Angle completes enrolment in Parsortix breast cancer study
Liquid biopsy company Angle announced on Thursday that enrolment for its ‘Parsortix’ FDA clinical study for metastatic breast cancer was now complete.
The AIM-traded firm said it was “grateful” to four US cancer centres - the University of Texas MD Anderson Cancer Center, the University of Southern California Norris Cancer Center, the University of Rochester Wilmot Cancer Center, and the Northwestern University Robert H Lurie Cancer Center - for their efforts in completing enrolment of all of the required 400 evaluable subjects.
Downstream analyses of the samples would now be completed by the centres, and the evaluation of the results from the clinical study and the ongoing analytical studies would be completed, with the aim of a submission to the FDA mid-year, as planned.
The timing of FDA regulatory clearance was dependent on the administration’s review and response to Angle’s submission.
As the company was following a de-novo process for the first potential FDA clearance of a system intended for harvesting cancer cells from patient blood for subsequent analysis, it said it was not possible to predict with certainty how long the process would take.
“Completion of the enrolment for our Parsortix FDA clinical study is a key milestone for Angle,” said founder and chief executive Andrew Newland.
“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.”