News Article | May 19, 2017
Inmedix, the leader in heart rate variability (HRV) application as an informative diagnostic tool in autoimmune disease, today announced the establishment of a subsidiary, Inmedix UK, Ltd. In coordination with the National Institute for Health Research (NIHR) Office for Clinical Research Infrastructure (NOCRI) and with input from the National Institute for Health Care Excellence (NICE), Inmedix seeks to evaluate its ANS Neuroscan within a single payer system to more fully evaluate its health economic impact. Daniel Austen will direct Inmedix UK Ltd. logistics in cooperation with rheumatology Professors Ernest Choy, and Peter Taylor. Choy serves as Head of Rheumatology and Translational Research at the Institute of Infection and Immunity and Director of the Cardiff Regional Experimental Arthritis Treatment and Evaluation (CREATE) Centre at Cardiff University School of Medicine. Taylor is Professor of Musculoskeletal Sciences at the University of Oxford and Director of Clinical Sciences at the Botnar Research Centre within the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences and chairs the NOCRI Translational Research Partnership. “The UK is an ideal place for medical research and development,” said Austen. “We have a cohesive, single payer system and our independent health and social care guidance body, NICE, has the important role through its medtech evaluation program of providing clinical excellence for our patients at the best possible price.” The ANS Neuroscan measures autonomic nervous system (ANS) status, which has been shown to influence many human immune functions at work in RA and in other autoimmune diseases. Through electrocardiogram (ECG) tracing, the ANS Neuroscan uses proprietary heart rate variability (HRV) technology to assess the patient’s ANS profile. Inmedix shared with NICE and NOCRI its published proof-of-concept study (n=33) of observed accuracy – with 90% sensitivity and 95.7% specificity – for the ANS Neuroscan to predict therapeutic biologic response for RA.1,2. At year one, 0% of patients with a baseline poor ANS profile achieved disease control using either etanercept (Enbrel®, Amgen) or adalimumab (Humira®, AbbVie). For patients with a baseline beneficial ANS profile, 65% achieved disease control as defined by an ACR70 response, a standard endpoint for measuring efficacy in RA. “We’re pleased to work with NIHR, NOCRI, and NICE as we address the goal of improving outcomes for patients with RA while reducing unsustainable costs,” said Andrew J. Holman, MD, CEO & Co-founder of Inmedix. “Conducting research in the UK single payer system will allow Inmedix to not only to seek greater rates of autoimmune disease remission, but to also assess the cost impact of reducing the need to so often escalate to biologic therapies.” According to Express Scripts, even though only 2 percent of the U.S. population uses biologic drugs, biologics account for 40 percent of prescription drug spending.3 RA affects nearly two million Americans, including children, at a tangible societal cost of $19.3 billion per year (2005 dollars).4 In the U.S., specialty pharmaceutical costs exceeded $87 billion in 2014, with rheumatologists responsible for 25%, mostly for biologic treatment of RA. The UK market is approximately one sixth the size of the U.S. market. Reducing the need to escalate to biologic care by enhancing non-biologic outcomes through ANS optimization strategies could potentially reduce specialty pharmacy costs for autoimmune diseases by 30-40%. About Inmedix, LLC Seattle-based biotech Inmedix is committed to engaging in world class research to discover innovative solutions for pressing healthcare needs related to the autonomic nervous system (ANS). Inmedix’s ANS Neuroscan is the leading heart rate variability (HRV) application as an informative diagnostic tool in autoimmune disease, beginning with patients with rheumatoid arthritis (RA). The company’s science and technology hopes to raise therapeutic outcomes so that patients will no longer need to cycle through failure of one therapeutic intervention after another. For more information, visit http://www.inmedix.com. References 1. Holman AJ, Ng E. Heart rate variability predicts anti-tumor necrosis factor therapy response for inflammatory arthritis. Autonomic Neurosci Basic Clinical 2008 Dec 5;143(1-2):58-67. 2. Holman AJ, Ng E. How substantive is Heart Rate Variability as a Predictor of Anti-TNF Treatment Outcome for Inflammatory Arthritis? Arthritis Rheumatol 2015;67(suppl 10). 3. Birnbaum H, Pike C, Kaufman R et al. Societal cost of rheumatoid arthritis patients in the US. Curr Med Res Opin 2010 Jan;26(1):77-90. 4. http://health.usnews.com/health-news/health-wellness/articles/2015/02/06/why-are-biologic-drugs-so-costly
News Article | May 18, 2017
The Canadian Institutes of Health Research (CIHR) has awarded a new CA$3.99 million grant to Gary Kobinger of Université Laval for work on a vaccine to prevent HIV infection. This three-year grant supports a scientific collaboration between Kobinger and the Design and Development Lab, a state-of-the-art research facility in Brooklyn, New York, operated by the International AIDS Vaccine Initiative (IAVI). Led by Kobinger and IAVI's Chris Parks, the respective Canadian and U.S. research teams aim to improve upon a promising HIV vaccine candidate designed by Parks, with the goal of advancing the candidate to clinical testing in human volunteers. "We are encouraged by this support of Gary Kobinger's work and the prospects of his collaboration with IAVI's Design and Development Lab," said Mark Feinberg, IAVI CEO. "The innovative work of the Kobinger lab provides a great illustration of how creative and insightful science can advance the global response to emerging infectious diseases, and exemplifies ways in which the benefits of research progress in one disease area can be translated to another, in this case, from an understanding of how to develop an effective Ebola vaccine to the ongoing search for an AIDS vaccine." Using a modified animal virus called Vesicular Stomatitis Virus (VSV) that does not cause disease in humans, the IAVI vaccine candidate delivers copies of a protein taken from HIV's surface. Once inside the body, the protein stimulates protective immune defenses against HIV infection. Studies in animals to date have yielded encouraging results. Kobinger's team will further modify the IAVI candidate vaccine for greater efficacy and clinical testing. An expert in the Ebola virus, Kobinger helped develop the Ebola (rVSV-ZEBOV) vaccine, which to date has proven the most effective at preventing Ebola infection, and which also uses a VSV backbone. "While there is still much work to be done, progress is being made towards finding a vaccine that will protect and eventually eliminate HIV/AIDS, one of the most serious health threats of our time," said Marc Ouellette, Scientific Director, Institute of Infection and Immunity, CIHR. In 2016, more than 2 million people were newly infected with HIV around the world. Though antiretroviral treatment has prolonged life for millions, scientists concur that discovering a vaccine against HIV is the only way to end the AIDS epidemic. By combining their expertise, CIHR and IAVI hope to advance the field of HIV vaccine discovery and to build a more efficient vaccine-development model that can potentially be replicated in other disease areas. Gary Kobinger is world-renowned for his work on the Ebola vaccine and treatment of those affected by the disease. More recently, while Chief of Special Pathogens with the Public Health Agency of Canada's microbiology laboratory in Winnipeg, Kobinger garnered international attention for his efforts to develop a treatment and vaccine against the Zika virus. ABOUT IAVI: Founded in 1996, the International AIDS Vaccine Initiative (IAVI) is a nonprofit organization working to accelerate development of broadly effective AIDS vaccines accessible to all. IAVI works with partners in 25 countries to research, design and develop promising vaccine candidates. We collaborate with governments, partner with pharmaceutical and bio-tech companies, universities, hospitals and civil society organizations, and conduct and support research in North America, Europe, Africa, and India. We strengthen the expertise and infrastructure to fight HIV/AIDS in sub-Saharan Africa, the epicenter of today's epidemic. And we advocate for policies, financing and environments that drive the fastest possible development of AIDS vaccines. Our vision is a world without AIDS, and that world has a vaccine. IAVI's work is made possible by generous support from many donors including: the Bill & Melinda Gates Foundation; the Ministry of Foreign Affairs of Denmark; Irish Aid; the Ministry of Finance of Japan in partnership with The World Bank; the Ministry of Foreign Affairs of the Netherlands; the Norwegian Agency for Development Cooperation (NORAD); the United Kingdom Department for International Development (DFID), and the United States Agency for International Development (USAID). The full list of IAVI donors is available at http://www. .
Ingram J.R.,Institute of Infection and Immunity |
Abbott R.,University of Wales |
Ghazavi M.,Nottingham Treatment Center |
Alexandroff A.B.,University of Leicester |
And 3 more authors.
British Journal of Dermatology | Year: 2014
Background Hidradenitis suppurativa (HS) has been neglected by medical researchers and society in general, despite being a relatively common, painful, chronic skin disease. Objectives To generate a top 10 list of HS research priorities, from the perspectives of patients with HS, carers and clinicians, to take to funding bodies. Methods A priority setting partnership was established between patients with HS, carers and clinicians, following the James Lind Alliance process. Survey 1 requested submission of HS uncertainties, which were grouped into 'indicative uncertainties' for prioritization in survey 2. The 30 highest-ranked indicative uncertainties were reduced to a 'top 10' list using nominal group technique at a prioritization workshop attended by all relevant HS stakeholders. Results In total 1495 potential uncertainties were submitted in survey 1, including 57% from patients with HS and carers, and grouped into 55 indicative uncertainties. Ranking in survey 2 was completed by 371 participants, 50% of whom were patients and carers. The final workshop was attended by 22 HS stakeholders and four facilitators and produced a top 10 list, the three highest priorities in descending order being (i) What is the most effective and safe group of oral treatments in treating HS? (ii) What is the best management of an acute flare? (iii)What is the impact of HS and its treatment on people with HS? Conclusions The top 10 HS research priorities have been directly disseminated to funders to raise awareness of HS. The next step is to generate research questions that will provide the evidence needed to improve care for patients with HS. What's already known about this topic? Hidradenitis suppurativa (HS) has been relatively neglected by society and medical research funding bodies, resulting in a lack of evidence to guide HS care. Obtaining research funding for HS is challenging. Priority setting partnerships can be used to raise awareness of a condition and demonstrate to funders and researchers the priorities of both patients and clinicians. What does this study add? Using transparent and inclusive James Lind Alliance methodology, a top 10 list of HS research priorities was identified, from the perspective of people with HS, their carers and the clinicians involved in their care. This process is important because of the large number of HS uncertainties that exist, and it will help researchers and medical funding bodies to decide which HS projects should be prioritized. © 2014 British Association of Dermatologists.
Ahmed Z.,Institute of Infection and Immunity |
Kawamura T.,Yamanashi University |
Shimada S.,Yamanashi University |
Piguet V.,Institute of Infection and Immunity
Journal of Investigative Dermatology | Year: 2015
Dendritic cells (DCs) and their subsets have multifaceted roles in the early stages of HIV-1 transmission and infection. DC studies have led to remarkable discoveries, including identification of restriction factors, cellular structures promoting viral transmission including the infectious synapse or the interplay of the C-type lectins, Langerin on Langerhans cells (LCs), and dendritic cell-specific intercellular adhesion molecule-3-grabbing non-integrin on other DC subsets, limiting or facilitating HIV transmission to CD4 + T cells, respectively. LCs/DCs are also exposed to encountering HIV-1 and other sexually transmitted infections (herpes simplex virus-2, bacteria, fungi), which reprogram HIV-1 interaction with these cells. This review will summarize advances in the role of DCs during HIV-1 infection and discuss their potential involvement in the development of preventive strategies against HIV-1 and other sexually transmitted infections. © 2015 The Society for Investigative Dermatology. © 2015 The Society for Investigative Dermatology.
Krishna S.,Institute of Infection and Immunity |
Ganapathi S.,St George's, University of London |
Ster I.C.,Institute of Infection and Immunity |
Saeed M.E.M.,Johannes Gutenberg University Mainz |
And 7 more authors.
EBioMedicine | Year: 2015
Background: Artesunate is an antimalarial agent with broad anti-cancer activity in in vitro and animal experiments and case reports. Artesunate has not been studied in rigorous clinical trials for anticancer effects. Aim: To determine the anticancer effect and tolerability of oral artesunate in colorectal cancer (CRC). Methods: This was a single centre, randomised, double-blind, placebo-controlled trial. Patients planned for curative resection of biopsy confirmed single primary site CRC were randomised (n. =. 23) by computer-generated code supplied in opaque envelopes to receive preoperatively either 14 daily doses of oral artesunate (200. mg; n. =. 12) or placebo (n. =. 11). The primary outcome measure was the proportion of tumour cells undergoing apoptosis (significant if >. 7% showed Tunel staining). Secondary immunohistochemical outcomes assessed these tumour markers: VEGF, EGFR, c-MYC, CD31, Ki67 and p53, and clinical responses. Findings: 20 patients (artesunate. =. 9, placebo. =. 11) completed the trial per protocol. Randomization groups were comparable clinically and for tumour characteristics. Apoptosis in >. 7% of cells was seen in 67% and 55% of patients in artesunate and placebo groups, respectively. Using Bayesian analysis, the probabilities of an artesunate treatment effect reducing Ki67 and increasing CD31 expression were 0.89 and 0.79, respectively. During a median follow up of 42. months 1 patient in the artesunate and 6 patients in the placebo group developed recurrent CRC. Interpretation: Artesunate has anti-proliferative properties in CRC and is generally well tolerated. © 2014.
PubMed | Johannes Gutenberg University Mainz, Institute of Tropical Medicine, Abel Salazar Biomedical Sciences Institute and Institute of Infection and Immunity
Type: | Journal: Pharmacological research | Year: 2016
Schistosomiasis is a helminthic disease affecting more than 200 million people in the tropics as well as returning travellers. Treatment mainly relies on a single drug, praziquantel. Praziquantel cannot kill developing schistosomula resulting in frequent treatment failures and re-infections. Monotherapy also favors the selection for resistance. New drugs are therefore urgently needed. The activity of the semi-synthetic artemisinin derivatives artemether, artesunate and arteether is not restricted to malaria. We reviewed their anti-schistosomal activity in vivo and in patients by searching the PubMed database for publications since 1983 with the search terms artemisinin and Schistosoma. Reports on in vivo studies in animals and clinical trials in human beings were selected. S. mansoni, S. japonicum, and S. haematobium have been tested in mice, rabbits, hamsters, and dogs. These artemisinin derivatives strongly reduced total worm rates with stronger reduction rates for female worms than for males. The drugs also reduced egg burden and egg-caused granulomata in the host liver. Artemisinin-type drugs induced oxidative and metabolic stress leading to morphological damage and decreased fertility of the parasites. Although artemether and artesunate have been investigated in numerous clinical trials, the poor quality of many has led to inconsistent results and has not provided convincing evidence on the therapeutic value against schistosomiasis. Despite these methodological concerns, clinical trials may indicate anti-schistosomal activity in patients. Convincing clinical trials providing unambiguous evidence are now needed. Furthermore, suitable treatment protocols for combination therapy to prevent/treat praziquantel-resistant Schistosoma strains should be investigated.