Stem cell technology’s real untilled and still extremely
fertile soil is the therapeutics market, where injected cells could help repair
damaged tissue systems and thus effectively treat many conditions, including
degenerative ones, for which the current standard of care is often palliative
at best. Dealing with the underlying cause of a given condition, through the
gradual replacement and/or reinforcement of an impaired tissue system or organ
using injected stem cells, represents a true paradigm shift in how we think
about treating many of today’s most debilitating diseases. However, to tap into
the rich spoils of this as yet largely undiscovered country, requires a mix of
technologies and logistical capabilities, of which tragically few companies
today can seriously boast.
One company that doesn’t need to boast, as it has clearly
achieved both the capacity to proprietarily differentiate adult human cells by
chemically stimulating unfertilized donor eggs, as well as provide long-term,
storable, high-quality stem cell product for real-world, commercial-scale
therapeutic applications, is International Stem Cell Corp. At the core of the
company’s pipeline of rapidly emerging therapeutics is its parthenogenesis
technology, whereby the company can create large batches of pluripotent (able
to develop into any type of cell), human parthenogenetic stem cells (hpSCs),
and do so in a completely ethical fashion. The company’s proprietary
stimulation and differentiation technology also helps resolve the one major
stumbling block facing stem cell therapies, immune rejection by the host. The
company’s ability to make large batches of adult human cells from stem cells
that are either specifically immune-matched to the donor, or immune-matched to
the general population, gives ISCO an open road to therapy development, and the
company has the testing to back up its technology too.
ISCO’s nine-month, 300 subject rodent model safety study,
testing the tumorigenicity (propensity to promote tumor formation/growth) of
its human neural stem cells (hpNSCs), which have been developed for the
treatment of Parkinson’s disease (PD), was submitted back in July as part of
the build up to phase 1/2a human clinical trials in Australia. This study
followed up on earlier results by ISCO with its hpNSCs, showing no tumors in
any of the animals receiving neural stem cell transplants. The demonstrated
ability of injected hpNSCs to create new neurons that produce the primary
neurotransmitter, dopamine (with whose falloff PD is causally associated), as
well as exhibit a neuroprotectant effect on surviving neurons makes this
technology a potential gold mine if human clinical trials yield good results.
Given that PD is a progressive, degenerative disorder, and
that the current standard of care, oral levodopa (L-dopa), is associated with
progressively worse periods where symptoms manifest themselves fully, called
“off” periods, there hasn’t really been a good long-term solution for
addressing the unmet needs of a majority of PD patients. This majority of PD
patients, for whom the current standard of care so often feels like they are
just postponing the inevitable succumbing to the disease’s impairments, are
plagued by the frequency and intensity of relapse periods increasing as the
disease progresses using L-dopa. ISCO isn’t trying to mask the problem
chemically with synthetic dopamine, the company has developed injectable replacement
neurons to treat the underlying brain tissue degeneration, and hopefully
actually restore full functionality to the patient.
According to a new study out by research and consulting
firm, GlobalData, the PD treatment market for just the U.S., Brazil, Japan, and
the major EU member states is on track to hit upwards of $4.7 billion by 2022.
However, newly FDA-approved market entrants, such as Xadago (safinamide) – a
drug which blocks the primary enzyme which break down dopamine, from Zambon and
its SIX Swiss Exchange-traded partner Newron Pharmaceuticals (SWX: NWRN) – or
Impax Laboratories’ (NASDAQ: IPXL) RYTARY, an extended-release oral capsule
formulation of carbidopa-levodopa – still do not address the underlying causes
of the disease. It is up to a company like ISCO to bring forth a real
therapeutic treatment option here, with ethical stem cell technology that can
actually regenerate the damaged tissue system(s). With PD, given its
progressive nature, it is not unthinkable that periodic injections, or simply a
thorough course of therapeutic treatments with hpNSCs, could restore the
patient to full functionality.
A good indicator of this potential is ISCO’s parallel hpNSC
therapy pipeline for stroke, where preclinical data indicates that injections
administered even several weeks after the stroke could actually reverse the
typically associated functional deficits completely. The alternative to such a
therapy in the case of a stroke is often grueling physical therapy, required in
order to get back or re-learn lost motor function. But with ISCO’s treatment
option on the table, stroke could be handled in the future with a simple
injection regimen, even well after the initial stroke hospitalization. The
tremendous potential of hpNSC therapy in strokes speaks volumes about what that
same therapy can do for PD patients, given that both are maladies of the CNS,
and that the therapy functions by replacing damaged neurological tissue.
To dig deeper, visit www.internationalstemcell.com
About QualityStocks
QualityStocks
is committed to connecting subscribers with companies that have huge potential
to succeed in the short and long-term future. We offer several ways for
investors to find, evaluate, and learn more about investing in these companies.
The Quality Stocks Daily Blog http://blog.qualitystocks.net
The Quality Stocks Daily Videos http://videocharts.qualitystocks.net
The Quality Stocks “Ones to Watch” http://gotstocks.qualitystocks.net
Please see disclaimer on the QualityStocks website: http://disclaimer.qualitystocks.net
No comments:
Post a Comment