Angle Regulatory News (AGL)

ANGLE plc ("the Company")

ANGLE REPORTS SUCCESSFUL HEADLINE DATA IN US AND EUROPEANOVARIAN CANCER STUDIES IN 400 PATIENTS

Parsortix blood test demonstrates potential to out-perform current standard of care in identifying ovarian cancer

ANGLE moves into validation phase of development for its first clinical application

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce positive headline results from 400 patient pelvic mass studies, in the US and Europe, demonstrating the potential for a Parsortix based blood test to out-perform current tests in discriminating between benign and malignant pelvic masses.

Evaluation of data from both ANGLE's European study (ANG-001) led by Dr Robert Zeillinger at the Medical University of Vienna and ANGLE's US study (ANG-003) led by Dr Richard Moore at the University of Rochester Medical Center, Wilmot Cancer Institute (New York State) shows that a test using the Parsortix system can differentiate between women with a malignant pelvic mass and those with benign tumours with a high degree of sensitivity (correctly identifying cancer) of up to 95% whilst at the same time achieving a higher specificity (low false positive rate) than existing tests.

The Parsortix test combines both high sensitivity and high specificity. Compared to CA125 for the ANG-003 samples, at a high sensitivity the Parsortix result had nearly double the specificity of the CA125 result.

These study results infer that best performance can be achieved when combining selected gene information analysed from the Parsortix harvest in an algorithm with certain patient condition information. The algorithm, which is proprietary, will be further optimised to give the best performance in the upcoming validation study. It is expected that it will be possible to apply for patent protection on the details of the algorithm strengthening ANGLE's competitive positive further. Therefore, full details of the analyses are being restricted until this process is complete. The cancer centres involved will then publish the full results of the studies in leading peer-reviewed publications.

ANGLE's Parsortix blood test has the potential to assist in the diagnosis of ovarian cancer prior to a patient undergoing a biopsy or surgery. This will enable women with ovarian cancer to be referred to gynaecologic oncology surgeons and institutions that specialise in the care of women with ovarian cancer, giving them the best possible outcome for the treatment of their disease. At the same time, it will allow patients with a benign tumour to be cared for in their communities. This has the potential to reduce healthcare costs and avoid the unnecessary transfer of patients from their local hospital to specialist referral centres. The test also has the potential to identify targets on the tumour that may be used to inform treatment strategies.

The test is RNA-based and cannot be undertaken with ctDNA techniques.

Professor Robert Zeillinger, Head of the Molecular Oncology Group at the Department of Obstetrics and Gynaecology, Medical University of Vienna, commented:

"The 200 patient ANG-001 clinical multi-centre study has shown that the Parsortix based test allows us to successfully discriminate patients with ovarian cancer from patients with a non-malignant pelvic mass with a high degree of accuracy. Using ANGLE's Parsortix system and a panel of RNA markers, there is the prospect that we can meet a key medical need in triaging women before surgery to ensure patients with cancer get the care they need."

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

"The 200 patient ANG-003 clinical study shows that the Parsortix test has the ability to accurately discriminate malignant from benign pelvic masses prior to biopsy or surgery. The test also offers key additional benefits over existing practice through the gene expression information it provides, which may help to further guide choices for targeted therapy in women with ovarian cancer. Additionally, the test may allow separate identification of patients with low malignant potential and/or other cancer types using a non-invasive liquid biopsy test."

Both Professor Zeillinger and Dr. Moore stated that: "The pilot trials offer exciting new data supporting the Parsortix technology and its continued development moving towards validation trials."

The successful results announced today enable ANGLE to move into the next phase of development of a commercial blood test addressing an estimated market size of £300 million per annum. Firstly, the test will be optimised to maximise performance. Some key aspects of the downstream analysis techniques have been identified that ANGLE believes can be enhanced to improve the performance of the assay and provide an even stronger competitive advantage. The performance of the optimised test will be confirmed utilising a second blood sample that has been banked from each of the ANG-003 study patients.

The performance of the optimised test will then be validated in a separate set of patients through the conduct of appropriately powered validation studies designed to meet European CE Mark and US FDA regulatory requirements. Successful completion of these validation studies will allow the commercial sale of the Parsortix based pelvic mass test in the United States and Europe, and eventually worldwide.

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"ANGLE's first large scale clinical studies of 400 patients have demonstrated positive results with the potential to out-perform current standard of care. This success enables ANGLE to move forward into the validation phase for the use of Parsortix in its first clinical application. We believe ANGLE is building momentum towards securing a leading and well differentiated commercial position in the emerging multi-billion dollar liquid biopsy market."

For further information:

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

About ANGLE plc www.angleplc.com

ANGLE is a world-leading liquid biopsy company commercialising a disruptive platform technology that can capture cells circulating in blood, such as cancer cells, even when they are as rare in number as one cell in one billion blood cells, and harvest the cells for analysis.

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. Parsortix is the subject of granted patents in Europe, the United States, Canada, 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. Parsortix has a CE Mark for Europe and FDA authorisation is in process for the United States.

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/ 

The analysis of the cells that can be harvested from patient blood with ANGLE's Parsortix system has the potential to help deliver personalised cancer care offering profound improvements in clinical and health economic outcomes in the treatment and diagnosis of various forms of cancer.

The global increase in cancer to a 1 in 3 lifetime incidence is set to drive a multi-billion dollar clinical market. The Parsortix system is designed to be compatible with existing major medtech analytical platforms and to act as a companion diagnostic for major pharma in helping to identify patients that will benefit from a particular drug and then monitoring the drug's effectiveness.

As well as cancer, the Parsortix technology has the potential for deployment with several other important cell types in the future.

ANGLE stock trades on the AIM market of the London Stock Exchange under the ticker symbol AGL and in New York on the OTC-QX under the ticker symbol ANPCY. For further information please visit: www.angleplc.com