First patient treated in US stroke clinical trial
ReNeuron Group plc (AIM: RENE), a global leader in the development of cell-based therapeutics, is pleased to announce that the first patient has been treated in the US Phase IIb clinical study of the Company’s CTX cell therapy candidate for stroke disability.
The study, designated PISCES III, is a randomised, placebo-controlled clinical trial involving 110 patients across 40 clinical trial sites in the US. Patients with stable post-stroke disability are entered into the study 6 to 12 months after their stroke and are randomised to receive either the CTX therapy or placebo treatment.
The primary end-point of the study is a comparison of the proportion of patients in the treated and placebo arms showing a clinically significant improvement on the Modified Rankin Scale, a measure of disability and dependence, at 6 months post-treatment compared with baseline. Top-line results from the study are expected in early 2020.
Further information on the PISCES III clinical trial can be found on the Company’s website at www.reneuron.com and on the study’s dedicated website at www.pisces3.org.
Sean I. Savitz MD, 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, commented:
“At McGovern Medical School at UTHealth, we have been studying cellular therapies as a novel treatment for stroke over the past 10 years. 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, commented:
“We are delighted that the first subject has been treated in the PISCES III stroke clinical trial in the US with our 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.”