American regulators have recognised the potential ReNeuron’s (LON:RENE) stem cell treatment for a group of rare eye diseases by granting it fast-track status, according to the company’s chief executive Olav Hellebø.
The US Food & Drug Administration took the step of putting the firm’s human retinal progenitor cell (hRPC) therapy for retinitis pigmentosa on the fast track after reviewing pre-clinical data ahead of granting permission for phase I/II trials.
ReNeuron’s researchers will have greater interaction with the FDA during the development phase and it will receive a priority review of findings in order to get the treatment to patients as quickly as possible.
ReNeuron’s unique approach to eye disease already has orphan drug status that recognises its potential to treat rare illnesses and may also shorten the clinical trial process.
CEO Hellebø told investors: “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 RP as a serious unmet medical need.
“This, together with the orphan drug designation already granted for the programme in both the US and Europe, provides accelerated clinical development and marketing authorisation processes for our retinitis pigmentosa treatment candidate as well as the potential for a significant period of market exclusivity once approved in these major territories."
Earlier this month the FDA gave the go-ahead for the use of the AIM-listed group’s human retinal progenitor cell therapy candidate in 15 patients with retinitis pigmentosa (RP).
RP 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 phase I/II trial will be overseen by Massachusetts Eye and Ear, in Boston, a world-renowned clinical centre for the treatment of retinal diseases.
Preparations have already begun and ReNeuron said it expects the study to start in the second half of this year.