LONDON (Reuters) - The first stroke patient treated with Biocompatibles International Plc's BII.L experimental stem cell therapy has shown no side effects following surgery, the company said on Tuesday, sending its shares up 10 percent.
The 49-year-old man is the first of 20 people to be treated in the Phase I/II Trial aimed at showing the therapy is safe for men and women who have had severe strokes, Biocompatibles Chief Executive Crispin Simon told Reuters.
He stressed in a telephone interview these were not results from the trial but only an instance of one patient who had done well.
“What we are looking for is to see if this treatment is well tolerated,” Simon said in a telephone interview. “This is not a scientific announcement.”
While the man regained an ability to speak and his paralysis disappeared following treatment, Simon added it was not clear whether this was due to the experimental treatment involving adult stem cells from a healthy donor.
This is because in addition to the new treatment the man also had surgery to reduce pressure on his brain, a routine operation for severe stroke patients which leads to a similar recovery in about 10 to 20 percent of cases.
“This is not result of the trial,” Simon said.
Researchers have long been looking for ways to repair the brain damage from stroke, which can cause permanent disability. Studies have shown that transplanting brain cells produced from human embryonic stem cells have helped fix such damage in the brains of rats.
In this case, researchers used a type of adult stem cells obtained from a healthy donor which the team has programmed to deliver a naturally occurring protein called GLP-1, known to protect against the cell death in the brain following stroke.
If the safety trial meets its goal, Simon said the company hopes to have a larger, randomized trial underway in 2010 with potential regulatory approval coming as early as 2012.
Biocompatibles shares were up 10 percent, or 12 pence, at 130p.
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