Date: 2014-04-24
Type of information: Clinical research agreement
Compound: NuQ™ assays
Company: VolitionRX (Singapore) Rheinische Friedrich-Wilhelms-Universität Bonn (Bonn University) (Germany)
Therapeutic area: Diagnostic - Cancer - Oncology
Type agreement: collaboration
clinical research
Action mechanism: NuQ™ and NuQ-X™ tests belong to a range of blood-based epigenetic cancer early detection tests. These tests are used for the detection of the level of nucleosomes in a patient’s blood. The above tests are being developed to work together: The basic NuQ test will be used as a frontline test for the level of nucleosomes in the blood. If the results of this test are negative, there is likely no cancer and further testing is not immediately required. If the results of the NuQ test are positive, the patient may have cancer or another condition so further testing will be required to a) confirm whether the patient has cancer or another condition; and b) if there is cancer, to determine the specific subtype of cancer This will be done using the NuQ-V tests and the NuQ-M test in conjunction (collectively called the “NuQ panel”). NuQ-X™ is a family of blood tests for the detection of nucleosomes containing specific nucleotides.
Disease: major organ and hematological cancers
Details: * On July 9, 2012, VolitionRX, a life sciences company focused on developing blood-based diagnostic tests, has entered into a collaboration agreement with Rheinische Friedrich-Wilhelms-Universität Bonn (Bonn University). Under the agreement, 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.
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. 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:
• Twenty of the most prevalent major organ and hematological cancers
• Diverse stages
• Diverse histologies
• Clinical characteristics
3. Patients with other conditions including:
• Organ-related benign diseases
• Metabolic diseases such as renal failure and autoimmune disease
• Acute diseases such as sepsis, inflammation, trauma and stroke
• 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.
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.
Financial terms:
Latest news: * On April 24, 2014, VolitionRx has announced that it has extended its agreement with University Hospital Bonn, Germany, pursuant to which University Hospital Bonn will externally conduct the performance evaluation for CE marking of VolitionRx’s proprietary NuQ®; assays as a tool for detecting colorectal cancer. Additionally, as part of the agreement, the Hospital has doubled the size of its prospective study from 2,000 to 4,000 patients and agreed to a range of other work including launching a 100-patient lung cancer-specific prognostic monitoring trial. The CE mark performance evaluation will be led by Priv-Doz. Dr. Stefan Holdenrieder at the Institute of Clinical Chemistry and Clinical Pharmacology, University Hospital Bonn. His team will use VolitionRx’s NuQ® kits as a confirmatory trial on patient samples from VolitionRx’s ongoing collaboration with Hvidovre Hospital, Denmark, for CE regulatory purposes. Dr. Holdenrieder is also leading the expanded German prospective study, which is designed to evaluate the performance of VolitionRx’s assays across patients with the 20 most prevalent cancer types and matched healthy individuals and those with competing conditions. VolitionRx aims to complete the CE mark application process in 2014. As part of the expanded collaboration, University Hospital Bonn will also perform a wide range of beta testing and pre analytics that are key to further refining the Nucleosomics technology.
