Reneuron Group (LON:RQE) reported in December 2016 positive Phase II trial data for its CTX cells in chronic stroke patients, despite not meeting the three-month time frame of a two-point improvement in its primary outcome measure, the Action Research Arm Test (ARAT). As a result, the company has confirmed that it will progress to a pivotal controlled clinical study in 2017. Beyond CTX, we expect safety and efficacy data from its retinitis pigmentosa (RP) trial in 2017 and Phase I data from its critical limb ischaemia (CLI) trial. Our rNPV has increased to £291m.
Stroke Phase II data review
PISCES II was a single arm, open-label study in patients with stable paresis (partial paralysis) of an arm 4-12 weeks following an ischaemic stroke. The primary end point of a minimum two-point improvement in the ARAT was not met within the pre-specified three-month time period, although three patients met the criteria at three, six and 12 months after treatment respectively. Also, clinically relevant end points were seen in other efficacy measures, with 15/21 patients achieving a clinically relevant and sustained response on at least one measure. Importantly, CTX was shown to be well tolerated, with side effects only relating to the surgical procedure.
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