The cryopreserved formulation of a therapeutic candidate for retinitis pigmentosa (RP), based on human retinal progenitor cell (hRPC), has been approved by the FDA. This approval clears the way to its manufacturer, ReNeuron Group plc (London, UK), to start treating patients in its ongoing Phase I/II trial with this new formulation.
Olav Hellebø, Chief Executive Officer, ReNeuron, commented: "We are delighted that the FDA has approved the use of the cryopreserved formulation of our hRPC retinal cell therapy candidate in our ongoing clinical development programs.
“This is a further significant milestone for ReNeuron, enabling an expansion of our clinical programs in ophthalmology as well as providing ReNeuron with a significant commercial advantage in terms of prospective cost of goods and ease of use of a retinal disease therapy."
Utilizing cryopreservation allows for easier shipping and storage of the therapy, offering improved shelf life, potentially lower cost and the ability to ship the cells worldwide. This approval will also allow ReNeuron to expand its ophthalmology program; it plans to soon apply to increase its Phase I/II trial on RP from six to 20 patients with a view to progress to a Phase II/III on delivery of positive data. It’s also planning a new Phase II trial in the US looking at cone-rod dystrophy.