Good Progress with FDA Studies

RNS Number : 1112F

Angle PLC

25 October 2018

 

For immediate release

25 October 2018

ANGLE plc ("the Company")

GOOD PROGRESS WITH FDA CLINICAL AND ANALYTICAL STUDIES

Enrolment of over 75% of the subjects for the clinical study complete

FDA clearance would provide further worldwide differentiation for the Parsortix system in the emerging multi-billion dollar liquid biopsy market

ANGLE 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.

Over 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. 

Whilst 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. 

Meanwhile, 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 Parsortix^TM system's rare cell capture and harvest capabilities have emerged that will further differentiate the Parsortix system in the market.

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"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 emerging multi-billion dollar liquid biopsy market."

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, Mo Noonan, Stephanie Cuthbert Matthew Ventimiglia (US)	[phone] [phone]

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

This announcement contains inside information.

Notes for editors

1.   Despite the market for liquid biopsy being forecast to be worth over US$ 14 billion per annum in the United States alone by 2025 (Goldman Sachs), 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 (simple blood test) to be used to provide the cells of interest. Parsortix is the subject of 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. 

ANGLE's analysis technology for proteins and nucleic acids of all types is called Ziplex^® 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 Ziplex system is ideal for measuring gene expression and other markers directly from Parsortix harvests.

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

Furthermore, ANGLE has established formal collaborations with world-class cancer centres.  These Key Opinion Leaders are working to identify applications with medical utility (clear benefit to patients), and to secure clinical data that demonstrates that utility in patient studies.  Details are available here http://www.angleplc.com/the-company/collaborators/

 

END

 

 

RESMIBBTMBJTTFP