A news story out this week (http://dtn.fm/SW1v5) in the MIT Technology Review recounts the lamentable tale of a man (Jim Gass) who used to be chief legal counsel for storied electrical manufacturer Sylvania – for whom a desperate search to treat his stroke with stem cells abroad invariably led to disastrous medical tourism results. Based on a study conducted by the New England Journal of Medicine, the MIT Tech Rev article’s analysis further explains that the Gass case may have occurred in part due to Google parent company Alphabet (NASDAQ: GOOG; GOOGL), as the search engine’s paid ad returns to user queries about stem cell therapies seem partly responsible for steering people into the hands of shady clinics abroad.
I don’t know what that tells commercial investors about how midcap and microcap biotech innovators are overlooked, but it tells me everything I need to know about the future of the stem cell sector, because the next decade is primed to witness unprecedented change due to emergent technologies.
This single case with Gass, where a man sought fetal tissue injections in countries like Argentina, China and Mexico, because he did not have access to domestic treatment options, paints a bold and cautionary tale about medical tourism. But it also tells a story about market potential and the huge sums of capital seeking therapy, that is currently trapped, like a spring that is ready to bounce, charged with breakout momentum. Think about Gass: the poor guy just wanted to offset the impact of his stroke and ended up with a tumor made of someone else’s tissue in his spine. Now, the former chief legal counsel for Sylvania is no schlub mind you, so this could happen to any consumer put in a similarly desperate situation. And Gass reportedly spent over $300,000 in the aggregate seeking treatments.
Let’s face the facts. We have been dragging our feet on stem cell technologies for far too long despite the massive bluesky therapeutic potential (especially when we bring personalized medicine vectors into the equation), so in many ways we created the problem. Only in recent years has the FDA begun to change its stance, and so we are late to the game on this one. While due in part to justifiable ethical concerns, the resulting sluggishness of our biotech sector has only been exacerbated by the FDA’s foot-dragging. However, with homegrown companies like revolutionary California-based biotech developer, International Stem Cell Corp. (OTCQB: ISCO), effectively in-play as the FDA continues to loosen its grip, this cautionary tale about Gass could soon go the way of the dinosaur.
The FDA cleared ISCO’s proprietary human parthenogenetic stem cell line for investigational clinical use back in 2014, and the company subsequently made significant headway across its continuously evolving therapeutic pipeline, where two of the current major vectors are Parkinson’s disease and ischemic stroke (the most prevalent type). In fact, the company just announced the results of its 12-month pre-clinical safety and efficacy primate study of its proprietary and readily expandable ISC-hpNSC® (human parthenogenetic stem cells-derived neural stem cells) platform, as being published in the well-respected and peer-reviewed journal, Cell Transplantation.
This publication marks the end of preclinical work for ISCO’s Parkinson’s disease program and confidence is now high at the company, with clinical trial approval of ISC-hpNSC® for the treatment of Parkinson’s disease secured, and Phase 1 clinical trial enrollment underway in Australia. Patients with moderate to severe Parkinson’s are cleared by the Melbourne Health Human Research Ethics Committee and ISCO’s groundbreaking study is being conducted at the Royal Melbourne Hospital in Australia. Great news, especially when one considers the results of a new landmark Mayo Clinic study (http://dtn.fm/3E6wT) published in JAMA Neurology, which shows a big uptick in Parkinson’s rates from 1976 to 2005, a trend whose forward projections look brutal, even in a best case scenario.
Given the extant evidence thus far showing that ISC-hpNSC improved Parkinson’s disease symptoms markedly in subjects, where dopaminergic neuron mass increased significantly, even as dopamine concentrations rose amid clear neurotrophic support from the therapy – the potential for the company’s neural stem cells in stroke demands a second look as well. It should come as no shock, even to lay investors, that the same kind of injectable ISC-hpNSC therapy able to address Parkinson’s disease can be used to also treat stroke. However, the actual data the company has put together to date on the efficacy of such treatment paints a far more compelling picture.
Being that the standard of care currently involves attempting to dissolve the blood clot within the first few hours after the initial event, followed up by only marginally effective and often extremely challenging rehabilitation work aimed at returning as much cognitive and functional capacity as possible to the patient – the advent of an actual stem cell-based therapy could change the stroke market completely. The National Stroke Association indicates that stroke is the fifth leading cause of death in America and that it is a leading cause of adult disability, alongside other neurological diseases/disorders such as Parkinson’s. According to a new Persistence Market Research report, North America continues to be the largest market by far for stroke diagnostics and therapeutics, with Asia set to experience high levels of growth in the next few years. This outlook jogs well with Transparency Market Research’s most recent publication on the sector, which projects a market worth $1.9 billion by 2020, growing at a CAGR of around 6.3 percent.
Pre-clinical data suggests that ISCO’s neural stem cell therapy approach not only addresses but can actually reverse the functional deficits associated with a stroke. What’s more, rather than needing to be applied within hours, the therapeutic benefits from such neural stem cell therapy can be accessed days, or even weeks after the stroke has occurred.
The advent of ISCO’s neural stem cell therapy would be a complete and total paradigm shift in the healthcare market when it comes to treating stroke, and the company is right here in our own backyard. Throw away your medical tourism passport America, and double down on ISCO.
For more information, visit www.internationalstemcell.com