Angle Regulatory News (AGL)

ANGLE plc ("the Company")

RESEARCH GRANT FROM ABBOTT

Abbott PathVysion HER-2 DNA Probe assay to be used in ANGLE FDA Study

ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce that it has signed an agreement with global healthcare company Abbott in which Abbott will supply ANGLE with its proprietary PathVysionTM HER-2 DNA FISH Probe kits for ANGLE's ANG-002 FDA study for FISH (fluorescence in situ hybridization) analysis of circulating tumor cells (CTCs) in the form of a research grant.

FISH analysis, which is a form of investigation of the cancer cells used with solid tissue biopsy to help select treatment, is one of the exploratory end-points for ANGLE's FDA study in metastatic breast cancer. The objective of this end-point is to demonstrate that CTCs can be harvested from the blood of metastatic breast cancer patients using the ParsortixTM system and that the harvested CTCs can then be subjected to FISH analysis to determine their HER-2 status.

Abbott's PathVysion HER-2 DNA FISH Probe Kit (PathVysion) is one of the first examples of what is recognised as genomic disease management (or personalised medicine). Physicians use the PathVysion HER-2 result to help determine which patients may be the best candidates for personalised therapy. Specifically, PathVysion accurately determines HER-2 gene status, identifying which patients are HER-2 positive. About 1 in every 5 breast cancer patients have a positive HER-2 result and for these women, it means they are more likely to respond to Herceptin® therapy. Herceptin can help control the growth of cancer cells that contain high amounts of HER-2 (human epidermal growth factor receptor 2). Herceptin works by blocking the effects of HER-2 and encouraging the immune system (the body's natural defences) to attack and kill the cancer cells. 

Abbott's PathVysion was released in 1998 and was the first gene-based test approved (2001) by the FDA for determining HER-2 status. Abbott remains the global market leader for FISH testing in solid tissue biopsies. A positive PathVysion HER-2 result in Parsortix harvested CTCs would demonstrate feasibility of evaluating use of the assay in a breast cancer liquid biopsy in metastatic breast cancer patients. This would be a significant step toward advancing healthcare options for these patients, as it is not often possible to obtain solid tumor biopsy specimens in late stage cancer and the patient's HER-2 status can change with disease progression. Using blood as a surrogate could provide an avenue to new therapies and new hope for a very ill population.

Kathryn B Becker, PhD, Franchise Director Oncology and Companion Diagnostics, Abbott commented:

"Abbott is pleased to collaborate with ANGLE in this important evaluation of PathVysion in liquid biopsy specimens. The PathVysion HER-2 DNA FISH Probe kit is reliable and accurate in tissue biopsy samples and the Parsortix system may unlock the potential for PathVysion use in a simple blood test. We look forward to the outcomes of the study and the potential opportunity to further collaborate with ANGLE in combining FISH and liquid biopsy in other areas."

ANGLE's Founder and Chief Executive, Andrew Newland, added:

"This is another important collaboration for ANGLE with a leader in downstream analysis. Abbott's PathVysion is the market leader for FISH evaluation of HER-2 in breast cancer. Following our FDA studies, we hope to be able to work with Abbott to extend PathVysion use into routine blood test analysis as an important downstream application of the Parsortix system in breast cancer. Use of ANGLE's Parsortix system would for the first time enable established tissue biopsy techniques to be used for breast cancer on cancer cells obtained from a simple blood test protecting patients from invasive procedures and improving their care whilst at the same time reducing healthcare costs."

For further information ANGLE:

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 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 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, 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 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/ 

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 biomarker analysis platforms are adaptable to measure protein and nucleic acid biomarkers across the full spectrum of disease applications.

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

About Abbott www.abbott.com

Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 99,000 people.