Cryopreserved formulation of retinal stem therapy candidate approved by FDA

Cryopreservation will enable easier shipping and storage, allowing the retinitis pigmentosa therapeutic candidate to be used around the world.

Go to the profile of Freya Leask
Jun 22, 2017
0
0
Upvote 0 Comment

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.

Source: http://www.reneuron.com/news-list/fda-approves-cryopreserved-formulation-of-reneurons-retinal-stem-cell-therapy-candidate/

Go to the profile of Freya Leask

Freya Leask

Editor and Community Manager, Future Science Group

I am the Editor and Community Manager of the RegMedNet and 3DMedNet communities, here to help users make the most of the website. I am passionate about digital and STM publishing, as well as regenerative medicine and medical 3D printing. Please get in touch if you have any queries or comments!
61 Contributions
27 Followers
12 Following

Please sign in or register for FREE to comment