-- adds chief executvie comment --
Stem cell specialist ReNeuron (LON:RENE) has started recruitment for the US Phase I/II trial for its treatment for eyesight loss condition retinitis pigmentosa.
US regulator, the FDA, has fast-tracked the treatment and fifteen patients will take part in the trial at the Massachusetts Eye and Ear Infirmary in Boston.
Results are expected in the second half of 2016 and if successful, ReNeuron will file for a Phase II/III clinical trial in 2017. This trial is expected to be the basis for subsequent marketing authorisation filings in both the US and Europe.
It is one of four programmes ReNeuron is currently working on currently and just one of these being successful would be worth a multiple of the company’s current value said Olav Hellebø, chief executive.
A phase I/II trial for ReNeuron’s stroke disability treatment, CTX, is going well enough for the phase II/III trial possibly to take place ahead of schedule.
Sufficient suitable patients have already been identified to complete the first cohort in the study.
As a result, ReNeuron may look to curtail the Phase II study early and start a controlled Phase II/III clinical trial in patients with motor disability as a result of a stroke.
A phase I trial of the CTX stem cell therapy as a treatment for critical limb ischaemia is (CLI) is also underway with results due in the first half of 2016.
Hellebø added that as well as the clinical trials, the company’s exosome technology platform was also developing well as a potential nanomedicine targeting cancer and as a potential new delivery system in gene therapy.
Losses for the half year were £4.5mln (£4.1mln) reflecting the current development spending.
ReNeuron raised £68mln in August and ended the half year to September with cash of £72mln. That was enough funds to progress all of four of its programmes, added Hellebø.