Opening minds: the biotech company aiming to change stroke victims’ lives
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Version 0 of 1. He wants to bore a hole in your head. But don’t panic, Olav Hellebø is not a modern-day trepanist and it will be a top-notch surgeon, not the 49-year-old Norwegian businessman, holding the drill. Drilling holes in the skull sounds drastic. But Hellebø says it is worth it; the procedure, coupled with injections of stem cells, from his British biotech company Reneuron, could help heal victims of debilitating strokes, he says. “It’s a routine thing but it does sound pretty scary to me,” Hellebø says of cranial drilling. “You only do it if you think it is going to make a significant difference to the patient. You set the bar pretty high, it’s not an antihistamine pill.” The treatment isn’t pills but millions of stem cells – undifferentiated cells that can be encouraged to grow into all kinds of human cells. Hellebø says the cells injected into patients’ brains can be encouraged to regenerate neurons lost in a stroke. “The field is regenerative medicine, which in a word tells you it is about regenerating cells which are missing or damaged in some way. So in a way it is a cure,” he said. “Reneuron is re-growing neurons in the brain. The idea is that we can somehow spur the regrowth of those neurons so we can improve the outcomes of strokes.” The treatment, first developed by John Sinden, in a King’s College London laboratory 15 years ago, has passed phase-one trials and the firm has begun phase-two clinical trials with 41 patients. Hellebø, an experienced biotech executive who previously commuted from his Hampstead home to Oslo while head of the Norwegian firm Clavis Pharma, was brought in by Reneuron’s directors this autumn to drive the firm and its technology from the lab bench into hospitals. He believes that if the procedure is successful it could give hundreds of thousands of stroke patients their lives back, and save billions for the NHS and other countries’ healthcare budgets. At present, he says, stroke patients typically improve for a few weeks, but then stop progressing. “Our plan is to treat the patient after a month, maybe two, and kickstart that healing process again,” he said. “It can have a huge impact. It can make the difference between having a full-time carer helping you with everything to being able to function by yourself.” Hellebø says he expects the treatment, which he describes as a single administration, one-shot therapy, will work on 10-15% of stroke survivors (on average there are 152,000 a year in the UK and 800,000 in the US). The injection of the Reneuron patented-stem cells called ReN001 will be expensive, to allow the company to recover the development costs dating back to its foundation in 1998. Hellebø refused to give an estimate of how much it would cost, but said it would meet strict National Institute for Health and Care Excellence (Nice) guidelines on drug cost-effectiveness, especially as the treatment could help make available some of the 25% of long-term hospital beds now occupied by stroke patients. Nice estimates that strokes cost the UK economy £7bn a year, £2.8bn of which is shouldered by the NHS. In the US it’s $70bn (£44bn). The company has struggled to live up to its promise in the past, with its share price collapsing from a high of 47p in 2007 to 2p in 2012. The shares are now worth 3.4p. But some high-profile City investors have faith in the company. Neil Woodford, who manages funds in the Woodford Investment Management company, has bought up 19.94% of Reneuron’s shares. The maximum stake his fund, allows itself to hold in any one company is 20%. Hellebø’s next tasks are to convince the NHS to buy into the idea and increase production of the cell as each injection requires 20m cells. Production will increase when the company moves from a research park in Guildford to a purpose built, partly government-funded, robotic factory in south Wales in 2015. Hellebø is keen on the £37m of Welsh government funding, but less keen on subjecting his family to the Welsh rain. “Somebody gave me a map of south Wales, but it was laminated to give me a warning about the weather.” The company has also won the backing of Westminster, with it being a big beneficiary of the government’s £30m stem cell research centre. Hellebø said that despite the small size of the company – it employs 35 people – government support is extensive. “It goes to Vince Cable, and above actually,” he said. “We have lobbied at the highest levels.” While he gets the stroke treatment to market, Hellebø’s scientists – led by Sinden as chief scientific officer – are working on the next generation of applications. In the pipeline are stem cell treatments for critical limb ischaemia, a serious and common side effect of diabetes that can lead to gangrene and 160,000 leg amputations a year in the US, and retinitis pigmentosa, a degenerative eye disease that causes severe vision impairment and often blindness. “That area [blindness] is very hot,” Hellebø said. “This is about preventing blindness and curing blindness. The idea is to treat people close to blindness, and arrest and even for some people restore some measure of sight.” He describes the disease as “like tunnel vision that gets narrower and narrower until it’s over, which is scary”. The company hopes to begin a clinical trial of retinitis pigmentosa treatment in the US next year. Like the stroke treatment it doesn’t sound too appealing. This time it’s a subretinal injection, which means “sneaking [a needle] around behind the eyeball”. “Don’t worry the patient is put under anaesthetic. I guess it’s a bit worse than putting a contact lens in, but it’s still relatively routine.” For Hellebø, who took over as chief executive in September, getting the products to a commercial launch in the next five years will be the fun bit. “This is why I joined the company. I let them do the hard work for 15 years and jumped in now, now that the company is really well positioned to have great success.” Although he has a financial incentive, having been granted 1.5% of Reneuron’s shares when he joined, he says his main motivation is to ensure the scientific promise is delivered to patients. “They [the scientists] want to see their lifetime work bear fruit, they want to see patients being helped. Imagine going from an idea in a laboratory to improving somebody’s life. “The odds on getting from the lab bench to clinical trials are very, very low, but we made it – John [Sinden] has made it – we are at clinical trials. Now, obviously, we want to go all the way and launch.” |