For immediate release
25 February 2019
ANGLE plc ("the Company")
LEADING CUSTOMER DEMONSTRATES NEW USE FOR PARSORTIX RESULTING IN A 30-FOLD INCREASE IN HARVESTED CANCER CELLS FOR ANALYSIS
Viable cancer cells harvested from diagnostic leukapheresis (DLA) samples for key downstream processes such as in vitro culture
Success achieved with cryopreserved DLA product demonstrates long term stability for Parsortix system separation
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is pleased to announce that one of its leading customers, the Disseminated Cancer Cell Network (DCCNet), Duesseldorf, an interdisciplinary team of researchers and clinicians whose goal is to better understand systemic disease in cancer and to improve individualised therapy in cancer patients, has published new results in a peer-reviewed journal of work done to harvest circulating tumor cells (CTCs) from diagnostic leukapheresis (DLA) samples.
Leukapheresis is a standard procedure routinely used in the clinic to enrich mononuclear cells (certain types of white blood cells (WBCs)) from blood for various applications, including stem cell harvest, with the remainder of the blood returned to the circulation. The DCCNet had previously published that during DLA, several litres of patient blood can be processed resulting in a DLA product of typically just 40ml containing primarily WBCs but also CTCs. They demonstrated that DLA results in more patients with CTCs harvested and an increase of the median CTC numbers by 30-fold compared to analysis of blood samples. The method has been validated by the DCCNet and a European multi-centre study (CTCTrap) in metastatic prostate and breast cancer patients, demonstrating that the workflow yields significantly higher CTC numbers and that the procedure could be safely performed in different clinical environments.
New research on this topic has now been published by the DCCNet at the University Hospital and Medical Faculty of the Heinrich-Heine University of Duesseldorf as a peer-reviewed publication in the journal Clinical Chemistry and is available at https://angleplc.com/library/publications/.
The researchers found that the ParsortixTM system is highly effective in reducing the WBC background from DLA products without interfering with the viability of captured CTCs. This is a major prerequisite to allow successful processing of the DLA product in future clinical situations with low CTC numbers and to enable CTC culturing. Without Parsortix enrichment, WBCs rapidly outgrew the CTC cultures. The increased number of viable CTCs and the enhanced sample purity improved the ability to culture the CTCs. Culturing CTCs is a challenging task and this approach opens the potential for chemo-sensitivity testing in-vitro on isolated and cultured CTCs to determine which drugs may benefit the patient.
The researchers also demonstrated that the DLA sample could be cryopreserved and stored with minimal CTC loss prior to processing with the Parsortix system. The cryopreserved CTCs retained their viability and genomic aberrations and mutation profiles were unchanged. The researchers believe that the DLA process is useful where the patient has a low number of CTCs and a simple blood test is unlikely to recover sufficient CTCs whereas the DLA process samples 200x more blood volume and is more likely to recover CTCs.
Dr Hans Neubauer, University Hospital and Medical Faculty of the Heinrich-Heine University of Duesseldorf commented:
"The use of diagnostic leukapheresis blood product provides larger numbers of CTCs than a normal blood sample. The Parsortix system provides an easy solution for enriching the sample and harvesting these CTCs keeping the cells alive and undamaged. The workflow we have developed to culture these cells will allow an intensification of research into new diagnostic and therapeutic solutions."
ANGLE Founder and Chief Executive, Andrew Newland, commented:
"The DLA approach processes much larger volumes of patient blood opening the potential for use of the Parsortix system even when, due to patient condition, there are only very few CTCs present. Cryopreservation is important as it allows patient samples to be stored for many years and then analysed by Parsortix once patient outcome is known."
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Andrew Newland, Chief Executive
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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
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 ParsortixTM system and it enables a liquid biopsy (simple blood test) to be used to provide the cells of interest. 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. Parsortix is the subject of 21 granted patents in Europe, the United States, Canada, India, China, Japan and Australia and three extensive families of patents are being progressed worldwide. The system is based on a microfluidic device that captures live 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 undertaken 400 subject clinical studies in an ovarian cancer pelvic mass triage test that achieved best in class accuracy (ROC-AUC) of 95.1% and is being optimised.
ANGLE's analysis technology for proteins and nucleic acids of all types is called the HyCEAD 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 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 the 95.1% accuracy.
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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