With the recent announcement from Australia’s version of the
FDA, the Therapeutic Goods Administration, that pluripotent stem cell
manufacturing innovator International Stem Cell Corp. (OTCQB: ISCO) has been
cleared to start Phase I/IIa dose escalation clinical trials focused on the
safety and efficacy of its human parthenogenetic neural stem cells
(ISC-hpNSCs), the company has taken another major step toward a real
therapeutic solution to Parkinson’s disease. An incurable condition that
primarily affects the planet’s growing elderly population, Parkinson’s
currently afflicts well over 10 million people worldwide and represents a
therapeutics market somewhere in the neighborhood of $2.6 billion.
However, while the sale of extant therapeutics will continue
to be dominated by mere dopamine agonists and an increasing use of MAO-B
inhibitors (historically used to treat depression), such treatments are
palliative at best, and sales will be substantially impacted by the rapid
proliferation of generics. Even the newer agents coming down the industry’s
pipeline through to 2020, such as a reformulated levodopa from Impax
Laboratories (NASDAQ: IPXL) and GlaxoSmithKline (NYSE: GSK), or the MAO-B
inhibitor safinamide being developed by Merck (NYSE: MRK), Newron (OTC: NWPHF)
and EMD Serono, will be forced to compete with generics.
ISCO, on the other hand, has the inside track in this market
with an injectable cellular therapy that is potentially capable of actually
replacing dead and dying neurons in the midbrain, while directly offsetting
Parkinson’s symptoms. This solution also offers substantial protection to
surviving neurons, shielding them from further deterioration. Considerable
pre-clinical animal model testing has already shown extremely promising results
and the progress ISCO is set to make via the Phase I/IIa clinical trial in
humans could propel the company to stardom as the first to develop an actual
solution for Parkinson’s sufferers.
This same technology, because it employs high purity
functional adult human cells that have been created from unfertilized donor
eggs at the company’s state-of-the-art Oceanside, California, facility using an
ethical, patented chemical differentiation process, could also evolve into
frontline treatments for other CNS (central nervous system) maladies such as
Alzheimer’s and stroke. The FDA’s recent IND approval of Stemedica’s allogeneic
(same species but genetically dissimilar and generally immunologically
incompatible) stem-cell therapy for a Phase IIa clinical study in Alzheimer’s
at UC San Diego shows how much potential there is for this kind of technology,
and how receptive the FDA has become to stem cell technology.
ISCO’s ability to manufacture commercial-scale batches of
both precisely human leukocyte antigen-matched (HLA) and therefore
histocompatible human parthenogenetic stem cell lines, as well as
HLA-homozygous lines that are suitable for significant segments of the overall
population, gives the company a real edge here as well. Stemedica’s allogeneic
stem cells, for instance and by contrast, are cultivated from donor tissues,
not differentiated from unfertilized eggs. Thus, ISCO’s technology is quite
remarkable, because it substantially overcomes one of the main challenges
facing stem cell therapeutics as a viable solution to numerous diseases;
namely, cell rejection by the patient’s immune system.
International Stem Cell Corporation could be first to market
a treatment actually capable of halting the progression of Parkinson’s disease
in its tracks, or even reversing the impact of the disease. Results from the
company’s landmark human clinical trial should start to become available in the
coming months and investors should keep a close eye on ISCO for breaking news.
For more information, visit www.internationalstemcell.com
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