POSITIVE INTERIM EVALUATION OF OVARIAN CANCER CLINICAL STUDIES

January 26, 2017

ANGLE plc (AIM:AGL OTCQX:ANPCY), the specialist medtech company, is delighted to announce the outcome from the planned interim evaluations of two separate 200 patient ovarian cancer studies, in Europe and the United States. 

The early evaluation of data from both the studies suggest that an assay using the Parsortix system could accurately differentiate between women with a malignant pelvic mass and those with benign tumours, with an additional benefit of providing valuable gene expression information which could help further refine treatment decisions. Such data, if confirmed over the remaining samples, would represent an advantage over currently available clinical risk assessment tools.

The European study is being led by Dr Robert Zeillinger at the Medical University of Vienna and the US study is being led by Dr Richard Moore at the University of Rochester Medical Center, Wilmot Cancer Institute (New York State).  An evaluation of data obtained from the first 50 patients enrolled in each study was undertaken, at the interim stage, in order to optimise the combination of RNA markers to detect malignancy. 

The women in both studies had blood drawn prior to surgery for a diagnosed pelvic mass.  The blood was processed through the Parsortix system to harvest, for evaluation, any circulating tumour cells (CTCs) that may have been present.  The early evaluation of the data indicates that an RNA analysis of those cells harvested by the Parsortix system may enable the accurate and specific diagnosis of ovarian cancer in women with a pelvic mass.   

Patient enrolment into the European study is now over 90% and is expected to be completed in February 2017.  The US study patient enrolment is ahead of schedule with approximately 70% of the required patient sample enrolled and currently on target to be completed by the end of April 2017.  Headline data from the full studies is expected to be available in Q2, 2017.

Ovarian cancer surgery is highly complex and informed decision making has a very strong impact on survival: women with a diagnosis or a strong indication of ovarian cancer are normally referred to a specialist gynaecologic oncology unit for surgery, while others will fall under the care of a local general surgeon or gynaecologist.  Both clinical outcomes and costs are significantly impacted by having the right surgical team in place for the right procedure. It would therefore be of significant clinical benefit to know, in advance of surgery, whether an abnormal pelvic mass is malignant or benign.  ANGLE estimates that the addressable global market for the pre-surgical assessment of ovarian cancer risk, could be in excess of £300 million per annum.

Professor Robert Zeillinger, Head of the Molecular Oncology Group at the Medical University of Vienna, commented:

“The early data evaluation is encouraging.  Using ANGLE’s Parsortix system and a panel of RNA markers, there is the prospect we can meet a key medical need in triaging women before surgery to ensure patients with cancer get the care they need.”

Dr Richard Moore, Director of the Gynecologic Oncology Division, University of Rochester Medical Center Wilmot Cancer Institute, commented:

“The early data points are very promising and indicate that use of a multiplex RNA assay on harvested circulating tumour cells will help to accurately discriminate malignant from benign pelvic masses before surgery and at the same time provide valuable tumour specific genomic information that can help manage patients and their disease in a way that is not currently possible.”

ANGLE Founder and Chief Executive, Andrew Newland, commented:

“The interim data evaluation supports the potential for ANGLE’s first clinical application to out-perform standard of care for the detection of ovarian cancer, particularly in relation to specificity avoiding false positives. Additionally there is an opportunity using Parsortix to obtain molecular information to guide therapy prior to surgery, which is not possible with existing approaches.”

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