ReNeuron reports positive results in Phase II Stroke Trial

ReNeuron Group announces positive data from its Phase II clinical trial (PISCES II) of its CTX cell therapy candidate for stroke disability.

PISCES II is a single arm, open-label study in patients living with disability resulting from ischaemic stroke.

The study’s primary endpoint was for two patients to reach a minimum two-point improvement in the grasping and lifting test, sub-test number 2, of the Action Research Arm Test (“ARAT”), at three months post-treatment.

Three of the 21 patients achieved this at three, six or twelve months respectively after treatment and were within a group of four responders who also showed clinically relevant improvements on the total ARAT score of arm motor performance.

Although the ARAT sub-test number 2 study endpoint was not met as some responses came later than the three-month target, the result is nonetheless highly encouraging.

Strongly positive results were also seen in the other endpoints of the study, with seven patients (33%) showing a clinically relevant improvement on the Modified Rankin Scale (a measure of disability and dependence) and eight patients (38%) showing a clinically relevant improvement on the Barthel Index (a measure of performance in activities of daily living).

In total, 15 out of 21 patients had a clinically significant response on at least one efficacy measure. Improvements in the ARAT scores, Modified Rankin Scale and Barthel Index were all sustained throughout the follow up period.

As a result of the positive data from the PISCES II study, the Company intends to apply to the US and European regulatory authorities to commence a randomised, placebo-controlled, pivotal clinical trial in patients who are living with disability post-stroke.

At 9:38am: (LON:RENE) ReNeuron Group PLC share price was +0.01p at 2.88p

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