Angle Regulatory News (AGL)

ANGLE plc ("the Company")

USE OF PARSORTIX IN GANNET53 DRUG TRIAL IN OVARIAN CANCER

Over 400 blood samples already processed from 136 ovarian cancer patients

ANGLE plc (AIM:AGL OTCQX:ANPCY), the specialist medtech company, is delighted to announce that its Parsortix system has been formally adopted in the ongoing European wide GANNET53 drug trial, an ovarian cancer study.

GANNET53 is a large scale FP7 research project funded by the European Commission investigating use of the drug Ganetespib in metastatic, p53 mutant, platinum-resistant ovarian cancer. The project started in October 2013 and runs for 5.5 years with a budget of €6 million. The molecular results in relation to GANNET53 outcomes will be available at the end of the trial in 2019. More details about the trial are given below.

The Medical University of Vienna, under the leadership of Professor Robert Zeillinger is responsible for the Companion Diagnostics part of the trial, which stipulates that "CTC analysis before and during experimental therapy will be performed and evaluated for its value to monitor responsiveness to Ganetespib". The Medical University of Vienna team has worked for many years with a wide range of CTC systems, both those commercially available from ANGLE's competitors and new technologies under development including commercial and academic systems. Due to lack of suitable cell surface markers, antibody-based CTC systems are ineffective for ovarian cancer. The best result that has been obtained to date with other non-antibody based systems is a CTC detection sensitivity level of 24.5% (i.e. capturing CTCs from only one quarter of ovarian cancer patients).

Following the Medical University of Vienna's results with ANGLE's Parsortix system showing "unprecedented sensitivity and specificity" announced on 27 January 2015, ANGLE were invited by the consortium to participate in the study. The Medical University of Vienna commenced testing of GANNET53 blood samples for CTCs using Parsortix in May 2015. ANGLE's participation is through the provision of Parsortix loan instruments and cassettes.

The key objectives for ANGLE's participation in the trial are to (i) to obtain evidence of the capability of the Parsortix system to harvest cancer cells from patient blood for analysis in large scale studies to support sales of the system into other drug trials and (ii) with regard to this specific trial, the possibility that, if the GANNET53 trial is successful, the Parsortix might subsequently be utilised as a companion diagnostic to identify patient responders for Ganetespib.

Formal contractual processes involving the GANNET53 project partners and the European Commission have been protracted given the large number of partners involved and have just been completed. The initial performance of the Parsortix system can now be reported. The GANNET53 results so far are that:

· 424 blood samples have been collected from 136 patients. All these samples have been processed using Parsortix.

· Molecular analysis of 136 of the Parsortix harvests has so far been performed in relation to those patients that have finished therapy. The remaining Parsortix harvests have been stored and analysis will be undertaken at a later date.

· In 134 of 136 Parsortix harvests so far analysed, sufficient RNA could be isolated for further qPCR analysis.

· The Medical University of Vienna are in the process of analysing the RNA markers found in the Parsortix harvests to determine their presence or absence. The study is blinded so correlation of the results with the patient response or otherwise to the drug has not yet been evaluated.

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

"For the first time, using the Parsortix system, we can now reliably access ovarian cancer cells from patient blood samples for analysis. This opens up completely new approaches to drug development in ovarian cancer and has the potential for wide applicability in other ovarian cancer drug trials."

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"The integration of our system into drug trials is a key objective in order to grow research use sales. Today's news follows Cancer Research UK Manchester Institute's recent incorporation of Parsortix for routine use in their clinical trials. Performance demonstrated in the GANNET53 trial and the capability developed by Medical University of Vienna to analyse the cancer cells has the potential to open new markets for Parsortix."

For further information:

For Frequently Used Terms, please see the Company's website on http://www.angleplc.com/the-parsortix-system/glossary/

Notes for editors

About GANNET53 http://www.gannet53.eu 

GANNET53 is a large scale FP7 research project funded by the European Commission investigating use of the drug Ganetespib in metastatic, p53 mutant, platinum-resistant ovarian cancer. The project started in October 2013 and runs for 5.5 years with a budget of €6 million.

The project is coordinated by Professor Nicole Concin from the Innsbruck Medical University, Austria. Project partners include major cancer centres from Austria, Belgium, France and Germany:

· Medizinische Universität Innsbruck - Austria

· Katholieke Universiteit Leuven - Belgium

· Charité - Universitätsmedizin Berlin - Germany

· Universitätsklinikum Hamburg-Eppendorf - Germany

· Medizinische Universität Wien - Austria

· Assistance Publique - Hôpitaux de Paris - France

· Centre Anticancereux Léon Bérard, Lyon - France

· AGO Research GmbH - Germany

· Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie - Germany

· Association de Recherche dans le Cancers dont Gynécologique - Groupe des Investigateurs Nationaux dans l'Etude des Cancers Ovariens (ARCAGY-GINECO), Paris, France

· Universitätsmedizin Goettingen - Germany

· OncoLab Diagnostics GmbH - Austria

· xailabs GmbH - Germany

· Klinik Essen-Mitte, Evang. Huyssens-Stiftung/ Knappschaft gemeinnützige GmbH - Germany

· Technische Universität Dresden University Hospital Carl Gustav Carus Dresden - Germany

· Centre de lutte contre le cancer, Francois Baclesse, Caen CFB France

· Ernst-Moritz-Arndt-Universität Greifswald - Germany

· Otto-von-Guericke-Universität Magdeburg - Germany

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 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