VolitionRx initiates study to assess NuQ blood tests for detection of prostate cancer

VolitionRx Limited (NYSE MKT: VNRX) today announced that it has initiated a study to assess the feasibility of using the Company’s NuQ^® blood tests to detect prostate cancer. The study is in collaboration with the Surrey Cancer Research Institute of the University of Surrey in the UK.

In the retrospective study, 550 blood samples collected from patients attending the hospital will be analyzed using a panel of VolitionRx's NuQ^® biomarker assays. Three groups of patients will be assessed: those with aggressive prostate cancer; those with indolent or slow-growing prostate cancer; and age-matched healthy controls. In addition to determining the NuQ^® blood test's accuracy in detecting prostate cancer, the study will also assess the tests' ability to distinguish among the different prostate conditions and healthy samples.

Approximately 14% of men will be diagnosed with prostate cancer at some point during their lifetime and nearly 3 million men are estimated to be living with prostate cancer in the United States alone. While more than 80% of all prostate cancers are detected at the local stage, and nearly 100% of men diagnosed and treated at this stage will be disease-free after five years, a small percentage of men experience more rapidly growing, aggressive forms of prostate cancer.

VolitionRx Chief Scientific Officer, Dr. Jake Micallef, commented:

I am pleased that we have been able to commence this work in collaboration with Professor Hardev Pandha from the University of Surrey, who is very experienced and well-known in the field of prostate cancer diagnostics. Early detection and the ability to differentiate men with aggressive tumors requiring immediate treatment from men with slow-growing tumors that do not require aggressive treatment are important goals in the field of prostate cancer research. This new study with the University of Surrey will investigate the use of NuQ^® blood tests both for cancer detection and for selection of patients requiring aggressive treatment. This trial of our NuQ^® biomarker assays for more general prostate cancer detection complements the study we have underway in collaboration with MD Anderson, in which we are focusing on anaplastic prostate cancer – one of the most aggressive forms.

Professor Hardev Pandha, Director of the Surrey Cancer Research Institute and Professor of Urological Oncology at the University of Surrey, remarked:

There is an unmet medical need for better diagnostics in prostate cancer. In particular, patient monitoring and selection for treatment currently relies predominantly on the invasive prostate biopsy. Based on the analysis we will conduct in this study and further evaluation in larger studies, it is our hope that VolitionRx's NuQ^® tests will enable non-invasive and cost-effective blood-testing that will result in better diagnosis and treatment, and improved outcomes, for patients with prostate cancer.

Cameron Reynolds, Chief Executive Officer of VolitionRx, added:

We have now developed and manufactured a large suite of NuQ^® biomarker assays which can be run rapidly using our high throughput ELISA robots at low cost. This allows us to investigate an expanding number of disease applications for our NuQ^® tests while continuing to focus on the development and commercialization of regulatory approved products for colorectal cancer at very little extra cost.

In addition to this study, other clinical trials assessing the effectiveness of VolitionRx's biomarker assays in detecting prostate cancer include the following:

• A retrospective study to establish the efficacy of VolitionRx’s NuQ® tests to distinguish anaplastic prostate cancer, a particularly aggressive form of the disease, from typical castration resistant prostate cancer (CRPC), the less aggressive form (MD Anderson Cancer Center, Texas)
• A 120-patient prospective feasibility study (ImmuneHealth, Belgium)

Results from ongoing clinical trials assessing the effectiveness of VolitionRx’s assays, include:

Colorectal cancer and pre-cancerous colorectal polyps

• Interim results from a 4,800 patient retrospective symptomatic population study (Hvidovre Hospital, University of Copenhagen, Denmark), released September 9 2015: Panel of four NuQ® biomarker assays detected 81% of colorectal cancers and 67% of high-risk adenomas at 78% specificity
• Results from a prospective study of 121 patient referred for colonoscopy (CHU Dinant Godinne - UCL Namur, in Belgium), released December 8 2015: Panel of four NuQ® biomarker assays detected 91% of colorectal cancer cases at 90% specificity

Pancreatic cancer

• Results from a 59-patient retrospective study (Lund University, Sweden) published in Clinical Epignetics online journal (http://www.clinicalepigeneticsjournal.com/content/pdf/s13148-015-0139-4.pdf), October 7 2015: Panel of four NuQ^® biomarker assays plus CA 19-9 classical biomarker detected 92% of pancreatic cancers at 100% specificity
• Interim results from a 4,800 patient retrospective symptomatic population study (Hvidovre Hospital, University of Copenhagen, Denmark), released October 22 2015: Panel of two NuQ^® assays and the classical cancer marker CEA (carcino-embryonic antigen) distinguished 95% of pancreatic cancer cases from healthy subjects at 84% specificity

Lung cancer

• Interim results (73 of 240 patients collected and assessed) from a prospective study (Liege University Hospital, Belgium), released November 19 2015: Panel of four NuQ^® biomarker assays detected 93% of lung cancers at 91% specificity