Business
Good Progress with FDA Studies
Good Progress with FDA Studies.
About this update from Cellbxhealth Plc
[{"type":"text","content":"\n \nRNS Number : 1112F Angle PLC 25 October 2018 \n\n \n\n\n\nFor immediate release\n\n\n 25 October 2018\n\n\n\n \nANGLE plc (\"the Company\")\n \nGOOD PROGRESS WITH FDA CLINICAL AND ANALYTICAL STUDIES \n \nEnrolment of over 75% of the subjects for the clinical study complete \n \nFDA clearance would provide further worldwide differentiation for the Parsortix system in the emerging multi-billion dollar liquid biopsy market\n \n \nANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is pleased to announce that patient enrolment for its ANG-002 FDA clinical study for metastatic breast cancer continues to make good progress. ANGLE is seeking to become the first ever company to receive FDA clearance for a platform that captures and harvests intact circulating tumour cells (CTCs) from patient blood for subsequent analysis, being one of only three FDA cleared liquid biopsy solutions1. \n \nOver 75% of the required 400 subjects (200 metastatic breast cancer patients and 200 healthy volunteers of a similar age and demographic) have been enrolled into the study to date. \n \nWhilst the enrolment of patients and analysis of results are conducted by independent cancer centres and outside the control of the Company, recent progress now suggests that both the clinical study and associated analytical studies will be completed by the end of Q1 CY 2019. \n \nMeanwhile, extensive analytical studies continue at ANGLE's own laboratories and at the participating clinical centres. As a result of this work, new insights into the ParsortixTM system's rare cell capture and harvest capabilities have emerged that will further differentiate the Parsortix system in the market.\n \nANGLE Founder and Chief Executive, Andrew Newland, commented:\n\"Our significant and sustained efforts to complete the clinical and analytical studies needed to support our FDA submission are progressing well. 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. This would be a key step in establishing the Parsortix system as the system of choice for CTC liquid biopsy, securing a leading position in the emerg...