ReNeuron Group Plc (LON:RENE) was in demand early on Tuesday after the cell-based therapeutics specialist delivered another encouraging update from its phase II clinical study treating stroke patients with its CTX stem cells.
Last December, ReNeuron reported that seven-out-20 patients taking part in the PISCES II trial saw a discernible improvement in their disability.
The AIM-quoted group said on Tuesday that the positive response rates reported at three months after treatment were sustained at 12 months after treatment, with seven people still showing a “clinically relevant improvement”.
The PISCES II trial also showed that the CTX treatment was well-tolerated both in the short and longer-term.
"We are delighted that the long term follow-up data from the PISCES II clinical trial has shown the potential of our CTX cell therapy candidate to permanently improve function in patients living with chronic consequences following stroke,” said ReNeuron chief executive Olav Hellebø.
“Further, the study we plan to commence early in 2018 will allow critical placebo-controlled data with CTX in stroke disability to be available earlier than originally planned.”
IND application to be lodged “shortly”
ReNeuron confirmed it will “shortly” submit an investigational new drug application to the US Food and Drug Administration to kick off a clinical trial in the US in stroke patients.
Data from that study is expected at some point in the second half of 2019. After that, the company reckons it will need one more study in order to get global marketing approval of the therapy.
Shares were up 2.1% to 1.71p in early deals on Monday.