The Telegraph – ReNeuron is pressing ahead with final clinical trials for an experimental stem-cell treatment that could help stroke patients after encouraging results from an earlier study.
The company, which is backed by top fund manager Neil Woodford, is developing stem cell therapies for a range of diseases. Its most advanced therapy, CTX, is designed to help stroke patients rehabilitate by injecting 20 million stem cells into the brain to repair damage and help the body regain mobility.
“It is ground-breaking because for patients who have a stroke there is currently no treatment or medical intervention available after the first few hours,” said ReNeuron’s Norwegian chief executive Olav Hellebø.
The positive result from the phase-two trial means that ReNeuron can start work with US regulators to design final phase-three trials, due to begin at the end of next year. If successful, it can then file for approval, although this will be some years away.
ReNeuron has spent the past two decades developing stem cells which, when injected into the brain close to an area where a patient suffered a stroke, create new neurons and blood vessels. It now has the ability to clone these stem cells with relative ease.
“Overnight success takes a long time,” said Mr Hellebø.
ReNeuron, which relocated its headquarters to Wales in February, has huge backing from veteran fund manager Neil Wodford. His firm, Woodford Investment Management, owns 36.16% of the Aim-listed company’s shares.
“Woodford has been a backer for the last couple of years, and it is really helpful for us to have his support as it helps get other investors interested,” said Mr Hellebø.
In January, ReNeuron was awarded a £2.1m ($2.7m) grant from Innovate UK. It also has support from the Welsh government, which offered ReNeuron several incentives to relocate to Pencoed, near Cardiff. The Wales Life Sciences Investment Fund owns 9.48% of the company.
“I’m used to regions with mountains and useless languages,” said Norway-born Mr Hellebø. “The Welsh Government wants to create a science hub.”
Having completed a large fundraising last year, ReNeuron has enough cash to bankroll phase-three trials and continue to develop a second product, which uses stem cells to treat blindness.
At the end of its half-year in September, the company had £60m ($76m) of cash in the bank.
“The eye disease product is at an earlier stage but might overtake stroke as it's an orphan indication so might move more quickly. Either way these are two solid legs for us to stand on," said Mr Hellebø.
In an ideal world, Mr Hellebø would like to develop, launch and commercialise the products in-house, but concedes this might not happen.
“Our plan is world domination and my background is in building sales forces around these products and launching them.
"That is plan A. But what happens in biotech is that plan A is sometimes taken away from you as someone gives you an offer you can’t walk away from. Either way, there will be lots of opportunities in terms of funding and partnerships.”
ReNeuron made an £8.64m ($11m) loss in the six months to the end of September, from a £5.24m ($6.67m) loss a year earlier.
“Biotech is not about making a profit, it is about coming up with ground-breaking technology that will make enormous change,” said Mr Hellebø .
Apart from the US and Europe, Japan will be a key country for ReNeuron when it comes to launching its stroke product.
The Japanese government has made it easier to launch stem-cell therapies for stroke because of a high prevalence of the illness in the country.
“There is more clinical need than in the west because they have too much salt in their diets with soy sauce and sushi,” said Mr Hellebø.
Shares in ReNeuron were up 4.35% in morning trading.