ENCOURAGING PROGRESS IN ANG-002 FDA CLINICAL STUDY

RNS Number : 1161Q

Angle PLC

04 June 2018

 

For immediate release

4 June 2018

ANGLE plc ("the Company")

ENCOURAGING PROGRESS IN ANG-002 FDA CLINICAL STUDY

Four leading US cancer centres now initiated with enrolment of over 80 subjects completed

Continue to expect the clinical and analytical studies to complete in H2 CY 2018

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 is making encouraging progress.  ANGLE is seeking to become the first ever company to receive FDA clearance for a platform that captures and harvests intact circulating tumor cells (CTCs) from patient blood for subsequent analysis, being one of only three FDA cleared liquid biopsy solutions¹.

Over 80 subjects have so far been enrolled out of a required 400 subjects for the study (200 metastatic breast cancer patients and 200 healthy volunteers of a similar age and demographic).  This has been achieved with two centres being open to enrolment since April. Two additional centres were opened to enrolment at the end of May, so there are now four leading US cancer centres actively recruiting patients for the ANG-002 clinical study and enrolment is expected to begin accelerating.

The study is blinded and results will not be known until the trial is completed.  The primary endpoint of the study is the cytological evaluation of harvested cells by a qualified pathologist to confirm that CTCs are harvested from metastatic breast cancer patients but not from healthy volunteers. Exploratory endpoints include analysis of harvested cells with quantitative RT-PCR, analysis with fluorescence in situ hybridisation (FISH) and analysis with whole transcriptome sequencing (RNA-Seq), being three of the primary types of downstream analysis beyond cytological analysis.

While enrolment of subjects into this study is under the control of the independent cancer centres and outside the Company's direct control, the progress reported today suggests that both the clinical study and the associated analytical studies will complete, as planned, in H2 CY 2018. 

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"We are pleased to announce today that patient enrolment to date for our FDA study has been encouraging and we now have four leading US cancer centres actively recruiting subjects for the study. We continue to believe there is a tremendous opportunity for ANGLE to secure the first ever FDA clearance for a platform that captures and harvests intact circulating tumor 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 - Adrian Hargrave, Simon Hicks, Max Bullen-Smith Corporate Broking - Alice Lane, Nikita Jain	[phone]
WG Partners (Joint Broker) Nigel Barnes, Nigel Birks, Andrew Craig, Chris Lee	[phone]
FTI Consulting Simon Conway, Mo Noonan, Stephanie Cuthbert Evan Smith, Anne Troy (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 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 Roche Cobas, was utilising ctDNA (fragments of dead cancer cells) to investigate the presence of a single gene, EGFR, as a companion diagnostic for one particular drug, Tarceva, 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.

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 for Europe 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 highly multiplexed, rapid and sensitive capture of targets from a wide variety of sample types.  A proprietary chemistry allows for the capture and amplification of over 100 biomarkers simultaneously in a single reaction.  These technologies can be combined to provide fully automated, sample to answer results in both centralised laboratory and point of use cartridge formats.  It is ideal for measuring gene expression and other markers directly from Parsortix harvests.

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/

 

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