EU clears stem cell trial for broken hearts
Sep 5, 2011, 3:14 a.m.
LONDON (Reuters) - An Australian company developing a stem cell treatment to prevent heart failure has been given the go-ahead for a mid-stage clinical trial in Europe, moving potential "off-the-shelf" stem cell treatments a step closer.
Mesoblast said Monday it had won clearance from the European Medicines Agency to begin a 225-patient Phase II for its product Revascor to prevent heart failure after heart attacks. Patients will be recruited initially in Britain, the Netherlands and Belgium.
The experimental treatment is injected at the same time as patients receive a coronary stent to open blocked arteries.
Mesoblast works with adult stem cells known as mesenchymal precursor cells. Because they do not trigger an immune response, cells from one donor can be greatly expanded to treat many patients, giving Mesoblast potential therapies that could be sold like off the shelf medicines.
"The clearance for the Phase II is further evidence of the broader acceptance of stem cells within the various regulatory environments globally and of their support for larger clinical studies," said Navid Malik, an industry analyst at Matrix.
Stem cells remain a risky and uncertain proposition in medicine, but the field is attracting increasing interest from larger pharmaceutical companies.
Last December, Cephalon acquired a 20 percent stake in Mesoblast, and that holding will transfer to Teva, following the Israeli company's deal to buy Cephalon for $6.8 billion in May.
Osiris Therapeutics, meanwhile, has a long-standing partnership with Sanofi's Genzyme unit, and Athersys got a big vote of confidence when it signed a deal with Pfizer in December 2009.
Other companies working on stem cells include Britain's ReNeuron, which is testing foetal cells in stroke patients, and Geron, which is pioneering the world's first trial using embryonic stem cells in patients with spinal cord injuries.
(Reporting by Ben Hirschler; Editing by Will Waterman)
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