Liquid biopsy company ANGLE has signed agreements with Solaris Health and its affiliate MidLantic Urology to conduct clinical studies in prostate cancer.
ANGLE and MidLantic Urology will begin clinical studies to evaluate the Parsortix system in prostate cancer.
The device is developed to detect the presence of prostate cancer and predict its severity in patients with an elevated prostate-specific antigen (PSA) level and/or abnormal digital rectal exam.
The first study design is expected to commence in the third quarter of the year and will draw on earlier pilot studies, which were independently conducted at the Barts Cancer Institute at Queen Mary University, London, UK.
Initially, 100 men at three study sites will be enrolled in the study and undergo a prostate tissue biopsy over an expected period of up to nine months.
MidLantic Urology will then ship the blood samples collected from the subjects to ANGLE’s US clinical laboratory for processing using the Parsortix system, which will analyse circulating tumour cells (CTCs) and associated immune cells.
ANGLE stated that the Parsortix harvests will be assessed by imaging and molecular analysis to check the potential to predict the presence of prostate cancer in the subject before the tissue biopsy.
It will also evaluate the potential correlation with established disease severity scores in patients who are found to have prostate cancer.
The headline data from the first study is expected next year.
ANGLE founder and CEO Andrew Newland said: “Successful development of this simple blood test could prevent men from being subjected to unnecessary tissue biopsies when they either do not have prostate cancer (despite the elevated level of PSA) or their cancer is indolent and unlikely to impact either their life expectancy or quality of life.
“The funding for this study, which addresses a major unmet medical need, was a key element of our capital raise last year and could open up a significant market opportunity for ANGLE.
“Initiation of the study, expected in the near future, delivers on another business milestone as we build out our commercial plans for the Parsortix system.”