SINGAPORE, July 9, 2012 /PRNewswire/ -- 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-Universitat 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 NuQ 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:
a. Twenty of the most prevalent major organ and hematological cancers
b. Diverse stages
c. Diverse histologies
d. Clinical characteristics
3. Patients with other conditions including:
a. Organ-related benign diseases
b. Metabolic diseases such as renal failure and autoimmune disease
c. Acute diseases such as sepsis, inflammation, trauma and stroke
d. Chronic degenerative diseases
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-Universitat 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."
Virtual Road Show (VRS) Conference Call and Webcast Details:
To register for the event, please contact Mark McPartland from MZ Group via email at firstname.lastname@example.org or call +1-212-301-7130. Once registered, please use the dial-in access and webcast access information below. When prompted on dial-in, ask for "VolitionRX Virtual Road Show Conference Call."
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
- Holdenrieder et.al., "Nucleosomes in serum of patients with benign and malignant diseases" International Journal of Cancer. Volume 95, Issue 2, pages 114120, 20 March 2001.
- Holdenrieder et.al., "Circulating Nucleosomes Predict the Response to Chemotherapy in Patients with Advanced NonSmall Cell Lung Cancer"Clin Cancer ResSeptember 15, 2004 10; 5981.
- Holdenrieder et al., "Nucleosomes, ProGRP, NSE, CYFRA 21-1 and CEA in the therapy monitoring of small-cell lung cancer during first-line chemotherapy" Clin Cancer Res 2008; 14: 7813-7821.
- Holdenrieder S, Stieber P., "Clinical use of circulating nucleosomes" Crit Rev Lab Med Sci 2009; 46: 1-24.
- Fahmuller, ..., Holdenrieder., "Predictive and prognostic value of circulating nucleosomes and serum biomarkers in patients with metastasized colorectal cancer undergoing Selective Internal Radiation Therapy." BMC Cancer 2012 Jan 4;12:5. doi: 10.1186/1471-2407-12-5.
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SOURCE VolitionRX Limited