Oxford Biodyn Regulatory News (OBD)

19 March 2019

Oxford BioDynamics Plc

("OBD" or the "Company" and, together with its subsidiaries, the "Group")

Oxford BioDynamics joins Imperial College London in a trial evaluating novel methods of screening for prostate cancer

· Diagnosis of prostate cancer at a curable stage is currently challenging

· The PROSTAGRAM trial, funded by Wellcome Trust, The Urology Foundation (TUF) and The British Medical Association (BMA), aims to assess the role of diagnostic approaches for prostate cancer screening

· Agreement signed with Imperial College London for prospective evaluation of participants with an established signature of EpiSwitch™ biomarkers for prostate cancer diagnosis

Oxford BioDynamics Plc announces that it has signed an agreement with Imperial College London to utilise its latest EpiSwitch™ biomarker signature for the blood-based diagnosis of prostate cancer in the PROSTAGRAM trial (Prostate Cancer Screening Trial Using a Group of Radiological Approaches Including MRI and Ultrasound), led by Professor Hashim Ahmed, Professor and Chair of Urology at Imperial College London and funded by the Wellcome Trust, TUF and BMA. The aim of the PROSTAGRAM trial is to assess the role of a number of diagnostic approaches, including magnetic resonance imaging (MRI) and multiparametric ultrasound to screen for prostate cancer.

Under the terms of the agreement, OBD will evaluate the participants enrolled in the study for prostate cancer, with its EpiSwitch™ proprietary diagnostic biomarker assay. OBD's assay for prostate cancer is based on six epigenetic systemic blood-based markers and was developed in collaboration with Mr Mathias Winkler, Consultant Urological Surgeon at Charing Cross Hospital, Imperial College Healthcare NHS Trust; and Professor Dmitry Pshezhetskiy, Norwich Medical School, University of East Anglia.

The assay has been developed across several cohorts of over 290 patients, with varying disease stages. It has demonstrated consistent sensitivity and specificity of >80% in three blinded validations. In its latest format, performed in MIQE-compliant real-time PCR readouts on blood, the test demonstrated 90% sensitivity and 85% specificity, with a positive predictive value of 90%.

Prostate cancer remains one of the most common causes of cancer death in men, with over 11,000 deaths in UK per year.1 The life time risk of death from prostate cancer in the UK is 4.3%, with mortality rates consistently higher than breast cancer mortality.2 The introduction of a viable population-based screening programme for prostate cancer has been a long-standing consideration.

Currently, diagnosis for prostate cancer remains challenging. Current clinical practice involves testing Prostate-Specific Antigen (PSA) levels in the blood. However, the UK National Screening Committee recommends against a universal screening programme due to the limitations of PSA as a screening test, which it describes as a "poor test for prostate cancer". In fact, there is no country or international body that recommends routine PSA screening for all men. The PSA blood test has been reported by independent studies to demonstrate sensitivities and specificities within the range of 32 and 68%.

The PROSTAGRAM trial has initiated enrolment and plans to recruit 406 male participants, aged 50 to 69 years old. The recruitment period is expected to last 24 months.

Alexandre Akoulitchev, Chief Scientific Officer of Oxford BioDynamics, said:

"Participation in this important trial into prostate cancer is a significant milestone for Oxford BioDynamics. We are looking forward to contributing our EpiSwitch™ blood-based readouts to the comprehensive evaluation of these trial participants. We are delighted to join forces with a team of world-leading experts in prostate cancer, and looking forward to potentially improving the detection of prostate cancer at a curable stage by aiding in the development of prostate cancer screening programme."

Professor Hashim Ahmed, Chair of Urology at Imperial College London and Chief Investigator, said:

"We look forward to this collaboration with Oxford BioDynamics, there is an urgent need to identify an alternative circulating prostate cancer marker and EpiSwitch™ has great potential."

Mr Mathias Winkler, Consultant Urological Surgeon, Charing Cross Hospital, Imperial College Healthcare NHS Trust, and Co-investigator, added: 

"Following on from our previous collaboration in the development phase for this unique prostate cancer signature we are delighted to explore its potential in a clinical study. Epigenetic information is not yet exploited in prostate cancer management and has the potential to add information on the lethality of cancer at the point of diagnosis."

References

1 Cancer Research UK. Prostate cancer statistics. 2016. https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/prostate-cancer 

2 Lloyd T, Hounsome L, Mehay A, Mee S, Verne J, Cooper A. Lifetime risk of being diagnosed with, or dying from, prostate cancer by major ethnic group in England 2008-2010. BMC Medicine 2015;13:171.

-ENDS-

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Notes for Editors

About Oxford BioDynamics Plc

Oxford BioDynamics Plc (AIM: OBD) ("Oxford BioDynamics") is a biotechnology company focused on the discovery and development of epigenetic biomarkers for use within the pharmaceutical and biotechnology industry.

The Company's award-winning, proprietary technology platform, EpiSwitch™, aims to accelerate the drug discovery and development process, improve the success rate of therapeutic product development and take advantage of the increasing importance of personalised medicine.

In particular, EpiSwitch™ can reduce time to market, failure rates and the costs at every stage of drug discovery. Additionally, the technology provides significant insights into disease mechanisms for drug discovery and product re‐positioning programmes and enables the personalisation of therapeutics for patients in the context of challenging pricing environments where improved clinical outcomes are critical.

Oxford BioDynamics is headquartered in the UK, and listed on the London Stock Exchange's AIM under the ticker "OBD". For more information please visit www.oxfordbiodynamics.com.