By Brian Marckx, CFA
Encouraging Clinical Data
We anticipate release of clinical study data coming from the various trials that are using VolitionRx's (VNRX) NuQ assay technology in the detection of certain cancers. The first of this data, which we would characterize as encouraging, came out last week and was presented by Dr. Stefan Holdenrieder from Bonn University Hospital in Germany at the 8th Circulating Nucleic Acids in Plasma and Serum (CNAPS) congress in Baltimore.
As a reminder, in mid-2012 VNRX entered a collaboration with Bonn University Hospital in Germany (Rheinische Friedrich-Wilhelms-Universitat Bonn) to perform clinical trials in the evaluation of Volition's NuQ assays for cancer diagnosis and in other diseases. Lead investigator of the trials is Dr. Stefan Holdenrieder of the Institute of Clinical Chemistry and Clinical Pharmacology at University Hospital Bonn who is considered a world-renowned expert in the field of circulating nucelosomes and has authored over 70 journal papers. There are currently three studies ongoing at Bonn including an 800-patient retrospective study for various cancer types, a larger (~2,000-patient) prospective study for various cancers as well as non-cancer diseases and a study to validate the tests as a predictor of the performance and therapy monitoring of chemotherapy.
Data was presented from 90 patients (24 colorectal cancer (CRC), 10 benign colorectal diseased (BCD), and 56 healthy controls (HC)) tested with VolitionRx's NuQ-5m assay for colorectal cancer. Results were encouraging and showed the assay was able to detect 75% of patients with colorectal cancer with a 70% specificity. These findings were confirmed on a second set of 113 patients (49 CRC, 26 BCD, 38 HC). The assay detected significantly (at 95% CI) lower levels of NuQ-5mc in CRC and BCD compared to HC although no differences were found between CRC and BCD. Relative to differentiation of CRC from HC, sensitivities improved from 33% at a 95% specificity to 75% at a 70% specificity.
These results compare somewhat similarly to results of a small internal study led VolitionRx's own scientists at its Belgium-based lab which were announced in late 2012. The study included 105 patients including 31 healthy patients and those with cancer of the colon(n=25), breast(n=25), and lung(n=24) were included in the initial results which showed. In the colorectal cancer cohort the NuQ assay had a 76% sensitivity (19 of 25 patients detected), 90% specificity (3 of 31 healthy samples false positive).
Along with the Bonn University-based studies, the NuQ assays are being evaluated in other important colorectal trials, data from which we expect will be forthcoming. This includes an ongoing study at CHU UCL Mont-Godinne, an academic hospital in Yvoir, Belgium as well as the recently announced study at Hvidovre Hospital at the University of Copenhagen in Denmark. The prospective longitudinal study at Mont-Godinne is evaluating patients as they progress through diagnosis and treatment of colorectal cancer. The Denmark-based study will include over 10,000 patient blood samples for analysis with VolitionRx's NuQ tests with the main focus on colorectal cancer.
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