07:00 Tue 31 Oct 2017
ReNeuron Group plc - Positive stroke clinical data & regulatory update
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AIM: RENE |
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Positive stroke clinical data & regulatory update
Long term data from Phase II stroke clinical trial confirm positive results seen after three months
Results indicate that CTX cell therapy has potential to improve long term outcomes in disability, dependence and motor function in disabled stroke patients
The Company is pleased to announce that the positive response rates in key measures reported at three months after treatment in the PISCES II clinical trial were sustained at 12 months after treatment. PISCES II is a single arm, open-label study in patients living with significant disability resulting from ischaemic stroke. The Company announced positive initial data from the study in
At 12 months post-treatment, the response rates seen in the key measures of disability and dependency were maintained. The primary efficacy measure of the PISCES II study, motor function using the Action Research Arm Test (ARAT), improved between three and 12 months post-treatment. Importantly, the Modified Rankin Scale (mRS) response rate, a measure of disability and dependence, was maintained with 7 out of 20 patients (35%) showing a clinically relevant improvement. It is this measure of disability and dependence that is likely to be carried forward as a primary endpoint in future pivotal studies with CTX in this indication.
The PISCES II study also demonstrated that the CTX treatment was well tolerated in both short and longer term follow-up. Detailed safety and efficacy data from the study will be presented at a forthcoming medical conference.
These positive long term results are highly encouraging, indicating that the CTX therapy has the potential to produce meaningful and sustained improvements in disability as well as motor function in disabled stroke patients. No therapeutic interventions are currently available to improve motor function and quality of life for disabled stroke patients, with physical rehabilitation measures being the current standard of care.
The Company will, as planned, shortly submit an Investigational New Drug application to the
Professor
"It is very encouraging to see that the improvements observed earlier in the PISCES II study have been maintained at the 12 month mark. As many patients live for the remainder of their lives with disability following a stroke, it is important that benefits from new treatments are maintained over the long term. In this regard, the safety and side effects of treatments are also important; we are pleased to see that the initial safety profile of CTX in this study has also not changed with longer term follow up. We look forward to the next phase of CTX development with investigation in randomised, placebo-controlled studies."
"We are delighted that the long term follow-up data from the PISCES II clinical trial has shown the potential of our CTX cell therapy candidate to permanently improve function in patients living with chronic consequences following stroke. Further, the study we plan to commence early in 2018 will allow critical placebo-controlled data with CTX in stroke disability to be available earlier than originally planned."
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About the PISCES II clinical trial
The PISCES II clinical trial is a
About
CTX has been shown to be safe and well-tolerated in an initial
The CTX cells that were used in the both the PISCES I and PISCES II clinical trials were taken from the existing manufactured cell banks that will form the basis of the eventual marketed product. There will therefore be no need to re-derive and test new CTX cell lines for subsequent clinical trials or for the market - all such cells can simply be expanded from the existing banked and tested product.
About stroke
Approximately 150,000 people suffer a stroke in the
Approximately one half of all stroke survivors are left with permanent disabilities as a result of the damage caused to brain tissue arising from the stroke. The annual health and social costs of caring for these patients is estimated to be in excess of
The only current treatments for ischaemic stroke patients occur in the acute phase of the condition (within several hours of the stroke). During this phase, anti-clotting agents can be administered to dissolve the clot causing the blockage in blood flow to the brain or, alternatively, retrieval devices can be used to remove the clot and restore blood flow. Only a small proportion of patients are currently eligible to be treated in this way.
Beyond the acute phase, there are no existing treatments, other than preventative or rehabilitation measures, to alleviate the disabilities suffered by stroke patients who have survived their stroke.
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