VolitionRx Commences First Large Clinical Trial in Collaboration with Hvidovre Hospital, Denmark

NAMUR, BELGIUM--(Marketwired - Jan 22, 2014) - VolitionRx Limited (OTCQB: VNRX), a life sciences company focused on developing blood-based diagnostic tests for different types of cancer, today announces it has commenced blood sample analysis for its largest clinical study to date, in collaboration with Hvidovre Hospital, Denmark. Samples collected in 2010-2012 from approximately 4,800 patients are being entered into a blind retrospective study to further establish the accuracy of VolitionRx’s proprietary NuQ® assays as an initial screening tool for detecting colorectal cancer.

A previous smaller study in collaboration with CHU Dinant Godinne and UCL Namur Hospital in Belgium used two of VolitionRx’s proprietary NuQ assays to test blood samples. The researchers achieved 85% detection rates for colorectal cancer and more than 50% of precancerous polyps. This latest clinical study will assess these and other assays in hopes of achieving a similar substantial detection rate with a higher patient population number. VolitionRx also completed a small pilot study on samples taken from a cohort of 40 rectal cancer patients at Hvidovre Hospital, achieving similar detection rates to those achieved in the CHU Dinant Godinne study.

Speaking about the new study, Dr. Jake Micallef, Chief Scientific Officer of VolitionRx, commented, “The sheer scale of this 4,800-patient clinical study is far greater than previous studies which have included less than 100 patients. We expect the results will provide us with further proof of NuQ’s ability to accurately detect colorectal cancer.”

All samples assessed in this study are from patients who have undergone a colonoscopy and have confirmed presence or absence of colorectal cancer, other malignancies, polyps or benign bowel diseases. Patient data points such as age, gender and lifestyle choices, as made available from Danish national records, are also included within the analysis to offer greater mapping of possible disease causation.

Professor Hans Jørgen Nielsen, Professor of Surgical Oncology at Hvidovre Hospital in Denmark, remarked, “We greatly anticipate the results from this extensive study particularly as past studies have provided such promising and powerful results. If the findings match our expectations, these data would strongly support the potential of the Nucleosomics science and blood based diagnostics as a powerful aid to increasing the early detection of cancers.”

Cameron Reynolds, CEO of VolitionRx, added, “The results from this study could bring us one step closer to getting our NuQ assay to market. These are exciting times not only for our company, but for the public at large.”

Initial results from this trial are anticipated in the near future.

Collection is expected to begin in April for a second Danish trial, announced in 2013. Hvidovre Hospital is coordinating the collection of samples from approximately 11,000 individuals. Data from these trials will be used to apply for a CE mark for a colorectal cancer test, and will also be submitted to the FDA.

About VolitionRx

VolitionRx is a life sciences company focused on developing blood-based diagnostic tests for different types of cancer. The tests are based on the science of Nucleosomics which is the practice of identifying and measuring nucleosomes in the bloodstream – an indication that cancer is present.

VolitionRx’s goal is to make the tests as common and simple to use, for both patients and doctors, as existing diabetic and cholesterol blood tests. VolitionRx’s research and development activities are currently centered in Belgium as the company focuses on bringing its diagnostic products to market first in Europe, then in the US and ultimately, worldwide.

Safe Harbor Statement

Statements in this press release may be "forward-looking statements". Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates," "optimizing," "potential," "goal," and similar expressions, as they relate to the Company, its business or management, identify forward-looking statements. These statements are based on current expectations, estimates and projections about the Company's business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Actual outcomes and results may, and probably will, differ materially from what is expressed or forecasted in such forward-looking statements due to numerous factors, including those described above and those risks discussed from time to time in the Company's filings with the Securities and Exchange Commission.

Source: VolitionRx

Posted: January 2014

View comments

Hide
(web4)