Evgen Pharma Plc (LON:EVG), a clinical stage drug development company focused on the treatment of cancer and neurological conditions, has today announced an update on its two Phase II clinical trials.
STEM (SFX-01 in the Treatment and Evaluation of Metastatic Breast Cancer) is a multi-centre, Phase IIa clinical trial led by Principal Investigator Dr Sacha Howell of the Christie Hospital in Manchester, UK. The first patient was dosed in the study in January 2017.
Prior to entry to the STEM trial, patients must have previously responded to their current hormone therapy for at least six months but then present with progressive disease, thereby demonstrating the start of resistance to the hormone therapy. Once entered into the trial, patients continue to receive their hormone therapy in addition to SFX-01 and have regular scans through to week 24. Patients discontinue the trial when one of the scans shows disease progression or at week 24.
The Company announces today that the first patient to enter the STEM trial is now approaching week 24, having demonstrated no disease progression for three consecutive scans. On this basis, the Company has initiated a compassionate use programme, so that patients can continue to receive SFX-01 after week 24.
STEM will recruit 60 patients from multiple sites in the UK and from sites in up to four other European countries. Two sites are currently open for recruitment (Manchester, UK, and Brussels, Belgium) and a total of nine patients have been enrolled so far. Due to protracted regulatory submissions in France, Spain and the Czech Republic, the Company is now projecting the final read-out from the study in the second half of calendar year 2018. The Company will issue an interim data analysis in the first half of calendar year 2018.
The primary endpoints of the STEM trial are safety, tolerability and clinical benefit rate (“CBR”) as measured by RECIST (Response Evaluation Criteria In Solid Tumours).
SAS (SFX-01 After Subarachnoid Haemorrhage) is a Phase II clinical trial led by Principal Investigator Diederik Bulters, a neurosurgeon at University Hospital Southampton. The trial will recruit a total of 90 patients. The first patient was dosed in May 2016 and to date 34 patients have been recruited at the Southampton site.
In its second meeting since the start of the SAS trial, the independent Data Safety Monitoring Board (“DSMB”) has analysed unblinded data for safety and confirmed there are no safety issues attributable to SFX-01.
The SAS trial has two arms: in one arm patients receive nimodipine, the current standard of care, plus placebo and in the other patients receive nimodipine plus SFX-01. Having viewed unblinded data, the DSMB has recommended that, going forward, patients should be assigned to the arms of the study on a stratified basis to ensure that both arms comprise patients of equal baseline disease severity. The Company is following the DSMB’s recommendation and recruitment will continue once the stratification process has been designed and implemented.
The Company is pleased to announce that a second SAS trial site has been initiated (Queen Elizabeth Hospital Birmingham, UK) to accelerate patient recruitment. Both sites are expected to recommence patient recruitment in approximately eight weeks. The Company is anticipating read-out from the study around the end of calendar year 2018.
Dr Stephen Franklin, CEO of Evgen Pharma Plc, commented: “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.”
