ANGLE plc has signed a master clinical study agreement with Solaris Health Holdings, LLC and join agreements with MidLantic Urology LLC, to collaborate and conduct clinical studies in prostate cancer and as a potential route to commercialization in the United States. United

Alongside MidLantic Urology, a subsidiary of Solaris, ANGLE, headquartered in the United Kingdom, will launch clinical studies aimed at detecting prostate cancer and predicting its severity in patients who have a high level of specific antigen prostate cancer (PSA) and/or an abnormal digital rectal examination. The studies will use ANGLE’s Parsortix System, a circulating tumor cell (CTC) harvesting technology.

The design of the first study to be conducted with MidLantic Urology, which is expected to launch in Q3 2022, was aided by previous pilot studies at the Barts Cancer Institute (Queen Mary University London), which used the Parsortix system to harvest CTCs .

This study will initially enroll 100 men to undergo prostate tissue biopsy at at least three study sites over an expected period of up to nine months. Blood samples collected by MidLantic Urology will be shipped to ANGLE’s US clinical laboratory for processing through the Parsortix system to harvest and analyze CTCs and associated immune cells.

These will be evaluated by both imaging and molecular analysis to assess the potential to predict the presence of clinically significant prostate cancer prior to tissue biopsy and to assess the potential correlation with established disease severity scores in patients with prostate cancer.

ANGLE said it expects results in 2023. He added that the data could form the basis of a lab-developed test, and Solaris could be ANGLE’s first path to market for this test, offering the established test. to its patient base. Positive results could also allow for the design of a larger validation study to support eventual submission to the US Food and Drug Administration (FDA) and other regulatory agencies.

Prostate cancer

Prostate cancer is the leading cause of cancer in men and accounts for 13% of all new cancer cases in the United States. As part of the National Screening Program, 11 million men will undergo a PSA test in the United States each year. Of these, some 1.2 million will have an abnormal result, leading to further investigations.

The current standard of care, transrectal or transperitoneal biopsy of prostate tissue, is an invasive procedure associated with significant clinical complications and cost. Following the intervention, 32% of patients experience moderate side effects, and 1.4% of patients experience major complications. This includes post-biopsy sepsis in 2-5% of cases, with up to 25% requiring ICU admission at an estimated cost of $19,000 per patient.

Prostate tissue biopsies are negative in 75% of patients and put patients at unnecessary risk, but can also miss cancer in 30-40% of cases, requiring patients to undergo repeat tissue biopsy. At least 60% of prostate cancers diagnosed are unlikely to cause harm during a patient’s lifetime. However, many men undergo radical prostatectomy, which can be associated with postoperative complications, including urinary incontinence and erectile dysfunction.

According to ANGLE, liquid biopsy offers the possibility of safer and more cost-effective diagnosis, active surveillance where appropriate, and, after diagnosis, the possibility of offering targeted monitoring and treatment selection.

Dr. Jose Moreno, Principal Investigator at MidLantic Urology, said: “Even though PSA is a valuable marker of response to prostate cancer treatment, its role in screening is modest at best and can lead to both overdiagnosis of clinically indolent prostate cancer and underdiagnosis of clinically significant prostate cancer, which can lead to increased rates of local failure and metastatic disease.

He added, “ANGLE’s Parsortix platform has the potential to enable molecular characterization of cancer using a blood test in patients undergoing both traditional ultrasound biopsies and MRI fusion biopsies. Preliminary data suggests that we may be able to create a clinically meaningful prostate cancer test that has high specificity and sensitivity.

“Furthermore, the test can be customized to work in a wide range of prostate cancer disease states, including pre-prostatic biopsy, after negative biopsy, active surveillance, after local failure and in states early and late metastatic pathologies. If our results are validated, our patients at MidLantic Urology and our affiliates at Solaris Health could be the first to benefit from these developments.

ANGLE founder and chief executive Andrew Newland added that the successful development of the blood test could prevent men from being subjected to unnecessary tissue biopsies when they don’t have prostate cancer (despite the level elevated PSA) or that their cancer is indolent and unlikely. affect either their life expectancy or their quality of life.

“Funding for this study, which addresses a major unmet medical need, was a key part of our fundraising last year and could open up a significant market opportunity for ANGLE,” said Newland. “The launch of the study, expected in the near future, marks another commercial milestone as we develop our commercial plans for the Parsortix system.”