FDA approves cryopreserved formulation of ReNeuron’s candidate
Posted: 27 June 2017 | Niamh Marriott (European Pharmaceutical Review) | No comments yet
The FDA has approved the cryopreserved formulation of ReNeuron’s human retinal progenitor cell (hRPC) therapeutic candidate…
The FDA has approved the cryopreserved formulation of ReNeuron’s human retinal progenitor cell (hRPC) therapeutic candidate and have started treating patients with this formulation in their ongoing US Phase I/II study clinical trial in retinitis pigmentosa (RP) patients.
The new proprietary formulation enables the hRP cells to be frozen for shipping and storage and easily thawed at the point of clinical use. This freeze-thaw modality provides a greatly enhanced shelf life for the product, lower prospective cost of goods and the capability to ship the cells for clinical and commercial application anywhere in the world.
The new hRPC formulation has also facilitated an expansion of ReNeuron’s clinical programmes in ophthalmology. As previously announced, they will shortly file an application with the FDA to expand the Phase II element of the ongoing Phase I/II clinical trial in RP from six to 20 patients. The expanded study is designed to provide the depth and quality of data that, if positive, will allow subsequent progression to a Phase II/III pivotal study in this indication. They also intend to file an application to start a new US Phase II clinical trial later this year in patients with cone-rod dystrophy, to be conducted alongside the Phase II part of the ongoing RP clinical trial.
Olav Hellebø, Chief Executive Officer of ReNeuron, said:
“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 programmes. This is a further significant milestone for ReNeuron, enabling an expansion of our clinical programmes 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.”
Related topics
Cold Chain Supply, Drug Delivery Systems, Drug Manufacturing, Drug Supply Chain, Environmental Monitoring, Formulation, Freeze Drying, Good Distribution Practice (GDP), QA/QC, Quality by Design (QbD)
