,
often severe debilitation can occur and extensive rehabilitation is necessary
to recover (some, generally not all) cognitive and motor functions. With around
800k cases of stroke each year in the U.S., effectively costing (direct and
indirect) over $74 billion, the demand for ISCO’s hpNSC solution is potentially
even greater here than it is for Parkinson’s.
With compelling
pre-clinical evidence that NSC treatment can actually reverse the debilitation
caused by a stroke, even when it is utilized several weeks after the initial acute
phase of the stroke, ISCO’s highly purity hpNSC solution could emerge as the de
facto treatment option for ischemic strokes and seriously help patients to ably
recuperate from an otherwise potentially crippling incident. Looking at the
company’s hpNSC clinical development pathway for such CNS issues as Parkinson’s
and ischemic stroke, it is pretty easy to see that additional cell therapy
treatment options for other CNS diseases and disorders can be developed using
this technology.
ISCO is dedicated to
developing new treatment options for CNS diseases, as well as those of the
liver and eye where such cell therapy has demonstrated efficacy, but where
options are currently limited by a lack of readily available, safe human cells.
The company’s ability to readily produce high purity stem cell-derived liver
cells (CytoHep), as well as human retinal epithelium (RPE) cells and human
corneal cells/whole corneal tissue (CytoCor) from human parthenogenetic stem
cells, puts their development pipeline potentially within eventual striking
distance of treating a vast array of conditions. Conditions like the metabolic
liver disease Crigler-Najjar syndrome, which can lead to severe brain and
nervous system damage (as well as death), as well as eye conditions like age-related
macular degeneration, which causes vision loss and blindness in as many as 50
million people around the world today.
Learn more about the
company by visiting www.internationalstemcell.com
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