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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