First Patients Treated with ReN001 Discharged

[Jeannine]

First Patients Treated with ReN001 Discharged
Drug Discovery & Development - March 03, 2011

http://www.dddmag.com/news-First-Pat...rged-3311.aspx

ReNeuron Group plc provides an update on progress with the PISCES clinical trial of its ReN001 stem cell therapy for disabled stroke patients. The PISCES study (Pilot Investigation of Stem Cells in Stroke) is the world’s first fully regulated clinical trial of a neural stem cell therapy for disabled stroke patients. Stroke is the third largest cause of death and the single largest cause of adult disability in the developed world.

The Company is pleased to report that the first two patients treated in the clinical trial are both well. Both patients were successfully treated with ReN001 with no acute safety issues arising. Both patients were discharged two days after their respective treatments and are back in their local communities in the Greater Glasgow area. The first patient treated has now been assessed at three months post-treatment and has experienced no adverse reactions or effects relating to the therapy.

The final patient in the first dose cohort has consented to treatment and, assuming a successful pre-treatment evaluation period, is expected to be dosed in May. On this basis, the Data Safety Monitoring Board would be expected to review data from the first dose cohort in August and, all being well, give approval for the trial to move on to a higher dose cohort at that time. The Company therefore expects that this higher dose cohort of three further patients would have been treated by the end of this year assuming no significant recruitment delays.

As the PISCES clinical trial continues into longer term follow-up of the patients treated, and into treatment of the higher dose cohorts, a number of treatment efficacy measures will be evaluated over time, including structural and functional MRI imaging measures as well as a number of tests of sensory, motor and cognitive functions. Although the primary endpoints of the clinical trial relate to the safety and tolerability of the ReN001 treatment, the Company hopes to use these potential efficacy measures in the design of subsequent clinical studies where efficacy of the treatment would be the primary endpoint.

The remaining dose cohorts in the PISCES trial are expected to be treated in 2012, at which point the Company intends to have discussed and agreed its subsequent clinical development strategy for ReN001 with the relevant regulatory authorities both in the UK and beyond. The Company is also exploring the clinical potential of its lead CTX stem cell line in other categories of the stroke patient population and in other neurological conditions where the mechanisms of action of the cells may be relevant. This is with a view to commencing further clinical trials in these indications as quickly as possible, based on the very significant pre-clinical safety and efficacy data already in existence with the CTX cells, as well as the emerging early clinical data from the PISCES trial. The Company will provide further updates on these activities, as well as progress with its other therapeutic programmes in peripheral arterial disease and retinitis pigmentosa, in due course.

The PISCES clinical trial is being conducted in Scotland at the Institute of Neurological Sciences, Southern General Hospital, Greater Glasgow and Clyde NHS Board. In this Phase I single administration dose escalation safety study, ReNeuron’s ReN001 stem cell therapy is being administered to a total of 12 stroke patients who have been left disabled by an ischaemic stroke, the most common form of the condition. The Principal Investigator for the trial is Professor Keith Muir, SINAPSE Professor of Clinical Imaging, Division of Clinical Neurosciences at the University of Glasgow. Patients in the clinical trial will be monitored for two years, with longer term follow-up procedures in place thereafter.

Date: March 3, 2011
Source: ReNeuron Group plc