Reneuron announced positive clinical data from the PISCES II Phase 2a clinical trial have been published in a peer reviewed journal. The PISCES II trial evaluated the company’s s CTX stem cell therapy candidate for disability resulting from stroke. The data from the trial have been published online in the Journal of Neurology, Neurosurgery, and Psychiatry.
Data from the study were announced by the company in October of 2017 and presented by Professor Keith Muir at the American Heart Association International Stroke Conference 2018 (ISC 2018) in January 2018.
PISCES II was a single arm, open-label study in patients living with significant disability resulting from ischaemic stroke. A total of 23 stable stroke patients with moderate to severe disability were treated with a single dose of 20 million CTX cells a median of seven months post-stroke. Clinically meaningful improvements in disability scales were measured out to 12 months post-implantation. The greatest improvements on the Modified Rankin Scale (mRS), a measure of disability and dependence, were seen in a pre-specified group of fourteen subjects with residual movement of the affected arm (NIHSS Upper Limb <4). Of these patients, 38.5% were responders (at least a one-point improvement on mRS) at six months post treatment and 50% were responders at twelve months post treatment on this measure. A one-point improvement in mRS is proven to be clinically meaningful for patients, both in terms of quality of life and healthcare resources needed to care for them.
PISCES III is an ongoing study. This is a larger, randomized, placebo controlled clinical trial designed to show a significant difference in the proportion of patients with at least a one-point improvement on mRS in a group receiving CTX stem cells compared to a group receiving a sham-surgery procedure.
About CTX stem cell therapy
Reneuron’s CTX stem cell therapy candidate seeks initially to treat those patients who have suffered an ischemic stroke and have been left disabled by it. These patients constitute approximately one half of stroke survivors. ReNeuron’s CTX stem cell therapy candidate for stroke disability consists of a neural stem cell line which has been generated using our proprietary cell expansion and cell selection technologies and then taken through a full manufacturing scale-up and quality-testing process. As such, CTX is a cryopreserved, clinical and commercial-grade cell therapy product capable of treating all eligible patients presenting.
A stroke occurs when blood flow leading to, or in, the brain is blocked (ischaemic stroke) or a blood vessel in the brain ruptures (haemorrhagic stroke), which can result in damage to the nerve cells in the brain and a loss of bodily functions. Stroke is the single largest cause of adult disability in the developed world. Over 150,000 people suffer a stroke each year in the UK, and approximately 800,000 in the US. The vast majority of these strokes are ischaemic in nature.