Evgen Pharma plc (LON:EVG), a clinical stage drug development company focused on the treatment of cancer and neurological conditions, announced today that it has concluded patient recruitment in its STEM Phase IIa trial of SFX-01 in metastatic breast cancer.
STEM is an open label trial that had regulatory approval to recruit 60 patients. Following the favourable interim read-out, announced on 11 June 2018, the Principal Investigator and the Company’s medical adviser believe there is sufficient evidence to conclude that the main aims of the trial, being a favourable safety and tolerability profile and evidence of clinical benefit, have been successfully met. On this basis, the Company has decided that there is no merit in recruiting the full number of patients allowed under the protocol.
As at 24 July 2018, 50 patients had been enrolled in the trial. Any eligible patients currently in screening will also be admitted to the trial.
All eligible patients will continue as per the trial protocol, and will receive SFX-01 until such point as they show clinical progression or reach the end of the trial at 6 months. If they receive clinical benefit for the full duration of the trial, like all other patients in the trial, they will be eligible for entry into the compassionate use programme. On this basis, the final readout will occur around the end of the calendar year; this will include details of the safety, tolerability and the clinical benefit rate observed across all patients.
Dr Sacha Howell, Principal Investigator and Senior Lecturer and Honorary Consultant in Medical Oncology at the Christie NHS Foundation Trust, said: “The STEM trial is an exploratory trial that was designed to demonstrate safety and tolerability with long-term exposure to SFX-01 and to provide evidence that it has anti-tumour activity after failure of at least one and up to three prior hormone therapies. With these objectives in mind, we have sufficient evidence to believe that SFX-01 warrants further investigation through the conduct of a randomised placebo-controlled trial.”
Dr Stephen Franklin, CEO of Evgen Pharma PLC, commented: “We are excited that, so far, the data from our exploratory STEM trial supports further clinical evaluation of SFX-01 and we look forward to the final read-out around the end of the calendar year. The next step is likely to be a placebo-controlled trial, testing SFX-01 in combination with second-line hormone therapy in patients that have failed on CDK4/6 inhibitors. This is the initial setting for which we wish to see SFX-01 approved in metastatic breast cancer.”