News Article | May 9, 2017
Dr. McIntosh's platform presentation, on Thursday May 11th, at 12 p.m. entitled "HCP Analysis of a Variety of Biologics and Biosimilars using LC-MS/MS", will present Caprion's leading expertise using mass spectrometry workflows for the identification and quantitation of low abundance HCP in biopharmaceutical biological products. In addition, Dr. McIntosh will highlight Innovative approaches to analytical design, bioinformatics and tailored data interpretation with regards to HCP detection and monitoring. Dr. Schirm's presentation entitled "Data Analysis, Quantitation and Reporting for Mass Spectrometry-Based HCP Studies" will be held at the workshop at 4:30 p.m. on Wednesday May 10th and will provide an overview of case studies illustrating how data analysis, quantitation and reporting can be performed for various HCP applications, including characterization of in-process samples and bulk drug substance, comparability studies of biosimilars to innovators, and absolute quantification of HCP. ABOUT BIOLOGICS AND PROCESS-RELATED HCP IMPURITIES Host-cell proteins (HCP) constitute a major part of process-related impurities during biologics production and represent significant clinical safety risk associated to serious adverse events caused by immunogenicity. According to international guidelines issued by various regulatory agencies, rigorous and consistent methods to identify, measure and monitor residual HCP impurities should be implemented. Detecting low abundance HCP in drug substance (DS) remains a challenge which can be addressed with high sensitivity/high coverage characterization methods such as mass spectrometry, contributing to a robust, well-controlled and reproducible bioprocess. HCP impurities can now be readily identified and tracked with high sensitivity using Caprion's HCP DETECT Technology. Pre-Conference Workshop: Data Analysis, Quantitation and Reporting for Mass Spectrometry-Based HCP Studies Speaker: Michael Schirm, PhD, Associate Director, R&D Proteomics Pre-Conference, Wednesday, May 10th, 2017, 4:30 p.m. Platform Presentation: Lesson's Learned: HCP Analysis of a Variety of Biologics and Biosimilars using LC-MS/MS Speaker: Laura McIntosh, PhD, Vice-President of Translational Research Day 1, Thursday, May 11th, 2017, 12:00 p.m. For more information on the BEBPA conference, visit: http://www.bebpa.org/conferences/ To schedule a meeting with Dr. McIntosh at the event, please email: email@example.com ABOUT CAPRION BIOSCIENCES, INC. Founded in 2002, Caprion is a leading specialty CRO laboratory providing an integrated platform in proteomics and immune monitoring services to the pharmaceutical and biotechnology industry. Caprion's immune monitoring division, ImmuneCarta®, offers proprietary multiparametric flow cytometry services for functional analyses of innate and adaptive immune responses. Caprion's proteomics division, ProteoCarta™, offers proprietary gel-free, label-free mass spectrometry (MS) for comprehensive, quantitative and robust comparative measurement of proteins across large sets of biological samples for the discovery and validation of protein biomarkers. Based in Montreal, Canada, and in Gosselies, Belgium, Caprion has been providing large-scale proteomics and immune monitoring services to over 50 major pharmaceutical and biotech clients for more than 15 years. Caprion, a privately-held company, is majority owned by Global Healthcare Opportunities, or GHO Capital Partners LLP. For more information, please visit www.caprion.com
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 22, 2017
Bio-IT World also chose Linguamatics customer Pentavere Research Group as a Best Practices finalist, based on their work using I2E to mine unstructured data for real-world evidence to improve health outcomes. Best Practices finalists are recognized for their outstanding examples of technology innovation, from basic R&D to translational medicine. Pentavere deployed I2E to effectively mine unstructured EHR data, expediting delivery of their product daRWEn™ to the Real World Evidence market. "The annual Bio-IT World Conference & Expo is a premier event in the life sciences industry and we are honored to be considered a Best of Show Award contender," said Phil Hastings, Linguamatics chief business development officer. "We are also proud to feature in the Best Practices awards program through Pentavere's use of I2E, and congratulate them for being named a finalist." Since its debut in 2002, the Bio-IT World Conference & Expo has showcased the myriad of IT and informatics technologies that drive biomedical research, drug discovery and development, and clinical and healthcare initiatives. This year marks Linguamatics' 12th consecutive year as a conference participant and exhibitor. The 2017 conference features over 200 technology and scientific track sessions, including a presentation by Linguamatics CTO David Milward, Ph.D., on Wednesday May 24 at 12pm ET. During the Clinical Research and Translational Informatics track, Dr. Milward will discuss how text mining extracts and connects relevant clinical and scientific data in a session entitled, "Text Mining in Translational Research: Bench to Bedside and Back Again." During his talk Dr. Milward will highlight Eli Lilly's use of I2E for systematic drug repositioning from clinical trial records. Linguamatics Life Science platform uses advanced NLP to transform unstructured text into structured data. I2E 5.0 provides major new enhancements, including powerful concept normalization, advanced range search, and a new query language. These capabilities tackle the variety in big data to provide insights from the estimated 80% of data trapped in unstructured text, as well as from semi-structured and structured data sources. Linguamatics will provide demonstrations of its new I2E 5.0 release at Booth 345. Linguamatics transforms unstructured big data into big insights to advance human health and wellbeing. A natural language processing (NLP)-based text mining leader, Linguamatics' solutions are used by top commercial, academic and government organizations for high-value knowledge discovery and decision support, including 18 of the top 20 global pharmaceutical companies and leading US healthcare organizations. Linguamatics I2E mines a wide variety of text resources, including scientific literature, patents, Electronic Health Records (EHRs), clinical trials data, news feeds and proprietary content. I2E can be deployed as an in-house enterprise system or as Software-as-a-Service (SaaS). To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/linguamatics-to-highlight-new-text-analytics-technologies-and-innovative-deployments-at-bio-it-world-2017-300461026.html
News Article | May 22, 2017
As represented by conventional radiograph, radiological images provide only black and white figures in 2D space. The situation is basically the same for Single photon emission tomography (SPECT) and positron emission tomography (PET), which are the two most common molecular imaging techniques used in nuclear medicine. PET is used especially for early cancer and Alzheimer's disease detection, but radioactive tracers suitable for each detector are limited in terms of energy. For example, PET can only image monochromatic gamma rays thus provide black and white 2D images. Moreover, production of PET tracers, usually made by a cyclotron facility in medical centers, is inevitably costly. "All of these problems could be addressed if gamma rays of arbitrary energy could be easily visualized in 3D space," points out Jun Kataoka, professor of applied physics at Waseda University. "This would be as revolutionary as black and white television turning into color, dramatically increasing the amount of information we could obtain from an image." Thus, Professor Kataoka's research group invented a medical gamma-ray detector (Compton camera) and succeeded in high-resolution, multicolor 3D molecular imaging of a live mouse which was administered with three different radioactive tracers. They discovered that the tracers iodine, strontium, and zinc accumulated in the thyroid, bones and liver respectively, confirming that these new tracers concentrated in each target organ. What's more, this camera only weighs 580g and fits in the palm of a hand, making it the world's most compact Compton camera. "The measurement time took 10 minutes per angle, so we were able to obtain an image taken from 12 angles in just 2 hours. The time could be reduced even more by using multiple Compton cameras. For example, if there are 12 Compton cameras surrounding an object, the same image as this study could be obtained in just 10 minutes, suggesting a new way to understand biodynamics by looking at how a drug is taken into the body in 10-minute increments." This research was published in Scientific Reports. Although SPECT and PET are widely used, the radioactive tracers suitable for each detector have been limited. SPECT only images low-energy gamma rays less than 400 kilo-electron volts (keV), and PET can image only positron emitting sources of 511keV. Thus, the use of a Compton camera, which can image energy from a few hundred keV to more than mega-electron volts (MeV), was eagerly awaited for, along with development of new potential tracers. Professor Kataoka's research group developed the world's lightest, medical Compton camera with high detection efficiency and practical spatial resolution, enabling flexible measurements. The camera was then rotated around the mouse from 12 angles, which was administered with three different radioactive tracers: iodine (131I, 364 keV), strontium (85Sr, 514 keV), and zinc (65Zn, 1116 keV). The measurement time totaled 2 hours, and the group successfully demonstrated the effectiveness of simultaneous in vivo imaging of multiple tracers and imaged the gamma rays nearly real-time with a resolution of 3mm, equivalent to PET. Based on this study, Professor Kataoka is now working towards developing a gamma-ray camera which works like the human eye. "The human eye can instantly distinguish the colors and brightness of light from all directions, as well as determine the object's shape in 3D from the displacement between the left and right eye. Therefore, stereoscopic imaging becomes theoretically feasible by using multiple ultra-compact Compton cameras." Though not limited to the medical field, this technology could help track behaviors of cancer cells and minerals in the body by combining the conventional PET drugs with newly found tracers, calculate the survival rate of a transplanted organ, develop cheaper and more convenient drugs for medical imaging, and monitor online the effectiveness of particle therapy by measuring various prompt gamma rays emitted during treatment. "As radiation technology is still emerging, we look forward to expanding the possibilities of next-generation radiation imaging with this 'on demand' Compton camera," Professor Kataoka says. *All of the animal experiments were approved by the animal ethics committees of Osaka University and were performed according to the institutional guidelines. Title: First demonstration of multi-color 3D in vivo imaging using ultra-compact Compton camera Published in: Scientific Reports Authors: Aya Kishimoto (1), Jun Kataoka (1), Takanori Taya (1), Leo Tagawa (1), Saku Mochizuki (1), Shinji Ohsuka (2), Yuto Nagao (3), Keisuke Kurita (3), Mitsutaka Yamaguchi (3), Naoki Kawachi (3), Keiko Matsunaga (4), Hayato Ikeda (4), Eku Shimosegawa (4), and Jun Hatazawa (4) 1. Graduate School of Advanced Science and Engineering, Waseda University, Tokyo, Japan 2. Central Research Laboratory, Hamamatsu Photonics K.K., Shizuoka, Japan 3. National Institutes for Quantum and Radiological Science and Technology, Gunma, Japan 4. Medical Imaging Center for Translational Research, Osaka University Graduate School of Medicine, Osaka, Japan Waseda University is a leading private, non-profit institution of higher education based in central Tokyo, with over 50,000 students in 13 undergraduate and 21 graduate schools. Founded in 1882, Waseda cherishes three guiding principles: academic independence, practical innovation and the education of enlightened citizens. Established to mold future leaders, Waseda continues to fulfill this mission, counting among its alumni seven prime ministers and countless other politicians, business leaders, journalists, diplomats, scholars, scientists, actors, writers, athletes and artists. Waseda is number one in Japan in international activities, including number of incoming and outgoing study abroad students, with the broadest range of degree programs taught fully in English, and exchange partnerships with over 600 top institutions in 84 countries.
News Article | April 26, 2017
AURORA, Colo. (April 26, 2017) - Using a unique microscope capable of illuminating living cell structures in great detail, researchers at the University of Colorado Anschutz Medical Campus have found clues into how a destructive autoimmune disease works, setting the stage for more discoveries in the future. The scientists were trying to visualize antibodies that cause neuromyelitis optica (NMO), a rare autoimmune disorder that results in paralysis and blindness. Using a custom STED (Stimulated Emission Depletion) microscope built at CU Anschutz, they were able to actually see clusters of antibodies atop astrocytes, the brain cell target of the autoimmune response in NMO. "We discovered that we could see the natural clustering of antibodies on the surface of target cells. This could potentially correspond with their ability to damage the cells," said Professor Jeffrey Bennett, MD, PhD, senior author of the study and associate director of Translational Research at the Center for NeuroScience at CU Anschutz. "We know that once antibody binds to the surface of the astrocyte, we are witnessing the first steps in the disease process." When that domino effect begins, it's hard to stop. But Bennett said the ability to see the antibodies on the brain cells offers a chance to develop targeted therapies that do not suppress the body's immune system like current treatments for the disease do. "By applying this novel approach we can see firsthand how these antibodies work," said the study's lead author, John Soltys, a current student in the Medical Scientist Training Program at CU Anschutz. "We are looking at the initiation of autoimmune injury in this disease." The breakthrough was made possible with the STED microscope, a complex instrument that uses lasers to achieve extreme precision and clarity. It was built by physicist Stephanie Meyer, PhD, at CU Anschutz. This is the first time it has been used in a research project here. "This would have been impossible to see with any kind of normal microscope," said study co-author Professor Diego Restrepo, PhD, director of the Center for NeuroScience. "We are inviting other scientists with research projects on campus to use the STED microscope." According to Meyer, lower resolution microscopes are blurrier than the STED due to diffraction of light. But the STED's lasers illuminate a smaller area to acquire a higher resolution image. Unlike electron microscopes, STED users can see entire living cells at extremely high resolution, as they did in this study. Restrepo said there are only a handful of STEDs in the nation and just one in Colorado. The researchers said the discovery is the result of a unique partnership between clinical neurology, immunology and neuroscience coming together to solve a fundamental question of how antibodies can initiate targeted injury in an autoimmune disease. "These are the building blocks that we can use to carry our research to the next level," Bennett said. The study was published this week in Biophysical Journal.
News Article | April 26, 2017
A new type of microscope, capable of illuminating living cell structures in clear detail, could provide insight into autoimmune diseases and lead to new treatment options. Researchers from the University of Colorado Anschutz Medical Campus believe this new tool— a custom Stimulated Emission Depletion (STED) microscope—could set the stage for future treatment discoveries and visualize antibodies that cause the rare autoimmune disorder neuromyelitis optica, which can result in paralysis and blindness. The researchers used the microscope to actually see the clusters of antibodies atop astrocytes—the brain cell target of the autoimmune response in the disease. “By applying this novel approach we can see firsthand how these antibodies work,” the study's lead author, John Soltys, a current student in the Medical Scientist Training Program at CU Anschutz, said in a statement. “We are looking at the initiation of autoimmune injury in this disease.” Dr. Jeffrey Bennett, Ph.D., the senior author of the study and the associate director of Translational Research at the Center for NeuroScience at CU Anschutz, explained that the microscope allows researchers to view the early stages of various diseases as they form. “We discovered that we could see the natural clustering of antibodies on the surface of target cells,” Bennett said in a statement. “This could potentially correspond with their ability to damage the cells. “We know that once antibody binds to the surface of the astrocyte, we are witnessing the first steps in the disease process,” he added. According to Bennett, the ability to see the antibodies on the brain cells offers researchers an opportunity to develop targeted therapies that do not suppress the body’s immune system like some current treatments for the disease do. The STED microscope—which was built by CU Anschutz physicist Stephanie Meyer, Ph.D.—uses lasers to achieve a higher level of precision and clarity. Lower resolution microscopes are blurry because of the diffraction of light. However, the lasers illuminate a smaller area to acquire a higher resolution image than traditional microscopes. The STED microscope can also highlight entire living cells at extremely high resolution, unlike electron microscopes. “This would have been impossible to see with any kind of normal microscope,” professor Diego Restrepo, Ph.D., director of the Center for NeuroScience and study co-author, said in a statement. “We are inviting other scientists with research projects on campus to use the STED microscope.” The study was published in Biophysical Journal.
News Article | April 18, 2017
The MIT Center for Environmental Health Sciences (CEHS), an interdisciplinary research center, funded by the National Institute of Environmental Health Sciences (NIEHS), invites MIT junior faculty and research staff with principal investigator privileges to submit applications for funding of pilot projects related to environmental health, to support either basic or translational research. Please see the NIEHS strategic plan to gain understanding of the types of projects center plans to fund. Preference is given to projects that address the NIEHS Strategic Goals. The center anticipates funding of $25,000 (direct costs) for each project. The center encourages junior faculty to apply, especially those who are involved in interdisciplinary environmental health collaborations, for example between engineers and scientists. Projects can be anywhere on the spectrum between basic sciences and clinical translation. In all cases, the trajectory to human application must be clear and feasible. Translational Pilot Projects will be evaluated separately from those in the basic sciences. These projects are funded through the generosity of Vilma and Lionel Kinney, and are named in honor of Theron G. Randolph, a pioneer in the fields of environmental and natural products medicine. Applicants should submit a four-page research plan that outlines the specific aims and research strategy (i.e. significant, innovation, and approach). In the project title, please add a parenthesis indicating (Basic Research) or (Translational Research). Applications should also include a detailed budget form (Form Page 4), budget justification, and a biographical sketch using the NIH PHS398 forms. Please note that travel for scientific conferences/meetings are not allowed with these funds. Questions regarding the application process or proposal ideas should be directed to Professor Bevin P. Engelward, deputy director. Deadline for this call is May 31 with an anticipated start date of July 1. Completed applications should be submitted via email to: Amanda Tat, administrative officer of the CEHS.
News Article | April 27, 2017
Boston, MA-- A new study led by researchers at Brigham and Women's Hospital has found that a single measurement of plasma glycated CD59 (GCD59), a novel biomarker for diabetes, at weeks 24-28 of gestation identified, with high sensitivity and specificity, women who failed the glucose challenge test as well as women with gestational diabetes. Plasma levels of GCD59 were also associated with the probability of delivering a large-for-gestational-age newborn. These findings are published in Diabetes Care. Gestational diabetes is a type of diabetes that occurs during a woman's pregnancy, increasing the mother's risk of delivering a large-for-gestational-age baby, which can lead to pre-term birth, fetal injury, perinatal mortality and cesarean delivery. Gestational diabetes is also a risk factor for preeclampsia and gestational hypertension. Since treatment of gestational diabetes can lessen the risk of adverse pregnancy outcomes, practice guidelines recommend screening all non-diabetic, pregnant women for the disease. The current standard of care to both screen and diagnose gestational diabetes predominantly involves a two-step approach. The first step, known as the glucose challenge test, includes administration of a sugary drink followed by a blood sugar measurement one hour later. Women who fail this screening are then sent for a longer test, called the oral glucose tolerance test, which requires fasting overnight, drinking a more concentrated sugar solution and undergoing baseline and hourly blood draws for three hours. These glucose tests, or variations thereof, are currently the only methods used to screen pregnant women for or diagnose gestational diabetes. They are time consuming, cumbersome, uncomfortable for mothers and have poor reported reproducibility. The research team's primary goal was to assess the accuracy of the diabetes biomarker, GCD59, in predicting the results of the standard of care glucose challenge test used to screen for gestational diabetes. The team conducted a case-control study of 1,000 pregnant women who were receiving standard prenatal care at BWH: 500 women who had a normal glucose challenge test (control subjects) and 500 women who failed the glucose challenge test and required a subsequent oral glucose tolerance test (case patients). Researchers found that, when compared with the control subjects, the median plasma GCD59 value was 8.5-fold higher in the patients who failed the glucose challenge test and 10-fold higher in the subset of these patients who met diagnostic criteria for gestational diabetes in the subsequent oral glucose tolerance test. "This is the first study to demonstrate that a single measurement of plasma GCD59 can be used as a simplified method to identify women who are at risk for failing the glucose challenge test and are at higher risk for developing gestational diabetes," says Jose Halperin, MD, a physician and researcher, Director of the Hematology Laboratory for Translational Research at BWH and senior author of the publication. The researchers also found that higher plasma GCD59 levels at gestational week 24-28 were associated with higher prevalence of large-for-gestational-age newborns, with the higher the level, the higher the risk (4 percent higher risk for patients in the lowest quartile of GCD59 plasma levels, and 14 percent in the highest quartile). Out of the 58 large-for-gestational-age babies born to mothers that failed the glucose challenge test in this study, 80 percent were born to mothers who did not meet oral glucose tolerance test criteria for gestational diabetes, but had median plasma GCD59 levels 7-fold higher than control women with a normal glucose challenge test. These findings are consistent with other studies showing that women who fail the glucose challenge test, but do not meet criteria for gestational diabetes, are still at a higher risk of abnormal pregnancy outcomes, including delivering large for gestational age babies. Currently there are no practice guidelines for the management of women who fall between normal and abnormal glucose tolerance levels, and, therefore, their management is the same as that for women with a normal glucose challenge test results. "These results suggest that a single measurement of plasma GCD59 during weeks 24-28 may also help stratify the risk for delivering larger infants among women with gestational glucose intolerance." says Halperin. "Our studies opened an avenue for larger multicenter studies to further assess the clinical utility of plasma GCD59 for screening and diagnosis of gestational diabetes among the general population of the United States. If our results are confirmed, we're hopeful that the GCD59 test could be available in clinical practices within the next few years." Jose Halperin and Michael Chorev have a financial interest in Mellitus, LLC, which is developing diagnostic tools for diabetes, including the test described in this research under a license agreement from Harvard University. This project was supported by the National Institutes of Health grants DK-095429, DK-62994, DK-089206, DK-101442, DK-107407, and HL-111771. It was also funded by the Harvard University Accelerator Fund, now known as the Blavatnik Biomedical Accelerator at Harvard University and the Doris Duke Charitable Foundation. Paper cited: Halperin et al. "Plasma Glycated CD59, a Novel Biomarker for Detection of Pregnancy-Induced Glucose Intolerance." Diabetes Care DOI: 10.2337/dc16-2598. Brigham and Women's Hospital (BWH) is a 793-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare. BWH has more than 4.2 million annual patient visits and nearly 46,000 inpatient stays, is the largest birthing center in Massachusetts and employs nearly 16,000 people. The Brigham's medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in patient care, quality improvement and patient safety initiatives, and its dedication to research, innovation, community engagement and educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Brigham Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, more than 3,000 researchers, including physician-investigators and renowned biomedical scientists and faculty supported by nearly $666 million in funding. For the last 25 years, BWH ranked second in research funding from the National Institutes of Health (NIH) among independent hospitals. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative as well as the TIMI Study Group, one of the premier cardiovascular clinical trials groups. For more information, resources and to follow us on social media, please visit BWH's online newsroom.
News Article | May 4, 2017
Eiger management will provide an update on enrollment in the Phase 2 LIBERTY study of ubenimex for the treatment of PAH and announce timelines and plans for topline data. "Inflammation is now recognized as an important component of PAH which is not addressed by currently available therapies," said Mark Nicolls, MD, Chief of Pulmonary and Critical Care Medicine at Stanford University School of Medicine. "Our recently published preclinical studies suggest that elevated LTB levels may play a role in the inflammatory component of PAH, which can lead to obstructed arterioles, vasoconstriction, and worsening cardiac function. Targeted LTB blockade may represent an important new therapeutic approach to PAH disease." "The LIBERTY study represents a clinical translational effort with potential for disease modification in PAH," said Roham Zamanian, MD, Lead Investigator and Director of the Adult Pulmonary Hypertension Program at Stanford University School of Medicine. "While currently approved vasoactive agents have utility in the clinical management of the symptoms of PAH, they do not address the underlying inflammation which is an important signature of this cardiovascular disease. We have arrived at a moment of shift of therapeutic paradigm, where we may have a chance to realize a potentially disease modifying approach." Dr. Mark Nicolls is a practicing pulmonologist and investigator, and the Chief of the Division of Pulmonary and Critical Care Medicine at Stanford as well as the Director of Lung Immunology. He holds an endowed Chair of Medicine (The Stanford Chair of Pulmonary and Critical Care Medicine), is an elected member of the American Society for Clinical Investigation (ASCI), and is a permanent standing member on the NIH study section RIBT (Respiratory Integrative Biology and Translational Research Study Section). He is an NIH-funded investigator whose laboratory focuses on the contribution of immunity in vascular injury in pulmonary hypertension, lung transplantation and lymphedema. Dr. Nicolls leads the first NIH trial of immunotherapy as a treatment for pulmonary arterial hypertension (PAH). Dr. Roham Zamanian is Associate Professor of Medicine in the Division of Pulmonary and Critical Care Medicine, Director of the Adult Pulmonary Hypertension Program at Stanford University School of Medicine, and a faculty member of the Vera Moulton Wall Center for Pulmonary Vascular Disease. He has been the Director of the Adult Pulmonary Hypertension (PH) Program since 2007. The Stanford Adult Pulmonary Hypertension Program evaluates and treats approximately 600-700 PH patients annually. Besides an active clinical career, Dr. Zamanian is extensively engaged in clinical translational research. He directs the Vera Moulton Wall Center clinical database and biobank and focuses his research on clinical characterization and impact of novel risk factors such as methamphetamine use, and biomarkers, such as insulin resistance, in PAH. Dr. Zamanian has re-focused the research mission of the Stanford PH program by collaborating with basic science faculty and implementing several proof-of-concept and phase II clinical trials of novel therapeutics developed at Stanford University. This event is intended for institutional investors, sell-side analysts, investment bankers, and business development professionals only. Please RSVP in advance if you plan to attend, as space is limited. To reserve a spot, please contact LifeSci Advisors, LLC at Mac@LifeSciAdvisors.com. A live and archived webcast of the event, with slides, will be available at http://lifesci.rampard.com/20170510/reg.jsp and on the Investors section of the Eiger website at www.eigerbio.com. LIBERTY is a multi-center, randomized, double-blind, placebo-controlled Phase 2 study of ubenimex in patients with PAH. Patients are randomized in a 2:1 ratio to receive ubenimex or matching placebo, administered orally for a total of 24 weeks. Patients who complete treatment through Week 24 are eligible to enroll in an open-label extension study to receive continued treatment. This open-label extension will allow all patients the option to receive ubenimex for at least 24 additional weeks and provide additional data on safety, tolerability and efficacy. LTB is a naturally-occurring inflammatory mediator shown to be elevated in both animal models of PAH as well as human PAH disease. Published preclinical results of studies conducted at Stanford University suggest that elevated LTB levels may play a role in the inflammatory component of PAH, which can lead to obstructed arterioles, vasoconstriction, and worsening cardiac function. Targeted LTB blockade may represent an important new therapeutic approach to this disease. Ubenimex is a well-characterized, oral, small-molecule, inhibitor of LTA H, the enzyme responsible for the formation of the pro-inflammatory mediator, LTB . Ubenimex is approved in Japan (brand name Bestatin™) as an adjunct to chemotherapy agents to extend survival and to maintain remission after treatment for acute non-lymphocytic leukemia in adults. Ubenimex has been used for over 25 years in Japan and remains commercially available through Nippon Kayaku. Ubenimex has been granted Orphan Drug Designation for treatment of PAH by the US FDA and European Medicines Agency (EMA). Ubenimex is not approved for any indication in the US or Europe. Pulmonary arterial hypertension (PAH) is a type of high blood pressure that affects the arteries in the lungs and the right side of the heart. PAH begins when tiny arteries in the lungs, called pulmonary arterioles, become narrowed, blocked or destroyed. This makes it harder for blood to flow through the lungs, and raises pressure within the lungs' arteries. As the pressure builds, the heart's lower right chamber (right ventricle) must work harder to pump blood through the lungs, eventually causing the heart muscle to weaken and eventually fail. PAH is a progressive, life-threatening illness. Eiger is a clinical-stage biopharmaceutical company committed to bringing to market novel products for the treatment of rare diseases. The company has built a diverse portfolio of well-characterized product candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which an effective therapy is urgently needed. For additional information about Eiger and its clinical programs, please visit www.eigerbio.com. Note Regarding Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives, intentions, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "project," "target," "will" and other words and terms of similar meaning. Examples of such statements include, but are not limited to, whether or not pegylated interferon lambda-1a or lonafarnib or ubenimex or exendin 9-39 may be further developed and approved, and whether promising earlier clinical study results will be repeated in larger, later clinical studies, statements relating to the availability of cash for Eiger's future operations, Eiger's ability to develop its drug candidates for potential commercialization, the timing of the commencement and number and completion of Phase 2 trials and whether the products can be successfully developed or commercialized. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Eiger makes, including the risks described in the "Risk Factors" sections in the Annual Report on Form 10-K for the period ended December 31, 2016 and Eiger's periodic reports filed with the SEC. Eiger does not assume any obligation to update any forward-looking statements, except as required by law. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/eiger-biopharmaceuticals-to-host-key-opinion-leader-event-addressing-need-for-novel-mechanisms-in-the-treatment-of-pulmonary-arterial-hypertension-pah-on-may-10th-in-new-york-city-300451286.html