GUILDFORD, UNITED KINGDOM--(Marketwired - Jul 19, 2016) -
ANGLE plc ("the Company")
INITIATION OF TWO HUNDRED PATIENT EUROPEAN OVARIAN CANCER STUDY
Four leading European cancer centres recruiting patients
Significant step towards obtaining CE-marked Parsortix-based test that distinguishes between a benign and malignant pelvic mass
ANGLE plc (AIM: AGL; OTCQX: ANPCY), the specialist medtech company, is pleased to announce that its European ovarian cancer study has been formally initiated and has recruited its first patient.
ANGLE has completed the complex and intensive process required to initiate this study. This process included optimising the system protocols for the application, developing and approving the study plan and the data collection and study documentation tools, obtaining ethics approval and contracting with leading cancer centres, and designing and delivering all the necessary forms, consumables and training required for the clinical study.
The four participating cancer centres, all of whom have been through formal study initiation and training and are actively recruiting patients, are:
- Medical University of Vienna, key opinion leader for ovarian cancer, leading the trial and responsible for analysing the patient samples and optimising the RNA markers;
- Charité - Universitätsmedizin Berlin, one of the largest university hospitals in Europe;
- Vivantes Network for Health GmbH with the Clinic for Gynecology and Obstetrical Medicine in the Klinikum Auguste Viktoria; and
- Vivantes Network for Health GmbH with the Department of Gynecology, Hospital Neukölln.
Based in Berlin, Vivantes Network for Health GmbH is the largest municipal hospital group in Germany, and the two clinics listed above are within their two largest hospitals.
The ovarian cancer study (known as ANG-001) is a 200 patient study, recruiting women diagnosed with a pelvic mass by imaging studies who are scheduled to receive surgery for the removal of their masses. Blood from consenting patients will be analysed using the Parsortix™ system and RNA from the cell harvests will be evaluated to detect the presence or absence of ovarian CTCs (circulating tumour cells). The aim is to discriminate successfully between women with benign and malignant masses as confirmed by the histopathological examination of the tissue post-surgery.
The first half of patients enrolled into the ANG-001 study will be used as a training set to determine which of the RNA markers previously investigated are optimal for the detection of ovarian cancer CTCs harvested by the Parsortix system. The remainder of the patients enrolled into the study will be used as a verification set to verify that these RNA markers are successful at discriminating between women with benign and malignant pelvic masses for pre-surgical triaging.
Whilst the speed of patient recruitment is outside of ANGLE's control, the aim is to complete the study by 2016 calendar year end.
Successful completion of the ANG-001 study would enable ANGLE to offer the Parsortix system to accredited European hospitals where a laboratory developed test (LDT) based on the RNA markers identified to assess the malignancy status of women prior to surgery for abnormal pelvic mass would be able to be designed. An LDT requires the hospital concerned to validate the test under their own quality control system. The centres conducting the trial are likely to be early adopters, leading to the potential for early revenues.
Based on the results of the ANG-001 study, ANGLE expects to design and conduct a further, appropriately powered, prospective clinical study to validate the clinical utility of the offering of Parsortix with the downstream RNA analysis. The successful validation would allow ANGLE to fulfil the In Vitro Diagnostic Directive (CE marking) requirements for the combined product so that all hospitals in Europe would be able to offer the test without having to validate it within their own quality control system.
ANGLE is also working on plans to execute a similar study in the United States.
Ovarian cancer surgery is highly complex and maximal tumour removal has a very strong impact on survival. Women with the diagnosis or a strong indication of ovarian cancer can be referred for surgery to specialists in gynaecologic oncology. The consequence is a significantly better outcome compared to the situation when surgery is performed by a general gynaecologist and cancer is diagnosed at this point. There would therefore be great clinical benefit if it were possible to know in advance of surgery if an abnormal pelvic mass is malignant. Conversely, women with benign pelvic mass may be more easily and cost effectively treated by a general surgeon in their local hospital. ANGLE estimates that the addressable global market for the pre-surgical assessment of ovarian cancer risk, available for Parsortix sales, could be in excess of £300 million per annum.
ANGLE Founder and Chief Executive, Andrew Newland, commented:
"It has been a huge effort to put this clinical study in place and we are now excited to see the study in progress. The four participating centres are enthusiastic and committed and we look forward to the next stage of development of this important clinical application."
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 Parsortix™ 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
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