VolitionRX Signs Collaboration Agreement With Stefan Holdenrieder of Rheinische Friedrich-Wilhelms-Universität Bonn Germany
Company to Host Virtual Road Show Conference Call Tuesday July 17, 2012 at 10:30 am ET
Singapore, July 9, 2012… VolitionRX Limited (OTC:VNRX.OB), a life sciences company focused on developing blood-based diagnostic tests, is pleased to announce that it has entered into a collaboration agreement with Rheinische Friedrich-Wilhelms-Universität Bonn (“Bonn University”), Germany. Under the agreement, Priv.-Doz. Dr. Stefan Holdenrieder of the Institute of Clinical Chemistry and Clinical Pharmacology at University Hospital Bonn will undertake multiple independent clinical trials of VolitionRX’s NuQTM assays. The Company will host a Virtual Road Show conference call on July 17, 2012 at 10:30 am ET. The Virtual Road Show will include a company presentation and overview by management, concluding with Q&A from participants.
Bonn University’s multiple clinical trials will evaluate the performance of VolitionRX’s NuQ tests. The trials will be in three parts:
1. A two month pilot study, using retrospectively-collected patient blood samples;
2. A large multi-year prospective study, during which blood samples will be initially collected from patients at University Hospital Bonn; and
3. A validation of the tests as a predictor of the performance and therapy monitoring of chemotherapy.
The pilot study will be an early clinical evaluation of VolitionRX’s proprietary NuQ and NuQ-X tests on 400 retrospectively-collected patient samples, both from cancer patients and controls (healthy patients). It will provide an early initial evaluation of the diagnostic performance of the tests and correlation of the results with disease characteristics.
During the prospective study, which will commence in July 2012, blood samples will be taken from at least 2000 patients including:
1. Healthy individuals
2. Patients with cancers (age- and gender-matched) including:
3. Patients with other conditions including:
The trial will evaluate the performance of VolitionRX’s tests including all methodical aspects that are relevant for their application in clinical testing and potentially influencing factors in problematic samples. It will also evaluate the influence of preanalytic conditions on the tests, particularly the pre-analysis treatment of the blood samples.
A separate clinical evaluation will be carried out on chemotherapy patients, to evaluate the NuQ tests’ validity for therapy monitoring and response prediction. Samples will be collected from approximately 300 patients with a range of cancers. The samples will be collected before each of the 6 to 8 therapy cycles and will be correlated with the radiological response evaluation. For both clinical scenarios, the NuQ tests will be compared with already established tumor markers to see their specific use in the clinical application.
Priv-Doz. Dr Stefan Holdenrieder, who will coordinate the trials, is based at the Institute of Clinical Chemistry and Clinical Pharmacology at University Hospital Bonn, Rheinische Friedrich-Wilhelms-Universität Bonn. He is an expert in the field of circulating nucleosomes, and is widely published, having authored over 70 journal papers and several patents. Some example relevant publications may be found in the notes below*.
VolitionRX will also engage the German statistical firm, QuoData, which has specific expertise in multiparametric and kinetic analyses, to undertake mathematical and statistical evaluation of the results of the studies.
Cameron Reynolds, CEO of VolitionRX says: “Dr. Holdenrieder is one of the world’s leading researchers in the clinical utility of circulating nucleosomes, and has published many scientific articles on circulating nucleosomes in cancer. We’re excited to be commencing these studies with his laboratory and eagerly await the results. This is the first large prospective study to be carried out on our NuQ tests and we anticipate that on successful outcome, the data from these trials will be used in regulatory applications for CE Mark (European) and FDA (USA) approvals.”
“We will thoroughly evaluate the new assays to see how they can improve current standards of tumor diagnostics and therapy monitoring,” says Priv-Doz Stefan Holdenrieder of University Hospital Bonn. “I have worked in the area of circulating nucleosomes in cancer for many years and I believe they hold great promise in oncology diagnostics and monitoring. I am therefore delighted to be involved in clinical studies on Nucleosomics with VolitionRX.”
Please dial in at least 10 minutes before the call to ensure timely participation. A playback will be available through July 31, 2012. To listen, please call 1-877-870-5176 within the United States, +1-858-384-5517 if calling from other countries. Utilize the pass code 4548131 for the replay. The Virtual Road Show webcast archive will be available on the investor events section of the VolitionRX website at: http://www.volitionrx.com/investor-events.html.
VolitionRX is a life sciences company whose goal is to make its non-invasive blood tests for cancer as common and simple to use as existing diabetic and cholesterol tests on similar formats.
VolitionRX is managed by a well-respected team with extensive experience in diagnostics and commercialization.
VolitionRX’s development activities are currently centered in Belgium and will be augmented by commercialization work in Singapore with a focus on bringing its revolutionary diagnostic products to market first in Europe, then the U.S. and worldwide.
VolitionRX is quoted on the OTC Bulletin Board in the United States of America, under the symbol VNRX.OB.
*Some of Dr Holdenrieder’s notable publications
Singapore (m): +65 92301938
Mark A. McPartland, Senior Vice President
Forward-Looking Statements: 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.