ReNeuron Group plc - Regulatory Approvals and Programme Update
ReNeuron Group plc
Regulatory approvals and programme update
The Company is pleased to announce that it has received regulatory approval from both the FDA and MHRA for the expanded Phase 2a study in RP patients. The Company expects to commence treating patients shortly in both the US and the
Following a review of programme priorities and resource requirements, the Company's existing resources will be refocused on programmes and activities offering the greatest prospect of value generation in the near to medium term. The Company therefore intends to focus its resources on its retinal disease programme and its exosome and induced pluripotent stem cell (iPSC) research platforms.
The Company has previously announced commercial collaborations to explore the potential of its exosomes to deliver therapeutic agents to the brain. Further collaborations with pharmaceutical/biotech companies are anticipated to commence over the coming months.
The Company's induced pluripotent stem cell (iPSC) platform enables the derivation of an unlimited variety of different stem cell populations that can be utilised as new cell-based therapeutic candidates or for the production of exosomes with specific tissue targeting, thus providing further scope for a wide range of industry partnerships.
The Company's stroke disability programme with its CTX cell therapy candidate will continue through regional partnerships.
The Company's CTX cell therapy candidate will be made available for licensing in stroke disability outside
The CTX cell therapy candidate will also be available for licensing in other indications such as Huntington's disease, a progressive genetic brain disorder where recently published non-clinical data has demonstrated the potential of CTX cells to address the deficits associated with the disease. The data, published in the journal Stem Cells, are viewable at the following link: https://stemcellsjournals.onlinelibrary.wiley.com/doi/10.1002/stem.3191
Further details of the Company's exosome and iPSC programmes will be provided in the Company's preliminary results for the year ended
"We are delighted to have received regulatory approvals in both the US and the
"Focusing our in-house activities on our retinal disease and exosome-based programmes provides the Company with significant near-term opportunities to deliver value-enhancing data and commercial partnerships."
This announcement contains inside information. The person responsible for arranging for the release of this announcement on behalf of the Company is Olav Hellebø, Chief Executive Officer.
+44 (0) 20 3819 8400
Olav Hellebø, Chief Executive Officer
Michael Hunt, Chief Financial Officer
Buchanan (UK Media/Investor Relations)
+44 (0) 20 7466 5000
Mark Court, Tilly Abraham
Claudia Styslinger, David Rosen
+1 212 600 1902
Jonathan Senior, Stewart Wallace, Ben Maddison
+44 (0) 20 7710 7600
N+1 Singer (Joint Broker)
Aubrey Powell, James Moat, Tom Salvesen
+44 (0) 20 7496 3000
ReNeuron is a global leader in cell-based therapeutics, harnessing its unique stem cell technologies to develop 'off the shelf' stem cell treatments, without the need for immunosuppressive drugs. The Company's clinical-stage candidates are in development for the blindness-causing disease, retinitis pigmentosa, and for disability as a result of stroke. ReNeuron is also advancing its proprietary exosome technology platform as a potential delivery system for drugs that would otherwise be unable to reach their site of action. ReNeuron's shares are traded on the London AIM market under the symbol RENE.L. For further information visit www.reneuron.com.
This information is provided by RNS, the news service of the
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