Angle Regulatory News (AGL)

ANGLE plc ("the Company")

POSITIVE INTERIM EVALUATION OF OVARIAN CANCER CLINICAL STUDIES

Patient enrolment European study now over 90% complete and US study 70% complete

Headline data from the full studies expected in Q2, 2017

ANGLE plc (AIM:AGL OTCQX:ANPCY), the specialist medtech company, is delighted to announce the outcome from the planned interim evaluations of two separate 200 patient ovarian cancer studies, in Europe and the United States.

The early evaluation of data from both the studies suggest that an assay using the Parsortix system could accurately differentiate between women with a malignant pelvic mass and those with benign tumours, with an additional benefit of providing valuable gene expression information which could help further refine treatment decisions. Such data, if confirmed over the remaining samples, would represent an advantage over currently available clinical risk assessment tools.

The European study is being led by Dr Robert Zeillinger at the Medical University of Vienna and the US study is being led by Dr Richard Moore at the University of Rochester Medical Center, Wilmot Cancer Institute (New York State). An evaluation of data obtained from the first 50 patients enrolled in each study was undertaken, at the interim stage, in order to optimise the combination of RNA markers to detect malignancy.

The women in both studies had blood drawn prior to surgery for a diagnosed pelvic mass. The blood was processed through the Parsortix system to harvest, for evaluation, any circulating tumour cells (CTCs) that may have been present. The early evaluation of the data indicates that an RNA analysis of those cells harvested by the Parsortix system may enable the accurate and specific diagnosis of ovarian cancer in women with a pelvic mass.

Patient enrolment into the European study is now over 90% and is expected to be completed in February 2017. The US study patient enrolment is ahead of schedule with approximately 70% of the required patient sample enrolled and currently on target to be completed by the end of April 2017. Headline data from the full studies is expected to be available in Q2, 2017.

Ovarian cancer surgery is highly complex and informed decision making has a very strong impact on survival: women with a diagnosis or a strong indication of ovarian cancer are normally referred to a specialist gynaecologic oncology unit for surgery, while others will fall under the care of a local general surgeon or gynaecologist. Both clinical outcomes and costs are significantly impacted by having the right surgical team in place for the right procedure. It would therefore be of significant clinical benefit to know, in advance of surgery, whether an abnormal pelvic mass is malignant or benign. ANGLE estimates that the addressable global market for the pre-surgical assessment of ovarian cancer risk, could be in excess of £300 million per annum.

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

"The early data evaluation is encouraging. Using ANGLE's Parsortix system and a panel of RNA markers, there is the prospect 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 early data points are very promising and indicate that use of a multiplex RNA assay on harvested circulating tumour cells will help to accurately discriminate malignant from benign pelvic masses before surgery and at the same time provide valuable tumour specific genomic information that can help manage patients and their disease in a way that is not currently possible."

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"The interim data evaluation supports the potential for ANGLE's first clinical application to out-perform standard of care for the detection of ovarian cancer, particularly in relation to specificity avoiding false positives. Additionally there is an opportunity using Parsortix to obtain molecular information to guide therapy prior to surgery, which is not possible with existing approaches."

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 specialist medtech 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