Topline Data from 1,000-Subject Independent Blinded Trial to be Presented 9am PT Today during Aegis Capital 2014 Healthcare & Technology Conference; webcast at volitionrx.com
NAMUR, Belgium, September 11, 2014 /PRNewswire/ — VolitionRx Limited (OTCQB: VNRX), a life sciences company focused on developing blood-based diagnostic tests for a broad range of cancer types, today announced that CEO Cameron Reynolds will this morning present topline data from its 4,800-subject colorectal cancer trial at Hvidovre Hospital, Copenhagen, Denmark. Mr. Reynolds will present data from an initial representative 938-subject sample, demonstrating that the Company is able to correctly diagnose 84% of colorectal cancers, including early-stage cancers, using its NuQ® blood-based diagnostic platform.
Mr. Reynolds will discuss the data during a presentation at the 2014 Aegis Capital Healthcare & Technology Conference today at 9:00 a.m. U.S. Pacific Time. Mr. Reynolds’ presentation will be available from today on the Company’s website at www.volitionrx.com.
Despite the existence of screening programs for the disease, colorectal cancer remains the second leading cause of cancer-related death in the U.S.[i], partly due to the cost, and to low compliance with colonoscopies and other screening methods like fecal tests. Furthermore, colorectal cancer is often found after symptoms appear, which typically only happens with more advanced disease[i]. However, colorectal cancer is one of the more survivable diseases if caught early: it has an observed five-year survival rate of 74% in stage I, but only 6% in stage IV[i]. Put simply, many lives could be saved if colorectal cancer were caught earlier. VolitionRx’s NuQ® test aims to meet this need by detecting colorectal cancer through a simple, accurate, cost-effective, blood test.
Analysis of the 938-subject sample of the study demonstrated that the NuQ® diagnostic test detected 84 percent of colorectal cancers at 78% specificity, and 60 percent of polyps, in a population aged over 50 years with symptoms indicative of colorectal cancer. The NuQ® test used to achieve these results was a panel of three individual NuQ® assays, each of which identifies and measures a separate nucleosome structure in the blood. Each NuQ® panel used a small amount of blood – only 60L or about a drop per subject. Data showed that the NuQ® test is able to detect early stage (I or II) disease and late-stage (III or IV) disease with similar accuracy, allowing for earlier detection and treatment of colorectal cancer and enabling the potential for improved patient outcomes.
Dr. Jake Micallef, Chief Scientific Officer of VolitionRx, commented, “VolitionRx has shown similar results previously in smaller colorectal cancer studies but confirmation that NuQ® tests are effective in a large, blind study is a landmark result for us. Moreover, the Nucleosomics® technology is not limited to the three assays used in this study, but incorporates hundreds of potential epigenetic NuQ® tests that may have applicability in colorectal and other cancers. We will share further analysis of the results from these 938 subjects at the 9th International Conference of Anticancer Research in October this year.”
Professor Hans Jorgen Nielsen, Professor of Surgical Oncology at Hvidovre Hospital in Denmark, remarked, “This is an extremely promising result in a symptomatic population. Collection has now begun for a much larger 14,000-subject screening study in Denmark, and we expect to begin delivering the first several thousand samples to VolitionRx for analysis in the early part of 2015.”
Cameron Reynolds, Chief Executive Officer of VolitionRx Limited, commented, “An accurate, early, and cost effective blood test to screen for colorectal cancer would mark a revolutionary advancement in the way we test for and diagnose this terrible disease. These exciting results from our latest analysis, which demonstrated 84% accuracy in colorectal cancer detection, confirm that the NuQ® test enables accurate early identification of colorectal cancer through a simple blood test.”
VolitionRx has today closed a fund raise of $1.127 million. The raise consists of 512,614 shares at $2.20 (including insider conversions of $46,748). Monies raised will go towards VolitionRx’s ongoing operations and clinical trials.
VolitionRx will host a conference call to discuss this data, raise and the Company’s ongoing strategy on Tuesday, September 16 at 10 a.m. US Eastern Time. To attend the call, please use the information below for dial-in access. When prompted on dial-in, please utilize the conference ID or ask for the “VolitionRx Limited Investor Conference Call.”
Tuesday, September 16, 2014
10:00 a.m. Eastern Time, U.S.
Conference Line Dial-In (U.S.):
International/Toll Dial In:
Please dial in at least 10 minutes before the call to ensure timely participation. A playback will be available through September 30, 2014. To listen, please call +1-877-870-5176 within the United States or +1-858-384-5517 if calling internationally. Utilize the pass code 64623766 for the replay.
[i] American Cancer Society. “Colorectal Cancer,” 2014. Available at: http://www.cancer.org/acs/groups/cid/documents/webcontent/003096-pdf.pdf
VolitionRx is a life sciences company focused on developing blood-based diagnostic tests for different types of cancer. The tests are based on the science of Nucleosomics which is the practice of identifying and measuring nucleosomes in the bloodstream – an indication that cancer is present.
VolitionRx’s goal is to make the tests as common and simple to use, for both patients and doctors, as existing diabetic and cholesterol blood tests. VolitionRx’s research and development activities are currently centred in Belgium as the company focuses on bringing its diagnostic products to market first in Europe, then in the U.S. and ultimately, worldwide.
About the Trial
This representative blinded 938-subject sample (these results were CRC versus no findings on colonoscopy and no comorbidities) was drawn from a 4,800 symptomatic-subject study conducted at Hvidovre Hospital, Copenhagen, Denmark. Samples were collected from 2010 to 2012 from subjects with colorectal cancer, polyps or adenomas, benign bowel diseases or other malignancies, all of whom have undergone a colonoscopy. Under the trial design, VolitionRx has full anonymized access to all Danish national registries and databases. The study group were all aged over 50; results were age- and gender-adjusted.
Safe Harbor Statement
Statements in this press release may be “forward-looking statements”. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “optimizing,” “potential,” “goal,” and similar expressions, as they relate to the Company, its business or management, identify forward-looking statements. These statements are based on current expectations, estimates and projections about the Company’s business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Actual outcomes and results may, and probably will, differ materially from what is expressed or forecasted in such forward-looking statements due to numerous factors, including those described above and those risks discussed from time to time in the Company’s filings with the Securities and Exchange Commission.
Charlotte Reynolds, VolitionRx
Telephone: +44 (0) 795 217 7498
Kirsten Thomas, The Ruth Group
Telephone: +1 (646) 536-7014
Scott Powell, VolitionRx
Telephone: +1 (917) 721-9480
Lee Roth, The Ruth Group
Telephone: +1 (646) 536-7012