ReNeuron heartened by stroke trial data
Date
4/17/2015 9:12:56 PM
(MENAFN- ProactiveInvestors) Shares in () rose sharply following an update on a Phase I clinical trial of ’s CTX stem cell therapy for disabled stroke patients.
There have been no cell-related or immunological adverse events across the four ascending dose levels reported in any of the eleven patients treated in the study revealed.
Adverse events reported were related only to the implantation procedure or the patient's underlying medical condition.
Improvements in neurological status and limb function compared to pre-treatment baseline performance were observed within three months of treatment and maintained throughout long term follow-up said.
Improvements in the National Institutes of Health Stroke Scale (NIHSS) - a measure used to objectively quantify the impairment caused by a stroke - were seen in all dose groups.
For all subjects the median baseline score was seven; this improved to five at three months and was sustained at two years follow- up with a median score of five.
Other measures of neuromuscular disability were supportive of the NIHSS improvement.
is currently conducting a UK multi-site Phase II clinical trial (PISCES II) to examine the efficacy of its CTX stem cell treatment in patients disabled by an ischaemic stroke. As a result of observed good safety profile of the treatment the highest cell dose from the PISCES study is being used in the ongoing Phase II study.
As with the PISCES study the Phase II clinical trial involves a single one-off injection of CTX cells into the brain. Subject to patient recruitment initial data from this study are expected around the end of this year told investors.
Meanwhile the long term follow-up data out to at least 24 months in all patients treated in the PISCES Phase I study are being presented by the clinical team from Glasgow's Southern General Hospital on 19th April in a platform presentation at the 2015 European Stroke Organisation Conference (ESOC) taking place in Glasgow.
Later on the results will be submitted for publication in a peer-reviewed clinical journal later this year.
Olav Hellebø chief executive officer of said: “The data confirm the good safety profile of our CTX stem cell treatment in this setting and it is particularly gratifying to see that the functional improvements previously observed in the patients against baseline measurements have been maintained in long term follow up.”
Professor Keith Muir SINAPSE professor of Clinical Imaging Division of Clinical Neurosciences at the University of Glasgow and principal investigator of the PISCES study said: "We continue to be both pleased and encouraged by the data from the PISCES study.
“The long term follow-up data continue to demonstrate the safety and tolerability of the CTX treatment. The evidence of functional improvement warrant further investigation and in this regard we are delighted to be a principal participating centre in the ongoing Phase II efficacy study with CTX."
Shares in were up 7.6% in mid-afternoon trading.
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