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ReNeuron presents positive data for CTX cell therapy candidate
Cell-based therapeutics developer ReNeuron Group announced on Friday that positive long-term data from the Phase II clinical trial - PISCES II -of its CTX cell therapy candidate for stroke disability was accepted for a podium presentation given on Thursday at the American Heart Association International Stroke Conference 2018.
The AIM-traded company said PISCES II is a single arm, open-label study in which a total of 23 patients living with significant disability resulting from ischaemic stroke were treated with ReNeuron's CTX cell therapy candidate.
It had recently announced positive top-line long-term data from the PISCES II clinical trial, in which response rates in key measures reported at three months after CTX cell treatment were sustained at 12 months post-treatment.
Professor Keith Muir, SINAPSE chair of clinical imaging, clinical director for stroke, Queen Elizabeth University Hospital, Glasgow, and principal investigator for the PISCES II study, presented data at the conference showing upper limb functional recovery was durable and maintained out to 12 months post-treatment, with 30% of patients responding on the ARAT scale, a measure of upper limb mobility.
Data was also presented showing a response rate in 30% of subjects at 12 months post-treatment of at least a one point improvement on the modified Rankin Scale (mRS), a seven-point, clinician-reported global measure of disability or dependence upon others in carrying out activities of daily living.
"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," the ReNeuron board explained.
"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."
Further, data analysis from a pre-specified subgroup of patients in the PISCES II study who had residual upper limb movement was presented, showing the appreciably higher response rate of 43% in these patients on the mRS.
Patients similar to those in the subgroup, with moderate or moderate-to-severe disability and some remaining arm movement, would be the target population for the company's upcoming PISCES III clinical trial with its CTX cell therapy candidate.
"The data presented at the ISC 2018 conference indicate that the CTX therapy has the potential to produce meaningful and sustained improvements in the level of disability or dependence as well as motor function in disabled stroke patients," the board added.
"The PISCES II study also demonstrated that the CTX treatment was well-tolerated in both short and longer term follow-up."
ReNeuron recently announced that the FDA had given regulatory approval for the company to commence a Phase IIb clinical study in the US with its CTX cell therapy candidate for stroke disability.
It said the study, designated PISCES III, is a randomised, placebo-controlled clinical trial involving 110 patients across 25 clinical trial sites in the US.
The primary end-point of the study will be a comparison of the proportion of patients in the treated and placebo arms showing a clinically important improvement on the mRS at six months post-treatment compared with baseline.
Data from the study was expected in late 2019.