AUSTIN, Texas, May 7, 2019 /PRNewswire/ — VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") today announced that it has added to its extensive clinical trial program with the execution of a contract under the previously announced Memorandum of Understanding, to conduct its first large-scale lung cancer study in conjunction with the prestigious National Taiwan University ("NTU"). The study will be conducted under the supervision of Professor Chen Jin-Shing in the Department of Surgery of NTU and will include 1,200 subjects receiving Low-Dose Computed Tomography scans, including 1,000 with lung cancer.
Professor Chen Jin-Shing commented: "Lung cancer remains the deadliest of all the cancers and there is a high unmet clinical need for either a non-invasive early stage lung cancer detection test or for a triage test which can improve the specificity of the Low-Dose CT scan currently used. The early data from the Nu.Q™ technology platform is promising, and clearly larger scale studies are required. We are delighted to execute this agreement and very much look forward to evaluating the Nu.Q™ technology platform".
"We are delighted with the progress we have achieved with the network of key influencers and collaborators in Asia and in particular our expanded relationship with the National Taiwan University," commented Dr. Jasmine Kway, Chief Executive Officer of Singapore Volition. "At a total cost of approximately $320,000 payable over two years, this study demonstrates once more Volition’s commitment to conducting large yet cost effective trials worldwide. We are hopeful that our recent proof of concept results in lung cancer will be repeated in this much larger cohort. We expect to release preliminary data relating to the first 600 patient samples in the first quarter of 2020."
Volition recently announced preliminary results from two proof of concept studies utilising its first optimized product-grade assay:
In a lung cancer cohort (76 subjects), a single Nu.Q™ assay detected lung cancer, including stage I lung cancer. The Area Under the Curve ("AUC") for this single assay was 85%, cancer versus healthy.
In a second confirmatory lung cancer cohort (152 subjects), the same single Nu.Q™ assay also detected lung cancer with an AUC of 79%, cancer versus healthy.
Volition has also recently executed a nonbinding Memorandum of Understanding with Shanghai Fosun Long March Medical Science Co., Ltd. with the shared intention to enter into a binding agreement and to conduct three small-scale clinical trials in China. One of the trials is in lung cancer, and the others are in colorectal cancer and ovarian cancer, with preliminary data expected in 2019.
About the National Taiwan University
NTU is one of the most prestigious universities in the world and is the top university in Taiwan. The University has a wide network of partners and collaborators and plays a leading role in education and research. The University has four university level research centers, with an overall student population of approximately 33,000.
Volition is a multi-national life sciences company developing simple, easy to use, cost effective blood tests to help diagnose a range of cancers and other diseases. Early diagnosis has the potential to not only prolong the life of patients, but also to improve their quality of life. The tests are based on the science of Nucleosomics™, which is the practice of identifying and measuring nucleosomes in the bloodstream or other bodily fluid – an indication that disease is present.
Volition’s research and development activities are currently centered in Belgium, with additional offices in Texas, London and Singapore, as the company focuses on bringing its diagnostic products to market.
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Statements in this press release may be "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. Words such as "expects," "anticipates," "intends," "plans," "aims," "targets," "believes," "seeks," "estimates," "optimizing," "potential," "goal," "suggests," "could," "would," "should," "may," "will" and similar expressions identify forward-looking statements. These forward-looking statements relate to the negotiation and execution of a binding agreement with Fosun Long March Medical Science Co., Ltd. and the timing of availability of preliminary data under such agreement, the effectiveness of Volition’s blood-based diagnostic tests as well as Volition’s ability to develop and successfully commercialize such test platforms for early detection of cancer and other diseases. Volition’s actual results may differ materially from those indicated in these forward-looking statements due to numerous risks and uncertainties. For instance, if Volition fails to develop and commercialize diagnostic products, it may be unable to execute its plan of operations. Other risks and uncertainties include Volition’s failure to obtain necessary regulatory clearances or approvals to distribute and market future products in the clinical IVD market; a failure by the marketplace to accept the products in Volition’s development pipeline or any other diagnostic products Volition might develop; Volition will face fierce competition and Volition’s intended products may become obsolete due to the highly competitive nature of the diagnostics market and its rapid technological change; and other risks identified in Volition’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as other documents that Volition files with the Securities and Exchange Commission. These statements are based on current expectations, estimates and projections about Volition’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. Forward-looking statements are made as of the date of this release, and, except as required by law, Volition does not undertake an obligation to update its forward-looking statements to reflect future events or circumstances.
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