Ovarian cancer study patient enrolment completed

RNS Number : 5077W

Angle PLC

26 April 2021

 

For immediate release

26 April 2021

ANGLE plc ("the Company")

PATIENT ENROLMENT COMPLETED IN OVARIAN CANCER CLINICAL VERIFICATION STUDY

Headline results from the Study expected in Q4 2021

Study designed to support launch of an ovarian cancer test from ANGLE's clinical laboratories in the United States and the UK

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is pleased to announce that its 200 patient ovarian cancer clinical verification study ("the Study") has completed patient enrolment.

The Study, undertaken by the University of Rochester Medical Center Wilmot Cancer Institute, New York, USA (URMC), is designed to evaluate the use of ANGLE's Parsortix^® system for circulating tumour cell (CTC) harvest and subsequent downstream analysis with ANGLE's HyCEAD™ multiplex RNA platform as a simple blood test to detect the presence of ovarian cancer in women with a pelvic mass prior to surgery.

The performance of ANGLE's predictive ovarian cancer detection assay, which achieved an AUC-ROC¹ >95% in a previous 200 patient study performed by ANGLE, is being evaluated in a new patient cohort.  It is anticipated that the remaining patients' surgical procedures, clinical status determinations and clinical database inputs will be finalised and 'locked' (kept secure and inaccessible until sample evaluation is completed) by the end of Q2 2021. The clinical status of the new patient cohort will be kept blinded until after the molecular analysis of the Study samples is performed. The HyCEAD molecular analysis of the Parsortix processed samples is expected to take place in Q3 2021 with the Study reporting headline results in Q4 2021.

Once the new performance data is available, and assuming positive results, ANGLE intends to establish this test as a laboratory developed test (LDT) for discriminating malignant from benign pelvic masses prior to surgery. ANGLE expects this to be the first molecular LDT to become available in its recently established clinical laboratories, once necessary accreditations have been achieved, around the end of this year.

The test has the potential to significantly improve patient outcomes, whilst also reducing overall healthcare costs.

Approximately 5% to 10% of women will be diagnosed with an ovarian cyst or pelvic mass during their lifetime and, in the United States alone, more than 200,000 women undergo surgery for pelvic mass each year. Although commonly benign, up to 12% of patients who undergo surgery will subsequently be diagnosed, post surgery, with ovarian cancer. Current diagnosis of ovarian cancer ahead of surgery is unreliable with both high false positive results and high false negative results, as it utilises ultrasound imaging and the measurement of CA-125 protein in blood. Imaging is imprecise and CA-125 protein is a non-specific analyte (it can be upregulated for reasons other than cancer).

As such, in patients indicated for surgery for an ovarian cyst or pelvic mass, there is a key unmet medical need to accurately determine, ahead of surgery, whether cancer is present. An accurate diagnosis would enable patients to be triaged to specialist cancer surgeons, where malignancy is probable. Cancer patient outcomes are significantly worse when surgery is not undertaken by a specialist cancer surgeon and the pelvic mass is malignant rather than benign.

With validation, there is also the potential for use of the ovarian cancer test to extend beyond the initial intended use of pelvic mass surgery triage to include conservative management (watchful waiting) to avoid a surgery for pelvic mass where malignancy is not suspected, monitoring of ovarian cancer patients after treatment, and molecular evaluation of the tumour to aid in drug selection. ANGLE estimates that the total addressable market for this test is up to US $1.8 billion per annum in the United States alone.

Dr Richard Moore, Director of the Gynecologic Oncology Division, University of Rochester Medical Center, Wilmot Cancer Institute commented:

"This 200-patient study is designed to verify the clinical performance of the novel ANGLE ovarian cancer assay in discriminating malignant from benign pelvic masses prior to surgery through a simple blood test. The test's high sensitivity and specificity, if verified, will help to ensure that women with ovarian cancer get the best possible treatment whilst women with a benign condition will be able to have their treatment locally with the physicians they know."

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"Completion of patient enrolment is a key step in this pivotal study towards demonstrating the capability of a Parsortix-based blood test to accurately detect the presence of ovarian cancer. Subject to the test performing as expected and securing the necessary accreditations of the Company's clinical laboratories to run molecular assays, the timing of which is outside our direct control, we are targeting launch of this test around the end of the calendar year."

For further information ANGLE:

ANGLE plc	[phone]
Andrew Newland, Chief Executive Ian Griffiths, Finance Director Andrew Holder, Head of Investor Relations
finnCap Ltd (NOMAD and Joint Broker) Corporate Finance - Carl Holmes, Simon Hicks, Teddy Whiley ECM - Alice Lane, Sunila de Silva	[phone]
WG Partners (Joint Broker) Nigel Barnes, Nigel Birks, Andrew Craig	[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 https://angleplc.com/investor-relations/glossary/

Notes for editors

1.  The area under the curve (AUC) for a receiver operating characteristic (ROC) plot, a plot of 1-specificity on the x-axis vs. the sensitivity on the y-axis at each possible threshold for a test's results, is a measure of a diagnostic test's accuracy. The accuracy of the test depends on how well the test separates the two groups being compared into those with the outcome (sensitivity) and those without the outcome (specificity) in question. An AUC of 1 (100%) represents a perfect test while an AUC of 0.5 (50%) represents a worthless test. The traditional academic classification system for ROC-AUCs is 90% to 100% = excellent; 80% to 90% = good; 70% to 80% = fair; 60% to 70% = poor; 50% to 60% = fail. Source: University of Cambridge MRC Unit http://imaging.mrc-cbu.cam.ac.uk/statswiki/FAQ/roc

About Dr Richard Moore, Director of the Gynecologic Oncology Division, University of Rochester Medical Center, Wilmot Cancer Institute https://www.urmc.rochester.edu/people/29638888-richard-g-moore

Dr Moore came to UR Medicine from Brown University and Women & Infants Hospital of Rhode Island. A native of Montreal, Quebec, Canada, Dr Moore graduated from the University of Alberta Medical School in Edmonton. He completed his residency at Eastern Virginia Graduate School of Medicine, where he also served as Administrative Chief Resident. He completed a fellowship in Gynecologic Oncology and Breast Surgery at Women & Infants Hospital/Brown University. Dr Moore joined the faculty at Women and Infants/Brown University after leaving fellowship. He served as the Associate Director of the Program in Women's Oncology since and was the Director of the Center for Biomarkers and Emerging Technology as well as the Molecular Therapeutics laboratory.

Dr Moore is board-certified in gynecologic oncology and is a fellow of the American College of Obstetricians and Gynecologists and a fellow of the American College of Surgeons.

In addition to his clinical interest in ovarian and endometrial cancers, Dr Moore is recognized internationally as a leading expert on the use of biomarkers to detect ovarian cancer. He led the team that developed the Risk of Ovarian Malignancy Algorithm (ROMA), a test that is cleared for use in Europe and Asia and was cleared by the U.S. Food and Drug Administration to detect ovarian cancer in women who have an ovarian cyst or pelvic mass.

Dr Moore sees patients at 125 Lattimore Road, Suite 258 and performs surgeries at Highland Hospital, which has been awarded the Gold Seal of Approval by the Joint Commission and leads the state in the number of minimally invasive, robotic surgeries for gynecologic cancer performed each year.

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 an intact cell they allow DNA, RNA and protein analysis and may provide comparable analysis to a tissue biopsy. Because CTC analysis is a non-invasive process, unlike tissue biopsy, it can be repeated as often as needed. This is important because cancer develops and changes over time and there is a clear medical need for up-to-date information on the status of a patient's tumor. In addition, the live CTCs harvested by the Parsortix system can be cultured, which offers the potential for testing tumor response to drugs outside the patient. 

The Parsortix technology is the subject of 26 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, in the United States, a De Novo Submission has been made to FDA for the Parsortix^® PC1 system seeking FDA clearance with Class II Classification for use with metastatic breast cancer patients. FDA clearance is seen as the global standard. ANGLE is seeking to be the first ever FDA cleared system for harvesting CTCs for subsequent analysis.

ANGLE has also completed 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 (AUC-ROC) of 95.1%. The pelvic mass triage assay has undergone further refinement and optimisation and a 200 patient clinical verification study has now completed enrolment.

ANGLE's technology for the multiplex evaluation of proteins and nucleic acids of all types is called the HyCEAD^TM 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 (AUC-ROC) 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 41 peer-reviewed publications and numerous publicly available posters, available on our website.

ANGLE's has established clinical services laboratories in the UK and USA to accelerate commercialisation of the Parsortix system and act as demonstrators to support product development. The laboratories offer services to pharmaceutical and biotech customers for use of Parsortix in cancer drug trials and, once the laboratories are accredited and tests validated, will provide Laboratory Developed Tests (LDTs) for patient management.

 

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