r-STRAT-PRO: Risk STRATification of PROstate cancer patients using novel rapid Leukocyte ImmunoTest™ blood test

"Prostate cancer is the most common cancer in European males, with over 340,000 new cases and 71,000 deaths each year in the EU. Indeed, experts predict up to 1 in 8 men in the EU will be diagnosed with prostate cancer during their lifetime. Significant progress has been made in recent years in detecting the onset of prostate cancer. In particular, prostate-specific antigen (PSA) from blood tests has been found to be a useful marker of prostate disease; however, a number of studies have shown that it often results in ""false positives"" that can lead to worry and anxiety among patients. Therefore, a need exists for new tools to rapidly classify patients based on likely disease severity, to monitor disease progression and to enable the development of home monitoring kits for monitoring disease progression and recurrence.

To address this unmet clinical need, Oxford MediStress (OMS) has developed the Leukocyte ImmunoTest(tm) (LIT(tm)) for rapidly assessing neutrophil function, a key aspect of the immune system. The rapid, portable, hand-held point-of-care (POC) test analyses a pinprick of blood and quantitatively evaluates how well an individual's white blood cells (their so-called ""neutrophils"") are capable of responding to chemical ""stimulation"" in a test tube when mixed with our patented chemicals. The test has been successfully evaluated recently in a clinical trial involving prostate cancer patients in London to see if the ten-minute test could pick out which patients had the most severe disease. According to our collaborating cancer experts, these results provide confidence the test could one day act as a risk stratification method and as a method to monitor disease progression in prostate and other cancers, including breast cancer.

The outputs of the proposed feasibility study will increase our understanding of how the test can be used in current clinical practice for risk stratification and disease monitoring in prostate cancer and to see whether it could be used in other areas of prostate cancer monitoring, as well as in other cancers. Finally, the project will improve our understanding of the clinical-regulatory and manufacturing strategies that the Company will need to adopt to be successful and, at the same time, benefit the patient and healthcare-provider."