ReNeuron Group Plc (RENE) Chief Executive Officer Michael Hunt said he expects researchers to report that people disabled by strokes showed progress and weren’t harmed in an early-stage test of the company’s stem-cell treatment.
Doctors conducting the trial at Southern General Hospital in Glasgow, Scotland, plan to present the “encouraging data” from the first nine patients studied at a conference in London this month, Hunt said at an investors’ meeting yesterday. The patients showed improvement on several measures in the first year, Hunt said.
“We see sustained reductions in neurological impairment and modified spasticity in most patients,” Hunt said. “There’s a nice trend downward over time. It sets us up nicely for a Phase 2 efficacy trial.”
ReNeuron began the safety trial more than two years ago after obtaining permission from U.K. regulators. There aren’t any treatments to reverse the disability caused by strokes, which occur when there is a sudden loss of blood to the brain. Every year, about 5 million people worldwide are disabled by strokes, according to the World Health Organization in Geneva.
ReNeuron closed down 0.4 percent at 2.69 pence in London, giving the company a market value of 20.8 million pounds ($32 million). Shares of the Guildford, England-based company have climbed 35 percent this year.
The trial was designed to primarily test the safety of the ReN001 experimental treatment, as well as its effects on motor and cognitive functions. The patients had holes drilled in their skulls and millions of stem cells injected into their brains through a needle. The cells are from a line grown from a tissue sample taken in 2003 from the brain of an aborted fetus. None of the patients suffered adverse events, other than one or two patients who had “minor post-surgical bleeds,” Hunt said.
“Until we get a Phase 2, we have to treat these data carefully,” Hunt said.
More detailed data is expected from the study team at the European Stroke Conference in London on May 28-31, he said.
The researchers are continuing to monitor the first nine patients as well as two additional people treated more recently and will update the data accordingly, Hunt said. ReNeuron plans to begin a mid-stage stroke trial in the third quarter, he said.
The company is also preparing to do a Phase 1 trial this summer of another stem-cell therapy, ReN009, in critical limb ischemia, a condition that can lead to amputation, he said. ReNeuron has already received regulatory and ethics board approval for the study.
ReNeuron also plans to begin an early-stage test of a third stem-cell treatment, ReN003, for the eye disease retinitis pigmentosa in the U.S. in 2014, Hunt said. It has had initial discussions with the Food and Drug Administration and has collaborated with researchers at the Schepens Eye Institute at Harvard Medical School, the University of California San Diego and University College London, he said.
“We’d probably start there in the U.S., maybe extend it to the U.K. later,” Hunt said.
Hunt said the company is preparing to raise more money before it runs out of cash later this year. It has obtained about 2.5 million pounds of grants and has other applications pending, he said.
“We’ve got enough to get us to the back end of the year,” Hunt said. “We’ll have to raise money in relatively short order.”
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