ANGLE PLC

Environmental & Social Information • Sep 8, 2014

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RNS Number : 0190R

Angle PLC

08 September 2014

For immediate release	8 September 2014

ANGLE plc ("the Company")

COLLABORATION WITH THE UNIVERSITY MEDICAL CENTER

HAMBURG-EPPENDORF

ANGLE plc (AIM: AGL), the specialist medtech company, is pleased to announce it has signed a collaboration agreement with The University Medical Center Hamburg-Eppendorf (UKE), a world leader in circulating tumour cell (CTC) research and part of the University Cancer Center Hamburg.

Research in the UKE Department of Tumour Biology is dedicated to the identification and characterisation of tumour cells that have disseminated from the primary tumour and may give rise to overt metastases in cancer patients.

UKE is to collaborate with ANGLE in four main areas:

·     Comparison of the performance of the Parsortix system with the existing in-market product, using metastatic breast, bladder, colon and lung cancer patient samples

·     Development and optimisation of the Parsortix system and associated protocols with various downstream analysis techniques to provide a liquid biopsy solution

·     Molecular analysis of individual captured CTCs including DNA, RNA and protein analysis

·     Specific assessment of the Parsortix system's suitability to provide a HER2 liquid biopsy analysis.

Prior to entering into the collaboration agreement, UKE undertook a six month evaluation of ANGLE's Parsortix system. As well as working with spiked samples, this included clinical samples from a number of patients suffering from a range of cancers, including colorectal cancer, lung cancer, breast cancer, bladder cancer and head and neck cancer.

ANGLE is strongly focused on establishing the use of the Parsortix system in clinical practice.  To achieve this, the top priority is the establishment of collaborations with key opinion leaders at world class research 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.  We believe that we are on the right path to unlocking the multi-billion dollar market worldwide available to ANGLE and its potential strategic partners.

Professor Klaus Pantel, Director of Department of Tumour Biology at UKE, commented:

"We are very pleased to be working with ANGLE and their Parsortix system. Through our six month evaluation of the device we have seen that their size based approach to capture and harvest of circulating tumour cells has been shown to be effective across a range of cancer types. We look forward to building on the work we have undertaken."

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"Professor Pantel and his team have world-leading knowledge of CTCs and first hand experience of working with a range of CTC capture techniques. We are delighted that following their evaluation UKE are keen to undertake further work with the Parsortix system. We believe UKE will be at the forefront as CTCs move towards clinical application and will be an important key opinion leader for Parsortix."

For further information:

ANGLE plc	01483 685830
Andrew Newland, Chief Executive Ian Griffiths, Finance Director
Cenkos Securities Stephen Keys, Dr Christopher Golden (Nominated adviser) Andy Roberts, Christian Hobart (Sales)	020 7397 8900
Buchanan Mark Court, Fiona Henson, Sophie Cowles	020 7466 5000

University Medical Center Hamburg-Eppendorf (UKE)

The University Medical Center Hamburg-Eppendorf is the largest among Hamburg's hospitals with approximately 1,460 hospital beds. Each year the medical center treats around 80,000 in-patients. Additionally, approximately 260,000 out-patients as well as 113,000 emergency patients are treated.

Similar to most university hospitals, the UKE offers a complete range of treatment options for patients. At the same time, new ideas in research and new approaches for the diagnosis and therapy of diseases are applied. The range of medical care extends from overall diagnostic service to highly specialised and complex treatments necessary for uncommon diseases. For the Hamburg region, a large number of therapies and complicated surgical procedures, especially in the field of transplantation (heart, liver, kidney as well as bone marrow) can only be performed in the UKE.

All common diseases are treated. Furthermore, the UKE has more than 160 clinics for complex, rare and chronic syndromes - e.g. the treatment of muscle diseases, blood coagulatory disorders, heart rhythm disorders, impaired vision or obsessive-compulsive disorders. A wide range of diagnostic and therapeutic treatment options is available for metabolic diseases, allergies and neural diseases. Patients with complex diseases, cancer and other disorders requiring a comprehensive treatment benefit from the interdisciplinary cooperation within the UKE. A modern stroke unit with four patient beds provides optimal conditions after an acute stroke.

Endoscopic techniques, further developed and advanced within the UKE along with various other disciplines, have come to international recognition. The departments of radiology and neuroradiology offer a wide range of modern imaging techniques. Highly specialised laboratories and tissue analysis performed within the UKE departments complement the clinical diagnosis.

Explanation of Frequently Used Terms in connection with the Parsortix system

Term	Explanation
Biopsy	Process by which cancer cells are removed from the tumour for molecular analysis
Capture	Process for capturing target cells from sample
Capture efficiency	Proportion of target cells captured
CD45	The CD45 antibody recognises the human CD45 antigen, also known as the leukocyte common antigen.  WBC are CD45+ whereas CTCs are CD45-.  Staining with CD45 often used as a negative confirmation that CTCs are not WBC
Cell-free DNA	Genomic DNA found in the plasma
Cell labelling	Technique involving the staining of target cells with fluorescent and/or chromogenic markers for cell identification
Cell lines	Cultured cells
CE Mark	Regulatory authorisation for the sale of products for clinical use in the European Union
Circulating tumour cell	Cancer cell that is circulating in the patient blood
CTC	Circulating tumour cell
CTC labelling	CTCs are often labelled with three markers and are formally identified as CTCs if they are CK+, CD45-, DAPI+
CK	Cytokeratin
CK+	A cell positive for the presence of cytokeratin protein or mRNA with the presence of distinct cytokeratins often used to identify epithelial cells
Clinical application	Use in treating patients
Clinical samples	Patient samples usually blood
Clinical use	Use in treating patients
Cultured cells	Cultured cells grown in the laboratory from human-derived cells used for experimental work
Cytokeratin	Cytokeratins are family of intracytoplasmic cytoskeleton proteins with members  showing tissue specific expression
DAPI	A nuclear stain that is often used to identify the nucleus in a cell.
DEPArray™	A commercial single cell isolation system
DNA	Deoxyribonucleic acid (DNA) the molecule that encodes the genetic instructions used in the development and functioning of all known living organisms and many viruses
Downstream technologies	Technologies used to undertake molecular analysis of harvested cells after the separation has taken place
EGFR	The epidermal growth factor receptor a signalling molecule which is typically present on the cell surface and can cell activity including cell proliferation. Mutations in EGFR or deregulation have been associated with a number of cancers including ~30% of all epithelial cancers
Enrichment	Generic term for concentrating target cells or molecules in a starting heterogeneous mixture
EpCAM	The EpCAM protein is found spanning the membrane that surrounds epithelial cells, where it is involved in cell adhesion
EpCAM+ cells	Cells that express EpCAM.  CTCs can be either EpCAM+ or EpCAM-
Epithelial cells	Cells that line the surfaces and cavities of the body
Epithelial CTCs	CTCs that are epithelial often based on EpCAM+
Epithelial-mesenchymal transition	Process by which epithelial cells lose their cell polarity and cell-cell adhesion, and gain migratory and invasive properties to become mesenchymal cells. EMT is thought to occur as part of the initiation of metastasis and is often responsible for cancer progression
EMT	Epithelial-mesenchymal transition
FDA	U.S. Food and Drug Administration responsible for authorised medical products in the United States
FDA 510(k)	A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to Premarket Approval. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims
Genome	Genetic material of an organism. The genome includes both protein coding and non-coding sequences
Harvest	Process for recovering captured cells from the separation system to allow molecular analysis
Harvest efficiency	Proportion of target cells harvested
Harvest purity	The number of target cells (such as CTCs) in the harvest as a proportion of the WBC. The minimum purity from which downstream analysis is possible is 0.5%.  Analysis of one target cell therefore requires no more than 200 WBC be in the harvest
HER2	A member of the epidermal growth factor receptor (EGFR/ERBB) family. Amplification or overexpression of HER2 has been shown to play an important role in the development and progression of certain aggressive types of breast cancer. In recent years the protein has become an important biomarker and target of therapy for ~30% of breast cancer patients
HNV	Healthy normal volunteer
HT29	Cultured colorectal cancer cell line
In-cassette labelling or in-situ labelling	CTC labelling for cell identification undertaken inside the separation system
KRAS	A signalling molecule frequently mutated in the development of many cancers
Leukocytes	White blood cells
Liquid biopsy	Term used for the process of obtaining cancer cells (or cell-free DNA) from a blood sample.  Unlike solid biopsy, liquid biopsy is non-invasive and repeatable.
Mesenchymal CTCs	CTCs generally lacking epithelial markers with mesenchymal features
Metastasis	Spread of a cancer from one site to another
Molecular analysis	Analysis of DNA, RNA and protein often used to determine the mutational status of a patient
mRNA	Messenger RNA used to direct the synthesis of proteins
NSCLC	Non Small Cell Lung Cancer
Off-chip labelling	CTC labelling for cell identification of harvested cells undertaken outside the separation system
Paired samples	Two related samples often used to compare different systems
Personalised cancer care	Treating a patient individually based on their personal data often including mutational and disease status
Plasma	Pale-yellow liquid component of blood obtained following removal of cells
Pre-labelled cell lines	Cells which are labelled often with a fluorescent label to facilitate identification during analysis or enrichment
RNA	Ribonucleic acid performs multiple vital roles in the coding, decoding, regulation, and expression of genes. Together with DNA, RNA comprises the nucleic acids, which, along with proteins, constitute the three major macromolecules essential for all known forms of life
Separation	Term used for processing of a sample through the Parsortix system
Single cell analysis	Extraction of a single target cell from the harvest for analysis
Solid biopsy	Standard process for surgically excising (cutting out) cells from a solid tumour when that tumour is accessible.
Spiked cell experiments	Experiments where cultured cells are added (spiked) to HNV blood to assess the capture and harvest efficiency of the system
WBC	White blood cells
WGA	Whole genome amplification
Whole genome amplification	Method for amplification of an entire genome necessary for the picogram amounts of genomic DNA present in a single cell

This information is provided by RNS

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