ANGLE PLC (LON:AGL, OTCQX:ANPCY) said it had passed a “key milestone” following the completion of recruitment to a phase III clinical study to assess the potential of its liquid biopsy in metastatic breast cancer.
A total of 400 people will be screened using the Parsortix system, which harvests tumour cells. The work is being carried out at world-leading cancer centres in Texas, California and Illinois.
Results from the trial will be submitted to the Food & Drug Administration by mid-year as planned.
However, ANGLE cautioned that the timeline, once the FDA has received all the data, is uncertain as researchers are following a completely new protocol for an entirely unique product – in other words, the regulator doesn’t have an established blueprint or tick-sheet to follow.
Chief executive Andrew Newland said: “We believe there is a tremendous opportunity for ANGLE to secure the first ever FDA clearance for a platform that captures and harvests intact circulating tumour cells from patient blood for subsequent analysis, in the first instance for metastatic breast cancer."