Patient recruitment for trial with expanded neural stem cell product will begin in April.
Stem cell therapeutics company ReNeuron raised about £4.7 million (almost $7.3 million) before expenses in a fundraising round with new and existing investors. The financing is conditional on shareholder approval in March.
ReNeuron says that the net proceeds will be used primarily to progress its lead ReN001 stem cell stroke therapy through Phase I trials and carry out late preclinical studies with its peripheral arterial disease candidate, ReN009. Funding will also be allocated to optimize and scale-up the company’s second-generation CTX stem cell line.
On February 10, ReNeuron confirmed that the U.K. Gene Therapy Advisory Committee (GTAC) green-lighted a proposed first-in-man clinical trial with its ReN001 stem cell therapy for stroke. Clearance of the trial by the GTAC follows regulatory approval by the U.K. Medicines and Healthcare Products Regulatory Agency last year.
ReNeuron claims that the study will be the world’s first to use expanded neural stem cells in this indication. ReN001 will be administered to patients who have been left disabled by an ischemic stroke. Patient recruitment is expected to start in April.
The trial is designed primarily to test the safety profile of ReN001 in ischemic stroke patients at a range of cell doses. A number of efficacy measures will also be evaluated over the course of the trial. Patients in the trial will be monitored for two years, with longer-term, follow-up procedures in place thereafter.