First patient enrolled in FDA study

RNS Number : 8764J

Angle PLC

05 April 2018

 

For immediate release

5 April 2018

ANGLE plc ("the Company")

FIRST PATIENT ENROLLED IN CLINICAL STUDY TO SUPPORT FDA CLEARANCE OF THE PARSORTIX SYSTEM

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

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce that the first patient has been enrolled into its ANG-002 FDA clinical study for metastatic breast cancer.  ANGLE is seeking to become the first ever company to receive FDA Class II clearance for a product for harvesting intact circulating tumor cells (CTCs) from patient blood for subsequent analysis¹.

The successful start of this study is the culmination of an enormous amount of work to develop, test and finalise the protocols involved and secure all of the necessary approvals for the clinical study.  There were significant technical issues that had to be addressed in relation to the downstream analysis techniques.  Optimisation of the techniques used to analyse cells harvested by the Parsortix^TM system has required the development of know-how which, now successfully completed, adds to the overall capability and differentiation of the Parsortix system in the market. 

FDA clearance is the de facto global gold standard for in vitro diagnostic tests as well as a legal requirement for sale of the product for the intended clinical use in the United States.  Securing FDA clearance has the potential to differentiate ANGLE in the liquid biopsy market, validating the clinical and analytical performance of the system and thereby positively influencing Parsortix system adoption worldwide.   

The clinical study involves recruitment of 200 metastatic breast cancer patients and 200 healthy volunteers enrolled at leading US cancer centres and is designed to support potential clearance by the FDA for the following intended use:

"The Parsortix^TM PC1 instrument is an in vitro diagnostic device intended to harvest circulating tumor cells (CTCs) from the peripheral blood of patients diagnosed with metastatic breast cancer.  Harvested CTCs can be used in subsequent analyses."

The primary endpoint of the clinical study, being led by MD Anderson, is the cytological evaluation of harvested cells confirming that CTCs are harvested from metastatic breast cancer patients but not from healthy volunteers.

The exploratory endpoints are to demonstrate that, in addition to the cytological evaluation, the Parsortix harvested cells can be analysed using quantitative PCR (qPCR, MD Anderson), fluorescence in situ hybridisation (FISH, University of Southern California) and whole transcriptome sequencing (RNA-Seq, University of Southern California).  As announced on 6 February 2018, ANGLE has signed an agreement with the global healthcare company Abbott to use its proprietary PathVysion HER-2 DNA FISH Probe kits in the study.  Abbott is the global market leader for FISH testing in solid tissue biopsies.  A positive result in this clinical study would demonstrate the potential for Abbott to offer a Parsortix-based product for HER-2 analysis from a routine blood test.

The enrolment of the patients and healthy volunteers are under the direct control of the independent cancer centres and outside the control of the Company.  Once the rate of enrolment and general progress of the clinical study becomes clear we will update the market on likely timescales. Current expectations continue to be that both the clinical study and the associated analytical studies will complete in H2 CY 2018. 

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"We believe there is a tremendous opportunity for ANGLE to secure the first ever FDA Class II clearance for harvesting 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.  The FDA clearance process is highly technically challenging.  ANGLE has successfully met the many challenges involved in establishing the study and we are now into the next stage of executing the clinical study.  We look forward to reporting further progress in due course."

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, Kate Bannatyne 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 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 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 based on harvesting 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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