ReNeuron progresses stroke clinical trial

ReNeuron has reported further progress in the clinical trial of its ReN001 stem cell therapy for disabled stroke patients, known as the PISCES study.

ReNeuron has reported further progress in the clinical trial of its ReN001 stem cell therapy for disabled stroke patients, known as the PISCES study.

The third and penultimate batch of three patients have all been successfully treated with ReN001 and discharged from hospital with no acute safety issues arising. This follows approval last month by the independent Data Safety Monitoring Board (DSMB) for the study to proceed to completion of dosing of this batch of patients.

MoneyWeek

Subscribe to MoneyWeek today and get your first six magazine issues absolutely FREE

Get 6 issues free
https://cdn.mos.cms.futurecdn.net/flexiimages/mw70aro6gl1676370748.jpg

Sign up to Money Morning

Don't miss the latest investment and personal finances news, market analysis, plus money-saving tips with our free twice-daily newsletter

Don't miss the latest investment and personal finances news, market analysis, plus money-saving tips with our free twice-daily newsletter

Sign up

In June of this year, interim data from the PISCES study from the first five patients treated was presented by the Glasgow clinical team at the 10th Annual Meeting of the International Society for Stem Cell Research (ISSCR) in Yokohama, Japan. Reductions in neurological impairment and spasticity were observed in all five patients compared with their stable pre-treatment baseline performance and these improvements were sustained in longer term follow-up.

Based on the above progress, the company announced last month that, ahead of plan, it had submitted an application to the UK regulatory authority to commence a multi-site Phase II clinical trial to examine the efficacy of ReN001 in patients disabled by an ischaemic stroke.

This trial is designed to recruit from a well-defined population of patients between two and four months after their stroke, which the company and its clinical collaborators currently believe will be the optimum treatment window for the therapy. Subject to continuing positive progress with the PISCES study, and subject to regulatory and ethical approvals, the company hopes to be able to commence the Phase II stroke study in mid-2013. The proposed study is expected to take up to 18 months to complete.

ReNeuron's ReN001 stem cell therapy is being administered in ascending doses to a total of 12 stroke patients who have been left disabled by an ischaemic stroke, the most common form of the condition.

This news should also have positive read-across for Aim-listed Angel Biotechnology, which supplies the stem cells used in the study.

CM

MoneyWeek

MoneyWeek is written by a team of experienced and award-winning journalists, plus expert columnists. As well as daily digital news and features, MoneyWeek also publishes a weekly magazine, covering investing and personal finance. From share tips, pensions, gold to practical investment tips - we provide a round-up to help you make money and keep it.