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ReNeuron update outlines ambitious plans for stroke and ophthalmology programmes

The company said it is preparing to meet with US regulators on plans for a phase III trial of its treatment for victims of stroke, while it wants to expand its ophthalmology study
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Major step forward: The new formulation of its human retinal progenitor cell extends the therapy's shelf life

Shares in the stem cell specialist ReNeuron Group Plc (LON:RENE) rose 3% after it provided positive updates on two clinical programmes that also gave a roadmap for their progress.

The company said it is preparing to meet with US regulators on plans for a phase III trial of its treatment for victims of stroke, while it wants to expand its ophthalmology study.

The stroke programme first: ReNeuron said it will conduct an end of phase II meeting with America’s Food & Drug Administration later this month at which it will seek guidance ahead of submitting plans for a phase III study.

Subject to feedback, it expects to file its investigational new drug application later this quarter with the study slated to get underway in the second-half.

WATCH: ReNueron CFO "pleased" with degenerative treatment reformulation

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ReNeuron has also held talks with the European Medicines Agency and will file an application with them for a phase III trial shortly after it has done so with the FDA.

Finally in Japan, meetings with the regulatory authorities are ongoing that might see its CTX cell therapy receive early marketing approval.

The above discussions followed the positive results generated from its PISCES II study of stroke patients.

New formulation a major step forward...

In a separate announcement, ReNeuron said a new formulation of its human retinal progenitor cell (hRPC), being trialled to treat degenerative diseases of the retina, represents a “major step forward”.

New formulation a major step forward...

It is now able to cryopreserve (freeze) its updated hRPC, extending its shelf life and allowing it to be shipped anywhere around the globe.   

The company is asking the FDA whether the modified treatment can be used in the third and final dosing groups for the phase I stage of a phase I/II trial being conducted at the at Massachusetts Eye and Ear Infirmary in Boston.

It also hopes to expand the phase II element of the study using the updated hRPC to 20 patients from six.

Finally, ReNeuron said it had decided to put its programme for critical limb ischaemia on hold for the time being in order to focus its attention on its programmes for stroke and degenerative eye disease.

At 2.40pm, the shares were changing hands for 2.17p each. The City broker N+1 Singer believes they are worth 9p each.

Off-the-shelf therapies

ReNeuron’s stem cell technologies are being developed as potential off-the-shelf therapies to treat diseases with no approved or adequate treatment options, says N+1  

“We believe off-the-shelf therapies offer practical and cost advantages over using the patient’s own stem cells,” said analyst Sheena Berry.

Its CTX line has been generated using ReNeuron’s cell expansion and cell selection technology and then taken through a full manufacturing scale-up and quality-testing process.

Because it is derived from a single donor, there should be complete consistency between cell banks and no risk of the variability the can occur when multiple donors are needed for cell supply.

Its human retinal progenitor cells (hRPC) are derived from technology in-licensed from the Schepens Eye Research Institute at Harvard Medical School. It is being developed as a potential treatment for retinitis pigmentosa.

Stroke opportunity

Stroke is the fifth-largest killer in the US, with 800,000 victims annually; here in the UK the toll is around 150,000. According to the City research outfit Edison, the direct costs in the US alone are £26bn, with a similar amount spent on care and treatment in Europe.

 

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