LONDON (Alliance News) - ReNeuron Group PLC Friday said the US Food and Drug Administration has given a Fast Track designation to the company's human retinal progentiro cell therapy candidate for the treatment of retinitis pigmentosa.
Retinitis pigmentosa is a group of hereditary diseases of the eye that lead to progressive loss of sight due to cells in the retina becoming damaged and eventually dying.
The fast track status grant comes after ReNeuron earlier this month said it has received regulatory approval in the US for a phase 1/2 clinical trial in the US for its stem cell therapy candidate for retinitis pigmentosa.
"The granting of Fast Track designation from the FDA for our hRPC stem cell therapy candidate for retinitis pigmentosa is a very significant positive development for the company. In considering the pre-clinical data we have presented to them and granting the designation, the FDA has recognised the potential of this treatment candidate to address retinitis pigmentosa as a serious unmet medical need," said Chief Executive Olav Hellebø.
By Sam Unsted; samunsted@alliancenews.com; @SamUAtAlliance
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Reneuron (RENE)