13th Jun 2016 07:58
LONDON (Alliance News) - ReNeuron Group PLC on Monday said it has completed patient recruitment in the Phase II clinical trial for patients with motor disability resulting from an ischaemic stroke.
The cell-based therapeutics developer said the Phase II clinical trial, or the PISCES II, will test its CTX cell therapy on the stroke patients. The three-month follow-up data from the study is expected to be available in the fourth quarter of 2016, ReNeuron said.
ReNeuron said it has started formal talks with regulatory authorities regarding plans for a randomised, controlled, Phase II/II clinical trial for the CTX therapy. This has included a face-to-face meeting with the US Food & Drug Administration to discuss plans for conducting a study in the US, ReNeuron said, and it is incorporating advice given at the meeting by the FDA into the design and planning of the study.
Similar discussions are taking place with the equivalent European regulatory body the European Medicines Agency, ReNeuron said, adding that it expects to file an application in the first quarter of 2017 to commence a Phase II/III clinical trial.
"The completion of patient recruitment in the PISCES II study in stroke disability marks another important step in the clinical development of our CTX cell therapy candidate for this condition. We are making good progress in planning the Phase II/III study, which we expect to be an international controlled study with patient recruitment in both Europe and the US," said Chief Executive Olav Hellebo.
Shares in ReNeuron were down 0.6% at 3.48 pence on Monday.
By Hannah Boland; [email protected]; @Hannaheboland
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