Angle Plc, Guildford, UK, recently shared outcomes from the planned interim evaluation of two separate 200-patient ovarian cancer studies being conducted in the United States and Europe.

Early evaluation of data from both studies suggests that an assay using the company’s Parsortix system can accurately differentiate between women with a malignant pelvic mass and those with benign tumors, with an additional benefit of providing valuable gene expression information that could help further refine treatment decisions.

Photo Moore Richard crop640

Richard G. Moore, MD, University of Rochester Medical Center.

The European study is being led by Robert Zeillinger, PhD, who is head of the molecular oncology group in the department of obstetrics and gynecology at the Medical University of Vienna. The US study is being led by Richard G. Moore, MD, director of the gynecology service line at the Wilmot Cancer Institute of the University of Rochester Medical Center. The investigators undertook an interim evaluation of data obtained from the first 50 patients enrolled in each study, in order to optimize the combination of RNA markers being used 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 tumor cells (CTCs) present in the blood samples. Early evaluation of the data indicates that an RNA analysis of cells harvested by the Parsortix system may enable accurate and specific diagnosis of ovarian cancer in women with a pelvic mass.

“The early data evaluation is encouraging,” says Zeillinger. “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.”

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

Topline data from the full studies are expected to be available in the second quarter of 2017.

Ovarian cancer surgery is highly complex, and informed decisionmaking has a very strong affect on survival. Women with a diagnosis or a strong indication of ovarian cancer are normally referred to a specialist gynecologic oncology unit for surgery, while others will fall under the care of a local general surgeon or gynecologist. Both clinical outcomes and costs are significantly affected by having the right surgical team in place for the right procedure. According to Angle, it would therefore be of significant clinical benefit to know, in advance of surgery, whether an abnormal pelvic mass is malignant or benign.

Andrew Newland, Angle.

Andrew Newland, Angle.

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

For more information, visit Angle.