ReNeuron Group (RENE) , focused on the development of stem cell-based therapeutics, has treated the first patient in Phase IIb of its CTX cell therapy clinical study for stroke disability.
The study, PISCES III, is “a randomised, placebo-controlled clinical trial involving 110 patients across 40 clinical trial sites in the US.”
The patients included in the trial are those who have developed a stable disability, typically a dependence on others to carry out daily activities or walk, 6 to 12 months after suffering a stroke. Once in the trial, the patients randomly receive either the CTX therapy or a placebo treatment.
Through the PISCES III study, ReNeuron hopes to compare the proportion of patients in the two groups who showed 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, the initial findings of phase II of a clinical trial typically disclosed to inform key stakeholders, are expected in early next year.
Should the PISCES III study yield productive results, it would be an essential first step in addressing strokes, which are the leading cause of death and disability in the UK. Clearly, the commercialisation of such a product would be substantial.
ReNeuron CEO Olav Hellebø is “delighted” with PISCES III’s progress as “no therapeutic interventions are currently available to improve motor function and quality of life for disabled stroke patients.” This puts PISCES III squarely in line with ReNeuron’s overall guiding philosophy to implement cell therapies in the hopes of “targeting areas of significant unmet or poorly met medical need.”For more news and updates on ReNeuron Group: