Angle PLC – Positive Results from FDA Clinical Study

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce positive results from its Parsortix FDA clinical study for metastatic breast cancer.   

The 400 subject ANG-002 clinical study (the Study) was designed to support a De Novo submission to the United States Food and Drug Administration (FDA) seeking Class II regulatory clearance for ANGLE’s Parsortix^TM system for the intended use with metastatic breast cancer patients. 

The Study has achieved its primary objective to demonstrate the ability of the Parsortix system to capture and harvest cancer cells from the blood of a significant proportion of metastatic breast cancer patients.

The Study has also achieved its exploratory goals by demonstrating that the cells harvested from patient blood using the Parsortix system could be interrogated using different subsequent analysis techniques, including: Wright-Giemsa staining of cytospin preparations for cytopathological evaluation, fluorescent in situ hybridisation (FISH) for evaluation of HER2/neu amplification status, and RT-qPCR for evaluation of cancer related gene expression levels.   The harvested cells were also able to be used for the generation of cDNA libraries of sufficient quality for use in RNA-seq evaluation, full bioinformatic analysis is due in June.  

ANGLE’s ongoing discussions with FDA as part of the De Novo process have recently identified additional analytical study experiments that will be needed to support FDA clearance.  It is helpful that these requirements have been identified ahead of FDA submission.  The additional studies have minimal cost and are expected to be completed to allow FDA submission in early Q4 CY19 offering the prospect of FDA clearance in early CY20. The timing of FDA regulatory clearance is dependent on the FDA’s review and response to our submission.

Further disclosure of data will be reserved to optimise the potential for publication in peer-reviewed journals and to present the data at leading cancer conferences.

ANGLE Founder and Chief Executive, Andrew Newland, commented:

“We are delighted with the positive results from the FDA clinical study.  We are working to complete the remaining analytical study work and the full data analysis and interpretation so that an FDA submission can be made as soon as possible. 

“We believe there is a tremendous opportunity for ANGLE to secure the first ever FDA clearance¹ 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. This clearance, considered the gold standard for approval of medical diagnostic systems globally, would further competitively differentiate the Parsortix system and should lead to an acceleration in commercial adoption of the system in both research and clinical settings.”