ENROLMENT COMPLETE FOR FDA CLINICAL STUDY

RNS Number : 1007S

Angle PLC

07 March 2019

 

For immediate release

7 March 2019

ANGLE plc ("the Company")

ENROLMENT COMPLETE FOR FDA CLINICAL STUDY

Submission to the FDA expected mid-year as planned

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to 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 centres 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 tumour cells from patient blood for subsequent analysis, in the first instance for metastatic breast cancer."

For further information ANGLE:

ANGLE plc	[phone]
Andrew Newland, Chief Executive Ian Griffiths, Finance Director
finnCap Ltd (NOMAD and Joint Broker) Corporate Finance - Carl Holmes, Simon Hicks, Max Bullen-Smith ECM - Alice Lane	[phone]
WG Partners (Joint Broker) Nigel Barnes, Nigel Birks, Andrew Craig, Chris Lee	[phone]
FTI Consulting Simon Conway, Ciara Martin Matthew Ventimiglia (US)	[phone] [phone]

This announcement contains inside information.

For Frequently Used Terms, please see the Company's website on http://www.angleplc.com/the-parsortix-system/glossary/

Notes for editors

1.   Despite the estimated addressable market potential for liquid biopsy of greater than US$100 billion per annum across all cancer types in the United States alone (Frost and Sullivan, November 2018), to date, the FDA has cleared only two liquid biopsy applications.  The first clearance, for CellSearch, was for CTC enumeration (counting) to assess prognosis in metastatic breast, colorectal or prostate cancers.  This contrasts with ANGLE's intended use to capture and harvest CTCs for subsequent analysis.  The second clearance, for a liquid biopsy application on the Roche Cobas platform, was for utilising ctDNA (fragments of dead cancer cells) to investigate the presence of an EGFR gene mutation in non-small cell lung cancer.  ANGLE is seeking to become the first company ever to obtain FDA clearance for a liquid biopsy platform that will capture and harvest CTCs for subsequent analysis, in the first instance for metastatic breast cancer patients.

About ANGLE plc www.angleplc.com 

ANGLE is a world leading liquid biopsy company with sample-to-answer solutions. ANGLE's proven patent protected platforms include an epitope-independent circulating tumor cell (CTC) harvesting technology and a downstream analysis system for cost effective, highly multiplexed analysis of nucleic acids and proteins.

ANGLE's cell separation technology is called the Parsortix^TM system, and it enables a liquid biopsy (a simple blood test) to be used to provide the cells of interest to the user in a format suitable for multiple downstream subsequent analyses.  CTCs enable the complete picture of a cancer to be seen as they allow DNA, RNA and protein analysis and the live cells harvested can be cultured.  The Parsortix technology is the subject of 21 granted patents in Europe, the United States, Canada, India, China, Japan and Australia with three extensive families of patents are being progressed worldwide.  The system is based on a microfluidic device that captures cells based on a combination of their size and compressibility.  The Parsortix system has a CE Mark in Europe for the indicated use and FDA clearance is in process for the United States with a 400 subject study in metastatic breast cancer. ANGLE is seeking to be the first ever FDA cleared CTC harvesting system and only the third ever FDA cleared liquid biopsy test.  ANGLE has already undertaken two separate 200 subject clinical studies under a program designed to develop an ovarian cancer pelvic mass triage test, with the results showing best in class accuracy (ROC-AUC) of 95.1%.  The pelvic mass triage assay has undergone further refinement and optimisation, and is currently in the process of a clinical verification study.

ANGLE's technology for the multiplex evaluation of proteins and nucleic acids of all types is called the HyCEAD^TM Ziplex^® platform and is based on a patented flow through array technology.  It provides for low cost, highly multiplexed, rapid and sensitive capture of targets from a wide variety of sample types. A proprietary chemistry approach (the HyCEAD method) allows for the capture and amplification of over 100 biomarkers simultaneously in a single reaction. The HyCEAD Ziplex system is ideal for measuring gene expression and other markers directly from Parsortix harvests and was used in the ovarian cancer pelvic mass triage test to achieve best in class accuracy (ROC-AUC) of 95.1%.

ANGLE's proprietary technologies can be combined to provide automated, sample-to-answer results in both centralised laboratory and point-of-use cartridge formats.

ANGLE has established formal collaborations with world-class cancer centres and major corporates such as QIAGEN, Abbott and Philips, and works closely with leading CTC translational research customers.  These Key Opinion Leaders (KOLs) are working to identify applications with medical utility (clear benefit to patients), and to secure clinical data that demonstrates that utility in patient studies.  The body of evidence as to the benefits of the Parsortix system is growing rapidly from our own clinical studies in metastatic breast cancer and ovarian cancer and also from KOLs with 18 peer-reviewed publications and numerous publicly available posters, available on our website.

 

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