LONDON (Alliance News) - Evgen Pharma PLC said Wednesday it has concluded its patient recruitment for its STEM Phase IIa trial of SFX-01 in metastatic breast cancer.
Following the favourable interim read-out for the trial, the principal investigator and the company's medical adviser believed there was sufficient evidence to say the main aims of the trial had been met.
The aims included a favourable safety and tolerability profile and evidence of clinical benefit. As a result of these aims being met, the company decided no more patients will be recruited to the trial.
Evgen said all eligible patients will continue as per trial protocol and will receive SFX-01 until such point they show clinical progression or reach the end of the trial at six months.
Chief Executive Officer Stephen Franklin said: ''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."
Shares in Evgen Pharma were down 2.8% Wednesday at 17.25 pence each.