ANGLE has completed the planned interim analysis of two clinical studies, in Europe and the United States, evaluating its Parsortix system in women with ovarian cancer. The data has shown that the system can accurately distinguish malignant masses from benign tumors.
Parsortix is ANGLE’s specialized platform technology that captures tumor cells circulating in blood — even when they are as rare in number as one in 1 billion — and harvests them for analysis.
This early evaluation suggests that an assay using Parsortix technology could accurately distinguish between a malignant pelvic mass and a benign tumor, with the added benefit of providing valuable gene expression information that could help refine treatment decisions.
Surgery for ovarian cancer is highly complex and it would be of significant clinical benefit to know in advance of surgery whether an abnormal pelvic mass is malignant or benign. If confirmed, this technology could transform risk assessment of ovarian cancer.
The European arm of the study (NCT02785731) is being led by Robert Zeillinger, PhD, at the Medical University of Vienna. Patient enrollment in this study is now more than 90% and is expected to be completed in February.
The U.S. arm of the study is being led by Richard Moore, MD, of the University of Rochester Medical Center, Wilmot Cancer Institute. Patient enrollment for this arm is ahead of schedule, with approximately 70% of the required patient sample enrolled and on target to be completed by the end of April.
Headline data from the full studies is expected by mid-2017.
For the interim analysis, 50 patients were evaluated to optimize combination of RNA markers to detect malignancy. In both studies, researchers drew blood before surgery for a diagnosed pelvic mass. Then, this blood was run through the Parsortix system to search for any circulating tumor cells (CTCs), which were then used for evaluation.
“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,” Zeillinger said in a press release.
The early evaluation suggests that an RNA analysis of the cells harvested with Parsortix potentially could enable an accurate diagnosis of ovarian cancer ahead of surgery.
“The early data points are very promising and indicate that use of a multiplex RNA assay on harvested circulating tumor cells 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,” Moore said.