First patient dosed in latest ReNeuron study of CTX cell therapy

Cell-based therapeutics developer ReNeuron Group announced on Thursday that the first patient has been treated in the US Phase IIb clinical study of its ‘CTX’ cell therapy candidate for stroke disability.

The AIM-traded firm said the study, designated PISCES III, was a “randomised, placebo-controlled clinical trial” involving 110 patients across 40 clinical trial sites in the US.

Patients with stable post-stroke disability were entered into the study six to 12 months after their stroke, and were randomised to receive either the CTX therapy or placebo treatment.

The board said the primary end-point of the study was a comparison of the proportion of patients in the treated and placebo arms, showing a “clinically significant” improvement on the Modified Rankin Scale, which is a measure of disability and dependence, at six months post-treatment compared with baseline.

Top-line results from the study were expected in early 2020.

“At McGovern Medical School at UTHealth, we have been studying cellular therapies as a novel treatment for stroke over the past 10 years,” said Sean I. Savitz, professor and director of the Institute for Stroke and Cerebrovascular Disease at the University of Texas Health Science Center at Houston (UTHealth), and global principal investigator for the PISCES III study.

“We are very excited to partner with ReNeuron and enrol the first patient into the PISCES III study.

“This study represents an important next step in the development of novel cellular therapies for chronic stroke and, to date, is the most advanced clinical trial to determine whether neural stem cells improve recovery in patients chronically disabled by stroke.”

Olav Hellebø, chief executive officer of ReNeuron, added that the company was “delighted” that the first subject had been treated in the PISCES III stroke clinical trial in the US with the CTX stem cell therapy candidate.

“No therapeutic interventions are currently available to improve motor function and quality of life for disabled stroke patients.

“This important clinical trial moves us forward to potentially meeting this very significant unmet need.”