Evgen Pharma PLC (LON:EVG) saw its shares jump almost 12% higher this morning after the drug development company reported positive updates on two Phase II clinical trials for its SFX-01 treatment with “no safety or tolerance issues reported to date”.
In a statement, the AIM-listed group said the first patient dosed in its STEM clinical study, testing SFX-01 in the treatment and evaluation of metastatic breast is now approaching week 24 – having been treated in January – and has demonstrated “no disease progression for three consecutive scans. “
On this basis, Evgen said it has initiated a “compassionate use programme”, so that patients can continue to receive SFX-01 after week 24.
It added that STEM will now recruit 60 patients from multiple sites in the UK and from sites in up to four other European countries.
The firm added, due to protracted regulatory submissions in France, Spain and the Czech Republic, it is now projecting the final read-out from the STEM study in the second half of calendar year 2018.
Second SAS trial site initiated at Queen Elizabeth Hospital in Birmingham
In SAS, the other Phase II trial using SFX-01 for subarachnoid haemorrhage treatment, Evgen said that to date 34 patients have been recruited at the Southampton site, with the first dosed in May 2016, and it will recruit a total of 90 patients.
The group noted that, in its second meeting since the start of the SAS trial, the independent Data Safety Monitoring Board also confirmed there are no safety issues attributable to SFX-01.
The company also announced that a second SAS trial site has been initiated at Queen Elizabeth Hospital in Birmingham to accelerate patient recruitment.
Evgen said it is anticipating read-out from the SAS study around the end of calendar year 2018.
Encouraged by requirement to initiate a compassionate use programme
Dr Stephen Franklin, Evgen Pharma’s CEO said: "We are very pleased that there have been no safety or tolerance issues reported to date on either of our two Phase II trials and we are delighted to have successfully initiated a second site for the SAS trial.
“In the STEM trial, we will provide the market with an interim data analysis in the first half of calendar year 2018 and we are encouraged by the requirement to initiate a compassionate use programme."
In mid-morning trading, Evgen shares were up 11.7%, or 2.25p at 21.5p.
In a note to clients, broker Northland Capital said: “Positive news for Evgen Pharma with the Company making significant progress, despite a minor delay, in both of its phase two trails.
“There have been no safety issues or tolerance issues for either of the Phase II trials to date and final read-outs from both the studies are expected next year, a major milestone for the Company.”