International Stem Cell Corp. is a
biotech company with key stem cell technologies under their belt and a clear
focus on therapeutic and clinical product development. The company has a slew
of long-term therapeutic opportunities on the table, as well as two important,
revenue-generating subsidiaries already running which could become even more
significant revenue engines as the company’s development pipeline progresses
further. The company’s human parthenogenetic stem cell (hpSC) technology has
several advantages compared to other stem cell technologies in existence today,
like embryonic, induced pluripotent, or adult stem cells, with equivalency to
embryonic stem cells when it comes to generic diseases and superior immune
matching to all three. And unlike induced pluripotent stem cells for instance,
hpSCs have not been genetically reprogrammed or manipulated by viruses, giving
them vastly superior long term viability as a treatment vector.
ISCO’s unique, ethical techniques of
chemically stimulating (parthenogenesis) unfertilized female gametocytes (egg
cells), known as oocytes, means that no viable embryo has been created or
destroyed in the process of creating their hsPCs. Furthermore, specific
differences in activation techniques can yield either HLA (human leukocyte
antigen) heterozygous or HLA homozygous hpSCs, which are histocompatible with
the donor, or with large segments of the human population respectively. The
combined benefits from being immunomatched and the ethical nature in which
their hsPCs are produced, sets the ISCO stem cell technology apart from the
competition when it comes to developing truly 21st century cell-based
therapies.
These key advantages have allowed
ISCO to rapidly develop brain, liver and corneal (eye) cells to treat Parkinson’s
disease (and potentially other neurological disorders), the effects from
various causes of liver damage, and also address the millions of people
worldwide who need corneal transplants each year, due to various eye diseases
or injuries. International Stem Cell has already seen some incredible R&D
milestones, well beyond their core small molecule-based differentiation methods
used to produce large batches of extremely pure cells in a controlled manner,
which has allowed the company to seriously address a host of clinical stem cell
usage requirements, unlike many of the company’s competitors who are unable to
produce high quality stem cells in large quantities. From ISCO’s creation of
dopaminergic neurons for the treatment of Parkinson’s, whose ability to engraft
and produce dopamine (as well as to produce brain-protecting neurotrophic
factors) has been successfully shown in animal model studies, to the creation
of human hepatocyte-like cells that have been shown in animal models to
engraft, mature and express key human liver proteins, the company has seen
their hsPCs quickly transform the concept of what is possible in stem cell
therapies today. The creation of self-assembling human corneas, including all
the requisite cell layers needed to make the product ideal for transplants or
drug toxicology testing, perhaps shows best just how powerful ISCO’s technology
really is and what lies in store for future developments.
ISCO’s high capacity production
techniques have made it possible for the company to create the UniStemCell
bank, which is the life science industry’s first real stem cell bank of
non-embryonic and histocompatible human stem cells, making possible both
commercial use and extensive research work. The company’s master stem cell bank
carries fifteen key hpSC lines, one of which has the most common immune type
(haplotype) and is immune-matched to some 70 million people on earth. In
February of this year, International Stem Cell completed manufacturing all the
clinical-grade hpNSCs (human parthenogenetic neural stem cells) required using
their patented process which are needed for their upcoming Phase 1/2a clinical
trial in Parkinson’s disease in Australia, which will be conducted via their
localized Cyto Therapeutics Pty Ltd. subsidiary. This trial will not only
further document the efficacy of the company’s stem cell technology, it will
form the basis for regulatory submission to the Australian Therapeutics Goods
Administration (TGA) and for further clinical hpNSC studies in Parkinson’s in
the United States.
Already covered in pre-IND meetings
with the FDA, the company’s master cell bank of hpNSCs are produced with full
cGMP compliance and relevant chemistry and manufacturing controls, and the
parthenogenetic line derived undifferentiated cells has already been cleared by
the FDA for use in clinical trialing. Given that the company has produced and
cryopreserved enough material at their state-of-the-art, GMP-compliant facility
in Oceanside (CA), required to serve all anticipated needs through their clinical
trials (in conjunction with their current production-scale capabilities),
management is confident that the company will see great success with their
Phase 1/2a and subsequent Phase 2b/3 trials.
With considerable and growing
revenues from their B2B Lifeline Cell Technology operations, which provide
various purified primary human cells and optimized reagents for cell culture to
numerous industry operators, as well as from their Lifeline Skin Care®
operations, which develops and markets anti-aging skin care solutions based on
hpSC derived growth factors and peptides, ISCO has the kind of clinical
development capital backstopping most other developers lack. However, as with
all such clinical development work, the overall costs to implement all related
business, operating and development plans can be enormous. The deal with
Lincoln Park Capital Fund, LLC to sell up to $10.25 million of common stock has
helped to support operations, with a $1.588 million raise (8.2M shares) during
the nine months ended September 30, 2014 (subsequent private placement
agreements with Lincoln Park means the company won’t be selling any more shares
to Lincoln Park until March 2016). Q3 2014 also saw insider skin in the game
increase, with some 10.4 million shares sold to the CEO and Board Co-Chair Dr.
Andrey Semechkin, and Dr. Ruslan Semechkin, as well as the CSO and a company
Director, which brought in an aggregate $1 million.
Over a million people in the U.S.
alone live with Parkinson’s and incident rates are set to continue rising as an
ageing population stimulates a roughly 4% CAGR according to a recent report
published by GlobalData. The treatment market for Parkinson’s alone is on track
to hit $5.3 billion by 2022 and ISCO is one of the clear front runners in the
game today with a therapeutic option emerging that has the potential to even
reverse the effects, but it will take investors who understand the longer-term
upside to help further support the company’s clinical development initiatives.
Take a closer look at the company by
visiting www.internationalstemcell.com
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