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Guildford, UK & Rochester, USA – ANGLE plc, the specialist medtech company, is pleased to announce that it has initiated an ovarian cancer study in the United States, in addition to its recently opened European ovarian cancer study. The US study is being led by Dr Richard Moore at the University of Rochester Medical Center Wilmot Cancer Institute (New York State).
Preparation and approvals for the US ovarian cancer study (known as the ANG-003 EMBER study) have been ongoing over recent months. The study has now been formally opened and the first few patients have already been recruited.
The EMBER study is designed to enrol approximately 200 women with a diagnosed pelvic mass who are scheduled to undergo biopsy, laparotomy or laparoscopic surgery at the University of Rochester Medical Center. Enrolment will continue until a total of 50 evaluable women with a histopathologically confirmed malignancy have been identified. Blood from consenting patients will be processed using the ParsortixTM system to harvest any circulating tumour cells (CTCs) that may be present for evaluation. The Parsortix harvests from the women enrolled into the study will be evaluated for the presence of markers associated with malignancy in ovarian cancer cells. These results will then be compared with the histopathological diagnoses post-surgery to assess their association with whether the pelvic mass is benign or malignant.
Additionally, a portion of the Parsortix harvest from each patient will be stored so that it can subsequently be used for verification of the molecular markers identified in ANGLE’s European ovarian cancer study (ANG-001) as being optimal for the detection of ovarian cancer CTCs harvested by the Parsortix system.
Ovarian cancer surgery is highly complex and maximal tumour removal has a very strong impact on survival. Women with the diagnosis or a strong indication of ovarian cancer can be referred for surgery to specialists in gynaecologic oncology. The consequence is a significantly better outcome compared to the situation when surgery is performed by a general gynaecologist and cancer is diagnosed at this point. There would therefore be great clinical benefit if it were known in advance of surgery that an abnormal pelvic mass is malignant. Conversely, women with benign pelvic mass may be treated more easily and cost effectively by a general surgeon in their local hospital. ANGLE estimates that the addressable global market for the pre-surgical assessment of ovarian cancer risk, available for Parsortix sales, could be in excess of £300 million per annum.
The University of Rochester Medical Center is an integrated academic health center with experts and significant research interests in the area of women’s health. Dr Moore, the Director of the Gynecologic Oncology Division, leads Wilmot Cancer Institute’s Gynecology Service Line and serves as Director of the Targeted Therapeutics Laboratory for Gynecologic Cancers.
Dr Moore, an internationally recognised expert on the use of biomarkers to detect ovarian cancer, is ideally qualified to assist ANGLE in its efforts to develop a diagnostic assay for the detection of ovarian cancer. He led the team that developed the Risk of Ovarian Malignancy Algorithm (ROMA), one of two tests currently cleared by the FDA for use as an aid in assessing whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy on surgery. ROMA is based on the HE4 and CA125 biomarkers, which may be over-expressed in the blood of ovarian cancer patients.
Dr Richard Moore, Director of the Gynecologic Oncology Division, University of Rochester Medical Center Wilmot Cancer Institute, commented:
“There remains a large unmet medical need to accurately discriminate benign from malignant pelvic masses before surgery. I am delighted to be working with the Parsortix system. As it works with live cancer cells rather than general markers of disease, it offers the potential for high specificity avoiding the problem of false positives that affects all existing techniques.”
ANGLE Founder and Chief Executive, Andrew Newland, commented:
“The initiation of this US study reflects ANGLE’s determination to secure substantial patient data from multiple locations as soon as possible to demonstrate the effectiveness of the ovarian clinical application and support regulatory approval. We are delighted that Dr Moore and his team at University of Rochester Medical Center are progressing this study so rapidly.”