ANGLE plc: SUCCESSFUL COMPLETION OF OVARIAN CANCER PRE-STUDY
Angle plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce that the first phase of its ovarian cancer clinical verification study (“the pre-study”) has reported positive results.
The pre-study, undertaken by Dr. Richard Moore and colleagues at the University of Rochester Medical Center Wilmot Cancer Institute (Rochester), was designed to evaluate the use of ANGLE's modified and further optimised ParsortixTM and HyCEADTM Ziplex® platforms as a simple blood test to detect the presence of ovarian cancer in women with a pelvic mass, in a clinical setting and with clinical samples.
The pre-study comprised the evaluation of blood samples from 26 Stage III/IV ovarian cancer patients and 28 healthy volunteers using ANGLE’s sample-to-answer molecular solution: Parsortix harvested circulating tumour cells and HyCEAD-Ziplex performed multiplex RNA expression analysis of those cells. The observed discrimination between cancer patients and healthy volunteers suggests the potential for both high sensitivity (correctly detecting cancer) and high specificity (correctly detecting no cancer i.e. low false positives).
The pre-study results demonstrate that the optimisation of the sample-to-answer molecular solution has been successful, paving the way to initiate the 200 subject ovarian cancer clinical verification study of patients who are presenting with a pelvic mass and scheduled for surgery. A positive outcome from the clinical verification study would support ANGLE’s plans to launch a clinical assay for the detection of ovarian cancer in women with an abnormal pelvic mass.
This study is expected to start in early Q3 CY19 and is projected to complete in Q1 CY20. Project timelines assume a similar enrolment rate to the previous 200 patient pelvic mass study conducted by the same clinical centre but patient enrolment is outside of the Company’s control.
ANGLE Founder and Chief Executive, Andrew Newland, commented:
“The performance of ANGLE’s optimised sample-to-answer molecular solution for ovarian cancer in the pre-study is encouraging. We are excited about progressing the full clinical verification study which will help support the launch of a clinical assay at a clinical laboratory and/or via a commercial partnership.”
Approximately 5% to 10% of women will be diagnosed with a pelvic mass during their lifetime, with 13% to 21% of these women being subsequently diagnosed with ovarian cancer. A test to detect circulating tumor cells in the blood and hence ovarian cancer prior to surgery would enable women to be triaged to appropriate surgical procedures improving patient outcomes whilst at the same time reducing overall healthcare costs. ANGLE estimates that the global market size for this clinical application is worth US$1 billion per annum.
Results for ANGLE’s previous 200-subject ovarian cancer study with Rochester were presented at The Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer in New Orleans in March 2018. The assay (combining the Parsortix and HyCEAD Ziplex systems) achieved a high degree of accuracy for the prediction of the presence of ovarian cancer, with a ROC-AUC1 of 95.1%. The novel test achieved higher sensitivity and specificity than any other test available for the same clinical application. In particular, existing tests suffer from low specificity with a high false positive rate.
About Andrew Newland
Andrew Newland is the founder and Chief Executive of ANGLE plc. For over twenty five years, he has specialized in building technology-based businesses based on strong intellectual property and for the last fifteen years he has been Chairman or on the Board of several specialist medical technology companies. Andrew has an MA in Engineering Science from the University of Cambridge, and is a qualified Chartered Accountant.
ANGLE is a world leading liquid biopsy company with sample to answer solutions. ANGLE’s proven patent protected platforms include an epitope-independent circulating tumor cell (CTC) harvesting technology and a downstream analysis system for cost effective, highly multiplexed analysis of nucleic acids and proteins. The Company has launched a product for the research use market and has an In-vitro Diagnostic Devices Directive CE Mark for the indicated clinical use. The FDA clearance process is currently underway for the clinical market in the US.