ANGLE plc announce that enrolment for its Parsortix FDA clinical study for metastatic breast cancer is now complete.
We are grateful to the four leading 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 will now be completed by the centers and the evaluation of the results from the clinical study and the ongoing analytical studies will be completed with the aim of a submission to the FDA mid-year, as planned. The timing of FDA regulatory clearance is dependent on the FDA’s review and response to our submission. As we are following a de-novo process for the first potential FDA clearance1 of a system intended for harvesting cancer cells from patient blood for subsequent analysis, it is not possible to predict with certainty how long this process will take.
ANGLE Founder and Chief Executive, Andrew Newland, commented: “Completion of the enrolment for our Parsortix FDA clinical study is a key milestone for ANGLE. 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 tumor cells from patient blood for subsequent analysis, in the first instance for metastatic breast cancer.”