LONDON (Alliance News) - ReNeuron Group PLC said Tuesday that its core therapeutic programme remains on track toward achieving clinical milestones over the next 18 months as the company continues to search for a new Chief Executive Officer.
In a trading update released ahead of its annual general meeting Tuesday, the UK-based stem cell therapy company said it has now dosed the first patient in its Phase II clinical trial for its ReN001 cell therapy candidate for stroke disability and its Phase I clinical trial of the ReN009 cell therapy candidate for critical limb ischaemia, after opening recruitment in June.
The Phase II efficacy study with ReN001 will recruit up to 41 stroke patients at up to ten clinical sites across the UK. "The primary endpoint is a meaningful improvement in upper limb function in disabled stroke patients six months post-stroke to a degree that would support reimbursement of the therapy by healthcare payers on a Quality Adjusted Life Year basis," said the company.
The Phase I safety study with ReN009 is a single centre dose escalation study in nine patients with lower limb ischaemia and is being conducted at Ninewells Hospital, Dundee, Scotland.
The Phase II clinical trial with ReN001 is on course to have generated six month follow-up data by the end of 2015, with results from the Phase I study with ReN009 expected to be announced in the first-half of 2015, said ReNeuron.
The AIM-listed company said final pre-clinical work on ReN003, its cell therapy candidate for retinitis pigmentosa, is proceeding as planned and that it remains on track to file an Investigational New Drug application in early 2015 to commence a Phase I/II clinical trial with ReN003 in the US.
ReNeuron also said its exosome programme is proceeding well, with pre-clinical efficacy studies underway in order to determine the disease areas to target for clinical development with exosome-based therapies in the future, and that it remains on track with plans to relocate ReNeuron's operations to a state-of-the-art manufacturing and development facility at Pencoed, near Cardiff in South Wales, in the Spring of 2015.
The company said its planned recruitment of a new CEO for the business is proceeding well and that it has "been impressed by the exceptional quality of applicants for the role." ReNeuron said it expects to be able to conclude the recruitment process shortly.
The company began searching for a new CEO in April as current Chief Executive Michael Hunt prepares to move to the role of chief financial officer. Hunt will remain as chief executive until a replacement is secured.
"Our core therapeutic programmes remain on track towards further important clinical milestones over the next 18 months. In particular, the commencement of dosing of patients in two new clinical trials, in stroke and limb ischaemia, marks another significant step in ReNeuron's evolution into a fully-fledged clinical development business and a leading player in the increasingly exciting field of cell therapy and regenerative medicine," said Hunt in the statement Tuesday.
In July the company expressed confidence in its future as it continued to develop its stem-cell therapies towards commercialisation, as it posted a widened pretax loss of GBP7.8 million for the full-year, up on the GBP7.1 million the previous year, hit by higher research and development costs, as it benefited from GBP662,000 in grants during the year.
Shares in ReNeuron Group were Tuesday morning trading 5.00% lower at 3.61 pence per share.
By Alice Attwood; aliceattwood@alliancenews.com; @AliceAtAlliance
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Reneuron (RENE)