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Pace of progress quickens at ReNeuron as it gets set to launch two clinical trials

Stem cell research group ReNeuron will step up activity after receiving regulatory approval for two clinical trials.


Stem cell research group ReNeuron (LON:RENE) will step up activity after receiving regulatory approval for two clinical trials.

The first is a phase II study building on its early work with victims of stroke, who will receive its ReN001 investigational therapy.

Hospital trusts involved will recruit 41 patients, treating them eight to 12 weeks post-stroke, which is regarded as the “optimum treatment window” for efficacy.

The second is a phase I investigation into critical limb ischaemia. This is an ailment that results from a marked reduction in blood to the legs, feet or hands and is normally associated with atherosclerosis (furring of the arteries). In all, nine patients will be treated with ReN009.

Both trials will use CTXcryo, the cryopreserved variant of ReNeuron's CTX cell line, which provides the drug product for both the stroke and critical limb ischaemia programmes.

The formulation is cheaper, easier to use and can be stored for longer than its predecessor.

ReNeuron said early adoption of CTXcryo avoids the “likely need for subsequent, time-consuming bridging studies, thereby accelerating time to market".

Chief executive Michael Hunt said: "We are delighted to have received these concurrent clinical trial approvals for our stroke and critical limb ischaemia programmes.

“It is especially pleasing to have been given approval to use our second-generation CTXcryo cells in both of these new clinical trials.

“The fact that this new product variant is being deployed clinically much earlier than we had planned is illustrative of ReNeuron's ability, in collaboration with its various partners, to successfully innovate and sustain its commercial and competitive edge."

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