Positive Phase 2a stroke clinical data published

ReNeuron Group plc (AIM: RENE), a global leader in the development of cell-based therapeutics, is pleased to announce the publication in a peer reviewed journal of positive clinical data from the PISCES II Phase 2a clinical trial of its CTX stem cell therapy candidate for disability resulting from stroke.

Data from the study were originally presented by Professor Keith Muir at the American Heart Association International Stroke Conference 2018 (ISC 2018) in January 2018, having been announced by the Company in October 2017.

Data from the PISCES II clinical trial have been published online in the Journal of Neurology, Neurosurgery, and Psychiatry in a paper titled Intracerebral implantation of human neural stem cells and motor recovery after stroke: multicentre prospective single-arm study (PISCES-2)”, Keith Muir et al. http://jnnp.bmj.com/cgi/content/full/jnnp-2019-322515

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.  For example, improving from mRS 3 to 2 means that a person with a stroke regains their ability to live independently; perhaps returning home from a care facility, or enabling a spouse or carer to return to work.

The ongoing PISCES III study is a larger, randomised, 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.

Olav Hellebø, Chief Executive Officer of ReNeuron, commented:

“We are delighted to see the positive results of the PISCES II clinical trial of our CTX cell therapy candidate for stroke disability published in this highly regarded peer-reviewed journal.”