ANGLE plc has announced that the Medical University of Vienna, one of its key opinion leaders, has published highly encouraging results in support of the use of ANGLE’s Parsortix system in the detection of ovarian cancer.
Further to the announcement on 27 January 2015, the Medical University of Vienna has extended the work undertaken and published results from its work with the Parsortix system at the American Association for Cancer Research Annual Meeting 2015 being held in Philadelphia (“AACR”). AACR is one of the world’s largest and most influential cancer conferences. Following the results announced in January, the Medical University of Vienna submitted an abstract and we are extremely pleased that this was accepted for publication as a poster at the conference, which is released. Professor Robert Zeillinger and Dr Eva Obermayr are attending the conference to support the poster.
The poster can be downloaded from the ANGLE website here http://www.angleplc.com/the-parsortix-system/download-files/. The poster significantly extends the work announced in January in terms of the number of patients analyzed, the types of cancers considered and the performance achieved.
The study evaluated a total of 65 patients, comprising 42 cancer patients and 23 healthy normal volunteers. The cancer patients consisted of 24 ovarian cancer, 6 cervical cancer, 5 endometrial cancer and 7 breast cancer cases. The analysis of 7 RNA markers yielded 100% specificity, which indicates no false positives, a major problem with existing techniques. The sensitivity of ovarian cancer was 80% at the point of diagnosis and 78% at relapse, which compares favourably to the 24.5% sensitivity, which is the best that has been achieved with other circulating tumour cell (“CTC”) systems.
The important new data shows that a sensitivity of 71% was achieved with the metastatic breast cancer patients, which is more than twice as high as achieved in studies using other CTC systems.
To improve the sensitivity further, the Medical University of Vienna reanalyzed the RNA information using 30 RNA markers with the thresholds set for 100% specificity. So far this work has been completed for 13 of the cancer patients. The addition of 23 further RNA markers yielded an increased sensitivity level averaging 92% across all the cancer types. Notably the sensitivity and specificity for the 7 ovarian cancer patients that were re-analyzed were both 100% at diagnosis and at relapse. This meant that all the ovarian cancer patients were correctly identified using the Parsortix blood test and there were no false positives or false negatives. Larger sample sizes will be needed to complete optimization and confirm these improved results.
With this new highly sensitive approach, the Medical University of Vienna undertook analysis of a woman at high risk of developing ovarian and breast cancer as a result of BRCA1/2 mutation. The woman appeared healthy, had no symptoms and conventional diagnosis including ultrasound and the CA-125 serum tumour marker indicated that she was disease-free. However, like Angelina Jolie, the woman elected to undergo risk-reducing surgery to remove her ovaries. The Parsortix blood sample taken prior to surgery indicated that the woman was positive for ovarian cancer. This was initially thought to be a false positive. However, contrary to all the medical expectations and results from conventional diagnosis, when the surgery was undertaken the woman was in fact found to have ovarian cancer.
This is only one case but it demonstrates the exceptional sensitivity of the Parsortix system and may provide a monitoring option for the approximately 1 in 380 women worldwide who are BRCA1/2 positive and at high risk of developing cancer.
The Medical University of Vienna is now progressing a multi-centre prospective clinical study in ovarian cancer, which is expected to take around 18 months to complete. ANGLE is supporting this effort as a top priority.
ANGLE’s Parsortix system together with the RNA marker panel has the potential to help inform clinical decision-making for ovarian cancer patients in:
• Detection of cancer in high risk or genetically pre-disposed patients (detection)
• Monitoring therapy and selection of therapies in treatment of ovarian cancer patients (therapy monitoring)
• Monitoring of ovarian cancer patients in remission for early detection of relapse (remission monitoring)
ANGLE estimates that the ovarian cancer sales potential for the Parsortix system in Europe and the United States would be in excess of £300 million per annum.
Dr Eva Obermayr, Principal Investigator at the Medical University of Vienna, commented: “The Parsortix technology contributes to the unprecedented specificity and sensitivity of the overall approach, by providing a high purity CTC sample. Parsortix is a label-free technology, and as such may become the gold standard for ovarian cancer diagnosis. By combining the Parsortix technology with qPCR analysis, we achieved an unprecedented high detection rate of cancer, even in early stage patients, where conventional diagnostic methods failed.”
Professor Robert Zeillinger, Head of the Molecular Oncology Group at the Medical University of Vienna, commented: “It is now evident that the Parsortix system has wide application not just in ovarian cancer but in breast cancer and other gynaecological cancers as well. We are delighted to be working with ANGLE to bring this new capability to our patients as soon as possible.”
ANGLE Founder and Chief Executive, Andrew Newland, commented: “The prospect of a simple blood test for cancer detection with such high sensitivity and specificity is extremely exciting. The results published today by Medical University of Vienna substantiate the early findings in ovarian cancer and extend the opportunity into breast cancer and other gynaecological cancers.”