ReNeuron completes patient recruitment for phase II stroke trial

Three-month follow-up data is anticipated to be available in the fourth quarter of this year.

The company started the regulatory process for a phase II/III clinical trial for CTX in stroke disability with US Food and Drug Administration. Similar talks are also taking place with the European Medicines Agency.

Subject to the Phase II study results, ReNeuron plans to file an application in the first quarter of 2017 to start a phase II/III clinical trial.

The company has appointed a sales team in Japan after changes in regulations that allow conditional marketing approval for cell therapies at an earlier stage of clinical development than in the West.

ReNeuron plans to undertake discussions with regulatory authorities in Japan to see how CTX is affected by the new regulations.

ReNeuron CEO Olav Hellebø said: "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."

The company said CTX stem cell therapy candidate has been demonstrated to reverse the functional deficits related with stroke disability when administered several weeks following the stroke event in appropriate pre-clinical models.

Extensive pre-clinical testing also suggests that the therapy is safe, with no adverse safety effects resulting from the cells administration.