Data demonstrates key advantages of Parsortix

RNS Number : 1262D

Angle PLC

17 February 2020

 

For immediate release

17 February 2020

ANGLE plc ("the Company")

LEADING KOL PUBLISHES ANALYTICAL AND CLINICAL DATA DEMONSTRATING KEY ADVANTAGES OF PARSORTIX SYSTEM

Hamburg-Eppendorf developed validated standardised Parsortix protocols for use in future clinical trials

Parsortix harvested cells allow for "robust amplification of single cell DNA at excellent quality for subsequent molecular analysis"

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is pleased to announce that University Medical Centre Hamburg-Eppendorf has published results of work undertaken to assess the analytical and clinical performance of Parsortix in multiple metastatic cancer types with the main emphasis on metastatic breast cancer.   

The work was completed as part of the pan-European CANCER-ID consortium funded by the European Innovative Medicine Initiative (IMI), which aims to standardise protocols and validate innovative circulating tumour cell (CTC) detection approaches for future clinical trials.  

The results demonstrated the capability of the Parsortix system to work with multiple different cancer types, using multiple blood preservative tube types, and importantly capturing the full range of CTCs, not just epithelial CTCs.

The researchers demonstrated that the CTCs harvested by the Parsortix system were suitable for "robust amplification of single cell DNA at excellent quality for subsequent molecular analysis".  Even in metastatic NSCLC (non small cell lung cancer) and gastrointestinal cancer, which are known to be problematic for CTC enrichment, the Parsortix workflow harvested CTCs in 46% of patients notwithstanding treatment and disease condition.  The researchers stated in the publication that they had established optimised enrichment protocols, utilising Parsortix, which ensured robust performance.

The research has been published as a peer-reviewed publication in the journal Cancers and may be accessed via https://angleplc.com/library/publications/.   

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"This publication adds to the body of evidence supporting the use of Parsortix in standard practice as part of personalised cancer care.  Hamburg-Eppendorf is considered a leader in Europe in the field and their positive evaluation of Parsortix is an important element in supporting the potential use of Parsortix in future pharma services clinical trials."

As previously announced, following the Q-Submission meeting in January with FDA, ANGLE is now progressing a full De Novo FDA Submission with the prospect of FDA clearance in Q3 CY20, albeit the outcome and timing of the FDA regulatory decision is entirely dependent on the FDA's review and response to the Company's submission. 

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, Sunila de Silva	[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]

The information communicated in this announcement is inside information for the purposes of Article 7 of Regulation 596/2015.

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

Notes for editors

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 a 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® 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 types of downstream analyses. The system is based on a microfluidic device that captures cells based on a combination of their size and compressibility.  The system is epitope independent and can capture all types of CTCs as well as CTC clusters in a viable form (alive).  CTCs enable the complete picture of a cancer to be seen as being a complete cell they allow DNA, RNA and protein analysis and the live cells harvested can be cultured.  The Parsortix technology is the subject of 24 granted patents in Europe, the United States, China, Australia, Canada, India, Japan and Mexico with three extensive families of patents are being progressed worldwide.  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 clinical study and associated analytical studies 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 200 patient clinical verification study.

ANGLE's technology for the multiplex evaluation of proteins and nucleic acids of all types is called the HyCEADTM 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 extremely sensitive and 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 Abbott, Philips and QIAGEN, 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 28 peer-reviewed publications and numerous publicly available posters, available on our website.

 

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