More positive news19 Jun 2017 08:36
Regulatory News
FDA approves cryopreserved hRPC formulation
Mon, 19th Jun 2017 07:00
RNS Number : 4005I
ReNeuron Group plc
19 June 2017
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AIM: RENE
19 June 2017
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ReNeuron Group plc
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FDA approves cryopreserved formulation of ReNeuron's retinal stem cell therapy candidate
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New formulation enables expansion of Company's ophthalmology programmes
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ReNeuron Group plc (the "Company") (AIM: RENE), a UK-based global leader in the development of cell-based therapeutics, provides an update on its cell therapy development programmes targeting degenerative diseases of the retina.
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We are delighted to report that the FDA has approved the cryopreserved formulation of our human retinal progenitor cell (hRPC) therapeutic candidate and that we have now started treating patients with this formulation in our ongoing US Phase I/II study clinical trial in retinitis pigmentosa (RP) patients.�
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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.�
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The new hRPC formulation has also facilitated an expansion of ReNeuron's clinical programmes in ophthalmology.� As previously announced, we 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.� We 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.
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Olav Helleb�, Chief Executive Officer of ReNeuron, said:
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"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."