Stroke is the fourth largest cause of death in the UK after cancer, heart and respiratory disease, killing 50,000 people in 2010 – and rates are rising as the population ages. Treating stroke patients costs more than £5 billion a year and current treatments are limited to relieving symptoms and preventing further deterioration.
But an innovative treatment developed British cell therapy company ReNeuron with grant funding and support fromInnovate UK and the Cell Therapy Catapult, could revolutionise treatment of strokes in the UK, not only improving the outcome for patients but also saving millions of pounds.
The stem-cell based treatment (known as ReN001) regenerates healthy cells inside the patient to replace stroke-damaged ones, reducing levels of post stroke impairment.
It’s currently in a Phase II clinical trial in hospitals across the UK, having recently completed a Phase I clinical trial in disabled stroke patients that produced encouraging results.
Pre clinical trials showed that ReN001 stimulated natural repair mechanisms in organs. For example, it led to the generating new brain cells, leading to repairs in the brain and reductions in the functional impairments associated with strokes.
Operating in a big but relatively poorly-researched field, ReNeuron is focusing trials on a group of stroke survivors with a poor prognosis for further spontaneous recovery of motor function.
“Stroke treatment needs a novel approach. We had very convincing pre-clinical data that we and our academic collaborators have replicated and published.
“We’re targeting an unmet medical need that could also be a multi-billion dollar global market opportunity. Our analysis suggests we have a treatment that could possibly be worth at least $1-2 billion a year in the US, and there’s very little direct competition in this area,” said Michael Hunt CEO of ReNeuron.
The company’s analysis indicates that if hoped-for levels of benefit in reducing patients’ disability can be achieved it should also be highly cost effective.
ReNeuron manufactures cells that can be administered to any patient. The ReN001 treatment for stroke involves direct injection of cells into the patients’ brain.
The cells have the ability to restore blood flow, by a process known as angiogenesis, the ability to generate new brain cells, via a process called neurogenesis and they can also modulate the immune system to prevent further damage.
“We’re still working out what the cells can do as we develop the technologies – what they secrete, what they signal to neighbouring cells for beneficial effect, and so on,” said Michael.
For example, nanoparticles called exosomes are thought to be responsible for cell-to-cell signalling. ReNeuron’s own exosome platform is being developed for therapeutic use, targeting a range of further disease conditions beyond those targeted by its cell therapies.
Michael believes that regenerative medicine is very susceptible to the “valley of death” development gap scenario, due to its youth and the development risks associated with it.
“Venture capital investors aren’t investing in this field in the UK and many City investors are also cautious about investing or are looking for impossibly quick returns,’ he commented.
However, a series of Innovate UK grants and the Catapult’s endorsement of ReNeuron’s work has helped secure private sector investment – indeed some grants require match-funding to be activated.
“Those small grants were instrumental in giving us credibility to raise far larger sums in the general equity market,” said Michael.
Including Innovate UK grant funding and direct funding from the Welsh Government, the company raised over £37 million in public and private funding during 2013 – to finance the development of stem cell therapies for stroke, limb ischaemia and retinitis pigmentosa and construct a new cell manufacturing, research and corporate office facility outside Cardiff.
As one of the longest-established players in the field of regenerative medicine, CEO Michael Hunt was on the implementation group that originated the Cell Therapy Catapult and is a big advocate for it and for Innovate UK.
“We know we’re dealing with people who understand what we were trying to achieve, who speak our language. Innovate UK and the Catapult play a pivotal role in building a flourishing regenerative medicine sector in the UK,” he commented.
ReNeuron strongly advocates the power of collaboration, to leverage the expertise of the relatively small pool of experts in this new field and ensure future success both for the company and for the UK.
“Finding good people to collaborate with isn’t straightforward, but being involved with the Cell Therapy Catapult means we can tap into expertise that gives us a ‘leg up’ on several of our programmes; for example accessing experts who helped us optimise scaling-up cell manufacture,” Michael added.
ReNeuron believes there’s a strong rationale for funding sectors delivering innovations that answer some of the pressing issues facing the UK as a society.
“It makes sense to focus funding for innovation in areas where the government faces challenges like the impact of changing demographics and ageing populations on healthcare. The numbers are scary, but therapies like the ones we are developing could make a big difference not only in terms of better outcomes for patients, but by reducing costs,” he explained.
“ReNeuron’s journey illustrates clearly how Innovate UK and Catapults help companies bridge the development gap. We help them research and develop innovative solutions, secure funding, collaborate and network with experts in the field and bring commercially viable products to market. It can be a long-haul but the potential benefits, not just for the companies but also for UKplc are immense,” Keith Thompson, CEO Cell Therapy Catapult
Founded in 1997, ReNeuron is one of the longest established companies in Britain’s regenerative medicine industry. The Guildford-based company has 30 employees.
In the last 18 months it has raised £37 million in private equity and grant funding, started a Phase II clinical trial of its key stroke patient treatment ReN001, and initiated a project to build a new manufacturing and research facility in South Wales.