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 regards 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 which very few young biotechs can boast of.
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
