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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