ReNeuron Group plc announced it has received approval from the U.S. FDA for the cryopreserved formulation of its human retinal progenitor cell (hRPC) therapeutic candidate, and the company has now started treating patients with this formulation in its ongoing US Phase I/II study clinical trial in retinitis pigmentosa (RP) patients.
According to ReNeuron, the new proprietary formulation enables the hRP cells to be frozen for shipping and storage, and easily thawed at the point of clinical use. The freeze-thaw modality also reportedly gives the product an enhanced shelf life and the capability to ship the cells for clinical and commercial use anywhere in the world.
Additionally, the new hRPC formulation has reportedly facilitated an expansion of ReNeuron's clinical ophthalmology program. The company reportedly plans to file an application with the FDA to expand the Phase II element of its ongoing Phase I/II clinical trial in RP from six to 20 patients, and also intends to file an application to start a new U.S. Phase II clinical trial later this year in patients with cone-rod dystrophy.
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Source: ReNeuron Group plc