"VolitionRx Enters Agreement with University of Oxford to Initiate Endometriosis Study
Study will assess VolitionRx's proprietary Nucleosomics® platform for non-invasive diagnosis of endometriosis
November 11, 2014: 08:00 AM ET
NAMUR, Belgium, Nov. 11, 2014/PRNewswire/ -- VolitionRx Limited(OTCQB: VNRX), a life sciences company focused on developing blood-based diagnostic tests, today announced that it has entered an agreement with the University of Oxford, United Kingdom, to initiate a clinical study that will assess VolitionRx's proprietary Nucleosomics® platform technology for the diagnosis of endometriosis through a simple blood test. Under the agreement, The University of Oxford will provide VolitionRx with serum and plasma samples from approximately 350 patients with endometriosis and 150 control patients over a period of two years. The samples are donated by participating women through the biospecimen repository of the Oxford Endometriosis CaRe Centre.
Endometriosis is a common and painful condition in which endometrial tissue, which normally lines the cavity of the uterus, grows in other parts of the body[1]. It is a benign condition with a strong inflammatory component, which makes the disease a good candidate for Volition's NuQ® assays. The condition mostly affects women during their reproductive life span, and is a leading cause of difficulty conceiving. Unfortunately, there are currently no clinically useful biomarkers available for this condition, meaning diagnosis is only possible by performing minimally invasive surgery (laparoscopy). Across the world, this typically results in a delay in diagnosis of nearly 7 years[2].
The prospective study will focus on the development of a simple blood test to help clinicians diagnose endometriosis at an earlier stage. The 350-patient sample collection, supplemented with approximately 150 retrospectively-collected samples, will comprise healthy and endometriosis-positive individuals confirmed by laparoscopy. Differences in circulating nucleosomes will be evaluated across the menstrual cycle using VolitionRx's Nucleosomics® technology platform.
Collection of the samples will be led by Prof Christian Becker and Prof Krina Zondervan, of the Nuffield Department of Obstetrics & Gynaecology, University of Oxford, who are co-Directors of the Endometriosis CaRe Centre, Oxford. The Centre is a world leader in endometriosis research and clinical care and is dedicated to improve the life of women affected by the disease. The study will assess the samples collected from patients undergoing laparoscopic surgery for endometriosis-related symptoms or patients undergoing laparoscopic tubal sterilisation. Sample collection is anticipated to end in 2016 as part of an ongoing biospecimen collection and biobanking program.
"We are excited to sign this agreement with the University of Oxford," commented Dr. Mark Eccleston, VolitionRx's Collaborations Manager. "We look forward to assessing the potential of our test in the diagnosis of endometriosis and to build on our ongoing work in cancer screening by exploring applications of our NuQ® assays in diseases beyond cancer."
Prof Becker said: "We are looking forward to the results of this study. It compliments our ongoing efforts in the Endometriosis CaRe Centre of identifying non-invasive biomarkers for endometriosis which will be an essential step towards improved patient care."
In addition to this study, other clinical trials assessing the effectiveness of VolitionRx's assays include:
A 4,800 patient retrospective study and an 14,000 patient prospective study in colorectal cancer at Hvidovre Hospital,University of Copenhagen, DenmarkA 4,000 patient prospective study that involves patients with the 20 most prevalent cancers at University Hospital in Bonn,GermanyA 250 patient study in colorectal cancer at CHU-UCL Mont Godinne Hospital, BelgiumA 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.
[1]
Office of Women's Health. Endometriosis Fact Sheet. Available at: http://www.womenshealth.gov/publications/our-publications/fact-sheet/endometriosis.html
[2]
Nnoaham, K.E. et al. Impact of endometriosis on quality of life and work productivity: a multicenter study across ten countries. Fertil Steril. 2011;96(2):366-373.
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About VolitionRx
VolitionRx is a life sciences company focused on developing blood-based diagnostic tests. 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 inEurope, then in the US and ultimately, worldwide.
Visit VolitionRx's website (www.volitionrx.com) or connect with us via Twitter, LinkedIn or Facebook.
Media Contacts
Charlotte Reynolds, VolitionRx
Charlotte.Reynolds@volitionrx.com
Telephone: +44 (0) 795 217 7498
Kirsten Thomas, The Ruth Group
kthomas@theruthgroup.com
Telephone: +1 (646) 536-7014
Investor Contacts
Scott Powell, Investor Relations
S.Powell@volitionrx.com
Telephone: +1 (646) 650-1351
Lee Roth, The Ruth Group
lroth@theruthgroup.com
Telephone: +1 (646) 536-7012" http://money.cnn.com/news/newsfeeds/articles/prnewswire/CN62698.htm
Saturday, November 15, 2014
Saturday, November 1, 2014
Chronic Inflammation causes unwell feeling and depression
We have seen in several previous posts the numerous inflammatory markers seen in endometriosis.
This inflammation often gives rise to a general unwell feeling:
"Cytokines mediate and control immune and inflammatory responses. Complex interactions exist between cytokines, inflammation and the adaptive responses in maintaining homeostasis , health, and well-being. Like the stress response, the inflammatory reaction is crucial for survival and is meant to be tailored to the stimulus and time. A full-fledged systemic inflammatory reaction results in stimulation of four major programs: the acute phase reaction, the sickness syndrome, the pain program, and the stress response, mediated by the hypothalamic-pituitary-adrenal axis and the sympathetic nervous system. Common human diseases such as atopy/allergy, autoimmunity, chronic infections and sepsis are characterized by a dysregulation of the pro- versus anti-inflammatory and T helper (Th)1versus Th2 cytokine balance. Recent evidence also indicates the involvement of pro-inflammatory cytokines in the pathogenesis of atherosclerosis and major depression, and conditions such as visceral-type obesity, metabolic syndrome and sleep disturbances. During inflammation, the activation of the stress system, through induction of a Th2 shift, protects the organism from systemic ‘overshooting’ with Th1/pro-inflammatory cytokines. Under certain conditions, however, stress hormones may actually facilitate inflammation through induction of interleukin (IL)-1, IL-6, IL-8, IL-18, tumor necrosis factor- and C-reactive protein production and through activation of the corticotropin releasing hormone/substance P-histamine axis. Thus, a dysfunctional neuroendocrine-immune interface associate with abnormalities of the systemic anti-inflammatory feedback’ and/or ‘hyperactivity’ of the local pro-inflammatory factors may play a role in the pathogenesis of atopic/allergic and autoimmune diseases, obesity, depression, and atherosclerosis. These abnormalities and the failure of the adaptive systems to resolve inflammation affect the well-being of the individual, including behavioral parameters, quality of life and sleep, as well as indices of metabolic and cardiovascular health. These hypotheses require further investigation, but the answers should provide critical insights into mechanisms underlying a variety of common human immune-related diseases." http://www.depts.ttu.edu/animalwelfare/classes/ANSC%205318/Topics%20Stress%20&%20Immunity/Elenkovcytokineswellbeing2005.pdf
"Cytokine dysregulation, inflammation and well-being.
Abstract
"Anyone who has experienced a viral or bacterial infection knows what it means to feel sick. The behaviour of sick people changes dramatically; they often feel feverish and nauseated, ignore food and beverages, and lose interest in their physical and social environments. They tire easily and their sleep is often fragmented. In addition, they feel depressed and irritable, and can experience mild cognitive disorders ranging from impaired attention to difficulties in remembering recent events. Despite their negative impact on well-being, these symptoms of sickness are usually ignored. They are viewed as uncomfortable but banal components of infections1.
Sickness is a normal response to infection, just as fear is normal in the face of a predator. It is characterized by endocrine, autonomic and behavioural changes and is triggered by soluble mediators that are produced at the site of infection by activated accessory immune cells. These mediators are known as pro-inflammatory cytokines, and include interleukin-1α and β (IL-1α and IL-1β), tumour necrosis factor-α (TNF-α) and interleukin-6 (IL-6). They coordinate the local and systemic inflammatory response to microbial pathogens. However, these peripherally produced cytokines also act on the brain to cause the aforementioned behavioural symptoms of sickness. Recently, it has been suggested that ‘sickness behaviour’2,3, a term used to describe the drastic changes in subjective experience and behaviour that occur in physically ill patients and animals, is an expression of a previously unrecognized motivational state. It is responsible for re-organizing perceptions and actions to enable ill individuals to cope better with an infection4. During the last five years, it has been established that pro-inflammatory cytokines induce not only symptoms of sickness, but also true major depressive disorders in physically ill patients with no previous history of mental disorders. Some of the mechanisms that might be responsible for inflammation-mediated sickness and depression have now been elucidated. These findings suggest that the brain–cytokine system, which is in essence a diffuse system, is the unsuspected conductor of the ensemble of neuronal circuits and neurotransmitters that organize physiological and pathological behavior...." Please read the full article at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2919277/ From inflammation to sickness and depression: when the immune system subjugates the brain: Robert Dantzer, Jason C. O’Connor, [...], and Keith W. Kelley
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