A news story out this week
(http://dtn.fm/SW1v5) in the MIT Technology Review recounts the lamentable tale
of a man (Jim Gass) who used to be chief legal counsel for storied electrical
manufacturer Sylvania – for whom a desperate search to treat his stroke with
stem cells abroad invariably led to disastrous medical tourism results. Based
on a study conducted by the New England Journal of Medicine, the MIT Tech Rev
article’s analysis further explains that the Gass case may have occurred in
part due to Google parent company Alphabet (NASDAQ: GOOG; GOOGL), as the search
engine’s paid ad returns to user queries about stem cell therapies seem partly responsible
for steering people into the hands of shady clinics abroad.
I don’t know what that tells
commercial investors about how midcap and microcap biotech innovators are
overlooked, but it tells me everything I need to know about the future of the
stem cell sector, because the next decade is primed to witness unprecedented
change due to emergent technologies.
This single case with Gass,
where a man sought fetal tissue injections in countries like Argentina, China
and Mexico, because he did not have access to domestic treatment options,
paints a bold and cautionary tale about medical tourism. But it also tells a
story about market potential and the huge sums of capital seeking therapy, that
is currently trapped, like a spring that is ready to bounce, charged with
breakout momentum. Think about Gass: the poor guy just wanted to offset the
impact of his stroke and ended up with a tumor made of someone else’s tissue in
his spine. Now, the former chief legal counsel for Sylvania is no schlub mind
you, so this could happen to any consumer put in a similarly desperate
situation. And Gass reportedly spent over $300,000 in the aggregate seeking
treatments.
Let’s face the facts. We have
been dragging our feet on stem cell technologies for far too long despite the
massive bluesky therapeutic potential (especially when we bring personalized
medicine vectors into the equation), so in many ways we created the problem.
Only in recent years has the FDA begun to change its stance, and so we are late
to the game on this one. While due in part to justifiable ethical concerns, the
resulting sluggishness of our biotech sector has only been exacerbated by the
FDA’s foot-dragging. However, with homegrown companies like revolutionary
California-based biotech developer, International Stem Cell Corp. (OTCQB:
ISCO), effectively in-play as the FDA continues to loosen its grip, this
cautionary tale about Gass could soon go the way of the dinosaur.
The FDA cleared ISCO’s
proprietary human parthenogenetic stem cell line for investigational clinical
use back in 2014, and the company subsequently made significant headway across
its continuously evolving therapeutic pipeline, where two of the current major
vectors are Parkinson’s disease and ischemic stroke (the most prevalent type).
In fact, the company just announced the results of its 12-month pre-clinical
safety and efficacy primate study of its proprietary and readily expandable
ISC-hpNSC® (human parthenogenetic stem cells-derived neural stem cells)
platform, as being published in the well-respected and peer-reviewed journal,
Cell Transplantation.
This publication marks the
end of preclinical work for ISCO’s Parkinson’s disease program and confidence
is now high at the company, with clinical trial approval of ISC-hpNSC® for the
treatment of Parkinson’s disease secured, and Phase 1 clinical trial enrollment
underway in Australia. Patients with moderate to severe Parkinson’s are cleared
by the Melbourne Health Human Research Ethics Committee and ISCO’s
groundbreaking study is being conducted at the Royal Melbourne Hospital in
Australia. Great news, especially when one considers the results of a new
landmark Mayo Clinic study (http://dtn.fm/3E6wT) published in JAMA Neurology,
which shows a big uptick in Parkinson’s rates from 1976 to 2005, a trend whose
forward projections look brutal, even in a best case scenario.
Given the extant evidence
thus far showing that ISC-hpNSC improved Parkinson’s disease symptoms markedly
in subjects, where dopaminergic neuron mass increased significantly, even as
dopamine concentrations rose amid clear neurotrophic support from the therapy –
the potential for the company’s neural stem cells in stroke demands a second
look as well. It should come as no shock, even to lay investors, that the same
kind of injectable ISC-hpNSC therapy able to address Parkinson’s disease can be
used to also treat stroke. However, the actual data the company has put
together to date on the efficacy of such treatment paints a far more compelling
picture.
Being that the standard of
care currently involves attempting to dissolve the blood clot within the first
few hours after the initial event, followed up by only marginally effective and
often extremely challenging rehabilitation work aimed at returning as much
cognitive and functional capacity as possible to the patient – the advent of an
actual stem cell-based therapy could change the stroke market completely. The
National Stroke Association indicates that stroke is the fifth leading cause of
death in America and that it is a leading cause of adult disability, alongside
other neurological diseases/disorders such as Parkinson’s. According to a new
Persistence Market Research report, North America continues to be the largest
market by far for stroke diagnostics and therapeutics, with Asia set to
experience high levels of growth in the next few years. This outlook jogs well
with Transparency Market Research’s most recent publication on the sector,
which projects a market worth $1.9 billion by 2020, growing at a CAGR of around
6.3 percent.
Pre-clinical data suggests
that ISCO’s neural stem cell therapy approach not only addresses but can
actually reverse the functional deficits associated with a stroke. What’s more,
rather than needing to be applied within hours, the therapeutic benefits from
such neural stem cell therapy can be accessed days, or even weeks after the
stroke has occurred.
The advent of ISCO’s neural
stem cell therapy would be a complete and total paradigm shift in the
healthcare market when it comes to treating stroke, and the company is right
here in our own backyard. Throw away your medical tourism passport America, and
double down on ISCO.
For more information, visit
www.internationalstemcell.com
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