Final patient recruited in the STEM Phase IIa trial
- Evgen Pharma announced 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 11th June 2018, the Principal Investigator and the Company’s medical adviser believe there is now sufficient evidence to conclude that the main aims of the trial, being that of a strong safety and tolerability profile together with 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 24th July 2018, 50 patients had been enrolled in the trial although any eligible patients currently in screening will also be admitted to the trial.
- All eligible patients will continue as per the trial protocol, receiving SFX-01 until such point as they show clinical progression or reach the end of the 6 month trial. If they receive clinical benefit for the full duration of the trial, as have all other patients in the trial, they will be eligible for entry into the compassionate use programme.
This is a very positive result. The STEM trial data appears to support further clinical evaluation of STX-01. The final readout should occur around the end of 2018E, providing details of the safety, tolerability and the clinical benefit rate observed across all patients. Subject to this confirming evidence to date, 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 management aims to target SFX-01’s approval in metastatic breast cancer.
Evgen Pharma is a clinical stage drug development company focused on the treatment of cancer and neurological conditions.