As a result of the positive data from the PISCES II study, the FDA approved the commencement of a randomised, placebo-controlled, Phase IIb clinical trial in the US in patients living with chronic stroke disability (PISCES III). This trial is underway, with plans to enrol approximately 130 patients across up to 40 centres in the US, but is currently on hold due to Covid-19 related restrictions. and will remain suspended in the US for the foreseeable future.
Following a review of programme priorities, this trial will remain suspended in the US for the foreseeable future; clinical trial sites will be kept open and patients already treated will be followed up over time in line with the clinical trial protocol.
The Company’s stroke disability programme with its CTX cell therapy candidate will continue through regional partnerships. ReNeuron’s exclusive licensing partner in China, Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. (“Fosun Pharma”), will develop the Company’s CTX cell therapy candidate for stroke disability in the licensed territory (Greater China including Hong Kong, Macao and Taiwan) where the Company has the potential to benefit from future operational and regulatory milestones under this out-license agreement. Clinical trial applications have recently been filed by Fosun Pharma to open clinical sites in the licensed territory to build on the clinical data already generated in the US.
The primary efficacy objective for PISCES III is to assess the effect of CTX drug product on the change in degree of dependency and disability from baseline as measured by the modified Rankin Scale (mRS) at 6 months post-treatment. The mRS is a well-established, 7-point, clinician-reported global measure of functional disability in patients and of their dependence upon others in carrying out activities of daily living. A 1 point improvement from baseline on the mRS is considered clinically meaningful as it represents a stroke patient’s ability to function more independently.
The target population for PISCES III is patients, who have stabilised following an ischemic stroke 6-24 months prior to treatment, with moderate to moderately severe functional disability requiring help from others to carry out activities of daily living or to ambulate.