Date: 2014-04-30
Type of information: Initiation of preclinical development
phase: prospective study
Announcement: publication of results in Anticancer Research
Company: VolitionRX (Singapore) - Rheinische Friedrich-Wilhelms-Universität Bonn (Bonn University - Germany)
Product: NuQ® diagnostic platform
Action mechanism:
Disease: breast cancer
colorectal cancer
lung cancer
Therapeutic area: Cancer - Oncology
Country: Germany
Trial details:
Latest
news: * On April 30, 2014, VolitionRx, a life sciences company focused on developing blood-based diagnostic tests for different types of cancer, has announced that preliminary data from University Hospital Bonn, Germany, has been published online in the leading peer-reviewed journal, Anticancer Research. The data, first presented at CNAPS (Circulating Nucleic Acids in Plasma and Serum) congress last year, shows VolitionRx’s single proprietary NuQ®-5mc assay detects 75% of colorectal cancers with 70% specificity. Since then, VolitionRx has achieved even better detection rates by combining its assays. The full article, “Novel Serum Nucleosomics Biomarkers for the Detection of Colorectal Cancer” is available at Anticancer Research’s website at http://ar.iiarjournals.org/content/34/5/2357.abstract?etoc. The independent trial at University Hospital Bonn was coordinated by Dr. Stefan Holdenrieder at the Institute of Clinical Chemistry and Clinical Pharmacology. Using VolitionRx’s NuQ® assay, his team tested 90 patient samples and found significantly lower levels of nucleosomes containing methylated DNA in the blood of patients with colorectal cancer compared to healthy samples, and later validated the results in a second set of 113 people. Last year, VolitionRx proved that it could further improve detection rates by searching for more than one nucleosome biomarker and effectively creating a ‘panel’ test. Using samples from CHU Dinant Godinne/UCL Namur Hospital in Belgium, the team detected 85% of colorectal cancer with 85% specificity when combining two NuQ assays. Other clinical trials assessing the effectiveness of VolitionRx’s assays include: A 4,800 patient retrospective study and an 11,000 patient prospective study into colorectal cancer at Hvidovre Hospital, University of Copenhagen, Denmark A 4,000 patient prospective study that involves patients with the 20 most prevalent cancers at University Hospital in Bonn, Germany A 250 patient study into colorectal cancer at CHU-UCL Mont Godinne Hospital, Belgium. * On November 5, 2012, VolitionRx has announced preliminary findings from its ongoing internal clinical trials of the NuQ® diagnostic platform. VolitionRX has analysed blood samples from 105 patients and was able to detect 76% of the patients with colon cancer, 96% of those with breast cancer, and 100% of patients with lung cancer.
Of the 105 patients tested, 74 had cancer (25 colon cancer, 25 breast cancer and 24 lung cancer), and 31 were healthy (not diagnosed with cancer). Volition tested all the patient samples for elevated nucleosome structures using one of its NuQ kits, with the following results for colon, breast and lung cancer:
• Colon: 76% of cancers detected (19 of 25 patients) and 90% specificity (3 false positives from 31 healthy samples)
• Breast: 96% of cancers detected (24 of 25 patients) and 90% specificity (3 false positives from 31 healthy samples)
• Lung: 100% of cancers detected (24 of 24 patients) and 79% specificity (6 false positives from 28 healthy samples).
Further clinical results will be announced as they become available.
As announced in July, VolitionRx is currently moving through an independent 800-patient (expanded from the initial 400 patients) retrospective study on multiple cancer types, which is being carried out at Rheinische Friedrich-Wilhelms-Universität Bonn and is expected to be completed by the end of this year. Preliminary results from this study based on 62 healthy subjects, 20 patients with benign colon tumors and 35 patients with colorectal cancer are consistent with VolitionRx internal results and indicate that Nucleosomics tests appear to differentiate cancer patients from patients with benign colon tumors as well as healthy patients. Full data from both studies will be published in a peer-reviewed journal when the studies are complete.
