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ReNeuron says positive clinical data from Phase 2a trial of its CTX stem cell therapy candidate published in peer-reviewed journal

Data from the PISCES II study were originally presented by Professor Keith Muir at the American Heart Association International Stroke Conference in January 2018

Clinical trial
PISCES II was a single-arm, open-label study in patients living with significant disability resulting from ischaemic stroke

ReNeuron Group PLC (LON:RENE) shares rose on Monday as the firm, a global leader in the development of cell-based therapeutics, has announced 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.

In early trading, ReNeuron shares were 7% higher at 155p.

In a statement, the AIM-listed firm said 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.

READ: ReNeuron interims chart a period of significant progress; out-licence deal talks ongoing

It also noted that 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)".

Olav Hellebø, ReNeuron’s chief executive officer 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."

ReNeuron pointed out that PISCES II was a single-arm, open-label study in patients living with significant disability resulting from ischaemic stroke. 

PISCES III study ongoing

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 and 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.

 -- Adds share price --

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