With the success of its nine-month GLP safety
(tumorigenicity) and biodistribution animal model study in Parkinson’s Disease
(PD) showing a completely clean record, as zero tumor growth was observed
across a batch of 300 rodents injected with the company’s ethically and
proprietarily-derived human neural stem cells (hpNSCs), International Stem Cell
Corp. has subsequently taken a major step to increase the company’s market
presence and up-list to a major exchange, announcing a reverse stock split in
order to tighten the overall share structure. Since the July 29 split
announcement, the company’s ticker has been ISCOD, and it will remain so until
the typical period of approximately 20 days has elapsed.
The recently completed nine month GLP safety study, which
capitalizes on a long track record of successfully demonstrated results
stretching back to such examples as the 2013 work with Duke University’s
Clinical Research Institute, was the last step needed for International Stem
Cell to secure the previously announced landmark phase 1/2a clinical trial in
PD with the Australian Therapeutic Goods Administration via the company’s
recently-formed Australian subsidiary, Cyto Therapeutics Pty Ltd. The company
has quite a preclinical dataset to back up its novel approach to treating PD
with injected hpNSCs, which are self-renewing multipotent precursor cells to
the main types of cells that make up the CNS (central nervous system), created
using the company’s proprietary parthenogenetic technology, which chemically
differentiates unfertilized human eggs (oocytes) into pluripotent stem cells
(capable of giving rise to many different cell types).
This extensive preclinical dataset the company has thus far
amassed, showing zero evidence of tumor formation at even high dosages
(including proof-of-principle PD cohort studies and additional studies focused
on safety), combined with direct evidence that injected hpNSCs exhibit a
neuroprotectant capacity, as well as an ability to actively recover neurons and
address the core motor function symptomatology of PD characterized by dopamine
deficiency, is an extremely positive forward indicator to investors.
International Stem Cell Corporation has been steamrollering forward with
incredible momentum in 2015, ever since the announcement in December of last
year that the EU’s Court of Justice ruled in favor of the company’s core
technology patent applications, declaring them to be effectively outside the
scope of prohibitions on patenting embryonic stem cells, due to a laser-like
focus on only ethical derivation of non-embryonic stem cells from unfertilized
eggs. Ethically-derived sourcing is a key advantage for International Stem Cell
Corporation, especially in the current environment, where a political and
ethical debate about stem cell technology is heating up.
Highlights for the company so far this year include solid Q1
results reported in March, showing a 74 percent uptick in gross margins on the
strength of a 76 percent increase in operating income from the company’s
cosmeceutical and biomedical commercialization. Income growth to $1.62 million
in revenue was led by a 5 percent sales jump at the company’s Lifeline Skin
Care subsidiary, which specializes in providing rejuvenating skin care products
based on nanosphere-enscapsulated proteins extracted from parthenogenetic stem
cells. Additionally, the company made waves in the regenerative therapy
industry with a talk given in May at the International Society for Cellular
Therapy’s (ISCT) annual meeting by the company’s CSO, Ruslan Semechkin, Ph.D.,
highlighting the potential of hpNSCs for treating PD. The ISCT is the leading
global association focused on innovative preclinical and translational cell
therapy product development, and Dr. Semechkin’s talk on hpNSC therapy left a
lasting impression on key industry participants who attended the Regeneration
and Nervous System Repair session at the organization’s 21st annual meeting in
Las Vegas.
This move to reverse split the common stock and up-list to a
major exchange comes at an auspicious time for International Stem Cell
Corporation as the company rockets towards commercialization of a potentially
genuine treatment option for PD sufferers and their families. With GlobalData
estimates on the PD treatment market running into the $5.3 billion range within
the next seven years alone, growing at a compound annual rate of over four
percent, International Stem Cell Corporation is poised to become one of the big
names in PD treatment, especially considering the company’s ample IP position.
The company has made a herculean effort thus far to globally secure its core
technology, as well as specific pluripotent human parthenogenetic stem cell
(hpSC) lines, with 16 issued patents and 91 pending applications spanning 15
patent families, as well as eight more pending applications across four other
patent families related specifically to skin care products. International Stem
Cell Corporation has even licensed an additional portfolio of 11 issued and 14
pending patents/applications covering eight patent families in order to further
secure its broad-spectrum and rapidly developing hpSC treatment pipeline.
This pipeline includes developing the same hpNSCs used to
treat PD, in order to provide stroke patients with the first real solution to
this leading cause of adult disability, and the company already has robust
preclinical evidence that injection of these highly-pure hpNSCs can be used to
actually reverse functional deficits when applied even several weeks after the
initial event. This one development would be a major commercial victory for the
company and it would also largely establish the concrete viability of its
parthenogenetic technology for creating commercial-scale, implant-ready cell
banks for the ischemic (roughly 87 percent of cases) stroke treatment and other
markets. Not to mention being a game-changer for the roughly 691,650 people
every year in the U.S. who suffer from ischemic strokes. People whose only
current option is costly, laborious, logistically difficult to implement, and
often ineffective cognitive/functional rehabilitation. Commercial success in
either PD or ischemic stroke would roundly validate the company’s underlying
therapeutic approach for treating other diseases and disorders as well,
potentially opening a floodgate for the company and allowing them the kind of
financial muscle and industry clout needed to knock down additional targets
with hpSC-based therapies.
The company’s hpSC technology is currently being developed
for areas such as age-related macular degeneration via parthenogenetically-derived
human retinal epithelium (RPE) cell therapy, as well as for corneal blindness
and many other eye diseases/disorders via the production of corneal cells and
whole corneal tissue. This same technology also shows great promise for treating
metabolic (and other types of) liver diseases, such as Crigler-Najjar syndrome
(inherited), and the company has already successfully created and characterized
stem cell-derived liver cells under its CytoHep program, whose transplantation
has been shown to effectively delimit the brain and nerve damage associated
with Crigler-Najjar syndrome in preclinical animal models.
If one observes all of these emerging hpSC treatment vectors
from a wide angle, it becomes strikingly apparent that we could potentially be
treating a whole host of degenerative and other diseases/disorders with 100
percent ethically derived stem cell technology. International Stem Cell
Corporation is at the forefront of this industry and the shoring-up of its
share structure in anticipation of up-listing to a major exchange, in
conjunction with the upcoming landmark clinical trials in PD, for which the
company has already comfortably sustained the cost on and manufactured a cell
bank of over 2.6 billion high-purity hpNSCs (enough to satisfy all foreseeable
clinical trial needs), is an extremely bullish indicator to the investment
community about where the company is heading.
Continued success of the company’s already commercialized
cosmeceutical and biomedical product operations forms a key backdrop for
International Stem Cell Corporation when it comes to funding ongoing clinical
and preclinical efforts, further differentiating the company (alongside its
strong IP position) from competitors.
Take a closer look by visiting www.internationalstemcell.com
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