Date: 2014-10-09
Type of information: Presentation of results at a congress
phase:
Announcement: presentation of results at the 9th International Conference of Anticancer Research, being held October 6-10, 2014 in Sithonia, Greece
Company: VolitionRx (Singapore) Hvidovre Hospital (Denmark)
Product: NuQ® assays
Action
mechanism: VolitionRx's NuQ® tests utilize the Company's proprietary Nucleosomics® platform, which identifies and measures circulating nucleosome structures for the presence of epigenetic cancer signals within the blood. As part of the trial, VolitionRx is analyzing samples from approximately 4,800 subjects with colorectal cancer, polyps or adenomas, benign bowel diseases or other malignancies, all of whom have undergone a colonoscopy.
Disease: colorectal cancer
Therapeutic area: Cancer - Oncology
Country: Denmark
Trial
details: All samples assessed in this study are from patients who have undergone a colonoscopy and have confirmed presence or absence of colorectal cancer, other malignancies, polyps or benign bowel diseases. Patient data points such as age, gender and lifestyle choices, as made available from Danish national records, are also included within the analysis to offer greater mapping of possible disease causation.
Latest
news: In addition, the NuQ® test was shown to identify the majority of colorectal cancers as being either colon or rectal cancers. This is in addition to, and consistent with, VolitionRx's previous findings that the NuQ® test can distinguish between colorectal cancer and prostate cancer cases. The NuQ® test used to achieve these results was a panel of NuQ® assays run on the sample set, each of which identifies and measures a separate nucleosome structure in the blood. Each NuQ® panel used a small amount of blood - only 60µL, or approximately one drop, per subject. VolitionRx is continuing to look at different combinations of these assays to analyze the nucleosome structural patterns of pre-cancers and other conditions of the patients from this trial and will release those results when the analysis is completed. In addition to this study, other clinical trials assessing the effectiveness of VolitionRx's assays include: A 14,000 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 A study with MD Anderson, Texas, to establish the efficacy of VolitionRx's NuQ® tests to distinguish anaplastic prostate cancer, a particularly aggressive form of the disease, from typical castration resistant prostate cancer (CRPC), the less aggressive form.* On October 9, 2014, VolitionRx, a life sciences company focused on developing blood-based diagnostic tests, announced that further data analysis from its colorectal cancer study was presented at the 9th International Conference of Anticancer Research, being held October 6-10, 2014 in Sithonia, Greece. The data released comes from an initial representative 938-subject sample of VolitionRx's 4,800-subject colorectal cancer trial, and was presented at the session "Diagnosis and Prognosis of Cancer". The latest findings include data analysis performed for 830 of the first 938 subjects tested, as analysis was restricted to subjects greater than 50 years of age on whom all the tests were completed. Among the 830 subjects, a total of 59 colorectal cancer cases were identified by colonoscopy, including 35 colon cancer and 24 rectal cancer cases. Of the 59 colorectal cancer cases, the NuQ® blood test was able to detect both early (I or II) and late (III or IV) stage cases with high accuracy. The data, as detected by the NuQ® test, is summarized in the following table:
Stage of
Colorectal
Cancer
Number of
Cancer Cases
Identified Accurately
by NuQ® Test
Corresponding Percentage
of Cancer Cases
Identified Accurately
by NuQ® Test
Early
Stage I
6 of 8
75%
Early
Stage II
19 of 20
95%
Late
Stage III
16 of 20
80%
Late
Stage IV
9 of 11
82%
A previous smaller study in collaboration with CHU Dinant Godinne and UCL Namur Hospital in Belgium used two of VolitionRx’s proprietary NuQ assays to test blood samples. The researchers achieved 85% detection rates for colorectal cancer and more than 50% of precancerous polyps. This latest clinical study will assess these and other assays in hopes of achieving a similar substantial detection rate with a higher patient population number. VolitionRx also completed a small pilot study on samples taken from a cohort of 40 rectal cancer patients at Hvidovre Hospital, achieving similar detection rates to those achieved in the CHU Dinant Godinne study.
This trial is part of the agreement announced in May 2013 by VolitionRx and Hvidovre Hospital for two colorectal cancer clinical trials. Collection is expected to begin in April for the second Danish trial, Hvidovre Hospital is coordinating the collection of samples from approximately 11,000 individuals. Data from these trials will be used to apply for a CE mark for a colorectal cancer test, and will also be submitted to the FDA.
