The fact that novel stem cell therapy developer,
International Stem Cell (OTCQB: ISCO), is now rapidly advancing from highly
successful preclinical studies in Parkinson’s Disease (PD) using human
parthenogenetic neural stem cells (hpNSC) derived from its proprietary stem
cell technology platform toward a landmark phase 1/2a clinical study clinical
study in Australia, has sparked renewed interest in the investment community
regarding the company’s technology. After the publication of data on two proof
of concept PD studies, demonstrating the safety and functional efficacy of the
company’s human parthenogenetic stem cells (hpSCs) – an entirely new class of
stem cells created using unfertilized eggs which substantially addresses the
problem of cell transplant immune-rejection – the fundamental viability of
ISCO’s hpSC approach and the potential for the upcoming clinical trial in PD
have caused many in the investment community to dig deeper into ISCO’s dynamic
platform.
Given the recent projection by research and consulting firm
GlobalData that the PD treatment market alone will continue to grow alongside
an ageing global population, running a CAGR of around four percent over the
next several years, before hitting around $5.3 billion in 2022, the development
of a viable treatment option by ISCO could be a major victory for the company
and for patients; a victory which would also broadly legitimize the company’s
existing clinical pipeline, while adding fuel to the fire of its existing
commercialization. It is important to note that when it comes to PD, leading
dopamine agonists like pramipexole and ropinirole, or Neupro/Leganto
(rotigotine), work by merely imitating dopamine, stimulating the brain in a
similar fashion and thus making up for the dopamine-producing cells that have
died due to the onset of PD.
Dopamine agonist regimens do not represent a real treatment
and merely mask the underlying disease. While such PD regimens return some
percentage of motor and cognitive control to the patient, they are a far cry
from the demonstrated ability of ISCO’s transplanted hpNSCs to both actively
differentiate into new dopamine-producing neurons and simultaneously act as a
neuroprotectant, addressing both the patient’s current symptoms and helping to
stop further deterioration. ISCO’s approach is closer to that of regenerative
medicine company Neuralstem, Inc. (NYSE: CUR), whose initial therapeutic product,
derived from spinal cord neural stem cell lines, has received FDA orphan status
for application in ALS, more commonly known as Lou Gehrig’s disease.
In ISCO’s case, the derivation and implementation
methodologies are of particular interest, especially given the immune-matching
aspects of the technology and its scalability potential, both in terms of
producing large quantities of stem cells for transplant and with regard- to addressing therapeutic avenues beyond the
scope of the company’s current clinical pipeline. As the company moves out of
the preclinical stage in its work on PD using hpNSCs, which have also shown
significant promise as a legitimate treatment option for actually reversing the
functional deficits associated with a stroke, when administered even weeks
after the actual event, it makes sense to take a look at ISCO’s already
functional commercial operations based on its stem cell platform technology.
This is especially true given the company’s ongoing work with hpSC-derived
human retinal epithelium (RPE) cells for treating retinal and corneal
blindness, as well as its stem cell-derived liver cell (CytoHep) program, which
is focused on developing metabolic liver disease therapies.
A solid five percent sales uptick for Q1 this year compared
to 2014 reported by the company’s Lifeline Skin Care subsidiary – which
leverages the same ethically-derived stem cell platform technology to create an
extract for use in skin care products that have demonstrably shown an ability
to improve elasticity, firmness, tone and other sought-after qualities – is a
solid indicator of the company’s existing ability to generate revenue from its
technology, even before commercialization of the clinical pipeline has been
realized. With the global facial skin care market on track to hit somewhere in
the neighborhood of $40 billion by 2019 (Transparency Market Research), driven
in part by the fact that more and more men are beginning to show an increased
awareness of and concern for their skin’s health, ISCO’s capacity to bring
revolutionary products to market based on far more potent non-embryonic stem
cells than the adult stem cells used by many other entrants to this burgeoning
segment of the skin care market, has already placed the company in a class all
its own.
A full lineup of facial skin care products, including an
antioxidant polisher, brightening cleanser and exfoliating preparation, roundly
back up Lifeline Skin Care’s eye firming complex and revitalizing moisture
serum products, which are made possible by a nanotech encapsulation of the stem
cell extract’s key proteins. This unique encapsulation of the proteins in an
oily two-layer sphere, allows Lifeline products to penetrate deep into the
middle layer of the skin, the dermis, where collagen and elastin (the main
structural and elastic peptides that give the skin its youthful qualities) are
produced.
Lifeline Skin Care customers rave about the results,
expressing most often how much lighter and brighter their skin looks and feels.
Given the continued success of the company’s clinical pipeline and the
demonstrable efficacy of hpSCs in treating notoriously difficult CNS conditions
like PD, it is not hard to understand why Lifeline Skin Care products have become
so beloved by consumers. The idea of actually replacing skin proteins with
high-potency, nanotech encapsulated, small-molecule and therefore readily
absorbed proteins is a significant technological leap beyond what other stem
cell-based skin care companies have been doing. Clinical laboratory studies
showing a 46 percent increase in elastin, and a 48.5 percent on average
increase for the two primary types of collagen when using Lifeline stem cell
products, adds readily quantifiable weight to the documented expressions by
consumers about how their skin feels brighter, more luminous, and healthier
after using the products.
Operating income for ISCO from both aforementioned
cosmeceutical commercialization and the company’s ongoing biomedical
commercialization, which is executed under the company’s Lifeline Cell
Technology subsidiary, was up some 76 percent in Q1 this year compared to 2014.
Lifeline Cell Technology has quickly become an industry leader in supplying
purified primary human cells and optimized cell culture reagents, and while
this market is not as immediately lucrative as skin care, the long-term revenue
generation potential as the stem cell industry evolves is considerable in its
own right. With the best Q1 financial performance owing to the company’s
cosmeceutical division, investors should take note of ISCO’s ability to
generate revenues well before its clinical pipeline achieves commercialization,
a feat of which very few young biotechs can boast.
Cancer is another huge area where we could see such
technology revolutionize the way therapy is handled. Stem-cell transplantation
following high-dose chemotherapy for instance, has emerged as an established
treatment modality for a variety of hematologic malignancies, such as leukemia,
lymphoma, and multiple myeloma. The company’s capacity to produce large volumes
of immune-matched stem cells using its proprietary parthenogenetic derivation
technology, at its GMP facility in Oceanside, California, is a key strategic
and logistical advantage here as well. Even such innovators like clinical-stage
biopharma BioLineRx (NASDAQ: BLRX) – which recently announced robust stem-cell
mobilization capability with its lead oncology candidate, allowing for
harvesting of enough cells needed to transplant from healthy volunteers into
patients with hematological malignancies – are notably handicapped by
comparison when it comes to cell source logistics.
Learn more about the company by visiting
www.internationalstemcell.com
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