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 Conditional approval, if granted, would allow Cardiff-based Cell
Therapy to start selling its Heartcel product for regenerating
damaged areas of heart while continuing to collect further clinical
evidence about its effectiveness.
The European Medicines Agency (EMA) is keen to test such conditional
approval procedures as part of a drive to evaluate promising
life-saving treatments more swiftly than in the past.
Cell Therapy believes its medicine has the potential to reduce
scarring of the heart muscle caused by a heart attack or heart
failure.
Filing with the EMA is planned for mid-2016 and, if successful,
approval could be granted as early as 2017, the company said on
Monday.
The potential speedy path to market increases options for the
business, whose founder Martin Evans shared the 2007 Nobel Prize for
medicine for groundbreaking stem cell research, including a possible
stock market flotation.
So far, Heartcel has only been tested on a small number of patients.
However, all 11 patients with heart failure in a mid-stage Phase II
trial were still alive after an average of 28.4 months, against an
expected annual mortality rate for such individuals of up to 70
percent.
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In February, Cell Therapy was in the news after raising 691,000
pounds ($1.05 million) via crowdfunding, using the website Crowdcube.
(Reporting by Ben Hirschler)
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