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News Article | April 17, 2017
Site: www.prweb.com

Board-certified internist and nephrologist Mark Pettus, MD joins the faculty of The American Meditation Institute (AMI) for a 30 credit hour mind/body medicine CME conference for physicians and other health care professionals, October 24-28, 2017 at the Cranwell Resort and Spa in Lenox, Massachusetts. Entitled "The Heart and Science of Yoga,” this 9th annual, comprehensive training, accredited through the American Medical Association and Albany Medical College Office of Continuing Medical Education, is designed to help prevent and relieve physician stress and burnout. Presenter Mark Pettus, MD currently serves as Medical Director of Education, Wellness and Population Health at Berkshire Health Systems, and Associate Dean of Medical Education at the University of Massachusetts Medical Center. A featured speaker on a number of nationally broadcast television and radio programs, Dr. Pettus is also the author of “The Savvy Patient” and “It’s All in Your Head: Change Your Mind, Change Your Health, & Change Your Life.” Dr. Pettus’s two lectures on ”Epigenomics and Inflammation” are designed to help relieve symptoms of physician and patient burnout by reducing allostatic load––the physiological consequences of chronic exposure to fluctuating or heightened neural or neuroendocrine responses resulting from chronic stress. Drawing on recent studies, Pettus will focus on how these areas of study are generating unprecedented medical understanding and insight into how AMI mantra meditation, gentle yoga and diaphragmatic breathing can have a fundamental influence on how our genes may express themselves. According to Dr. Pettus, “We’ve left behind the genetic perspective in which everything is preordained; the belief that whatever the translation of your genetic coding is, will manifest over the course of your life, and ultimately, there’s very little you can do about it. To the contrary, current clinical research is now suggesting a very, very different picture, in which genetic predisposition is no longer considered destiny.” The entire “Heart and Science of Yoga” CME curriculum is dedicated to providing quality, comprehensive and evidence-based education to physicians and other health care providers on Yoga Science as mind/body medicine. In addition to Epigenomics, topics this year will include mantra meditation, diaphragmatic breathing, Yoga Psychology, the chakra system as a diagnostic tool, mind function optimization, neuroplasticity, trauma, PTSD, relieving physician burnout, resilience, Functional Medicine, Ayurveda, easy-gentle yoga and lymph system detoxification. The dedication, enthusiasm, and teaching methodology of the entire AMI faculty create a dynamic and interactive course for their students. Each faculty member is committed to the advancement and training of Yoga Science as holistic mind/body medicine. In addition to Dr. Pettus, other presenters will include program director Leonard Perlmutter, AMI founder, meditational therapist, philosopher and award-winning author; Anthony Santilli MD, board-certified in Pulmonary and Critical Care Medicine; Prashant Kaushik MD, board-certified Rheumatologist; Sara Lazar PhD, instructor in the Department of Psychiatry at Harvard Medical School, and an Associate Researcher in the Psychiatry Department at Massachusetts General Hospital; Susan Lord MD, a private practice holistic physician focusing on prevention and treatment, and former course director for the The Center for Mind-Body Medicine’s “Food As Medicine” program in Washington, DC; Jesse Ritvo MD, Assistant Medical Director, Inpatient Psychiatry, University of Vermont Health Center; Beth Netter MD MT, holistic physician and acupuncturist, Albany, NY; Jyothi Bhatt BAMS, Ayurvedic practitioner and faculty member of Kripalu School of Ayurveda and Physician’s Assistant at New York Presbyterian/Weill Cornell Medical Center; and Gustavo Grodnitzky PhD, noted author and psychologist and Chair of The American Meditation Institute's Psychological Education Department; Jenness Cortez Perlmutter, faculty member of The American Meditation Institute. According to AMI founder and conference director Leonard Perlmutter, “The more consistently the therapeutic practices of meditation and yoga are incorporated into the daily lives of physicians and patients, most symptoms of stress related burnout and chronic complex diseases can be diminished or eliminated.” 2016 conference graduate, Janine Pardo, MD, a Board Certified Internist and Primary Care Physician practicing in Weston, Massachusetts fully commented, “This retreat has been the most influential factor in transforming my life and medical practice. It comprehensively provides critical information, and should be a medical school requirement.” Use this link to see this on facebook. About the American Meditation Institute The American Meditation Institute is a 501(c)3 non-profit educational organization devoted to the teaching and practice of Yoga Science, meditation and its allied disciplines as mind/body medicine. In its holistic approach to wellness, AMI combines the healing arts of the East with the practicality of modern Western science. The American Meditation Institute offers a wide variety of classes, retreats, and teacher training programs. AMI also publishes “Transformation” a bi-monthly journal of meditation as holistic mind/body medicine. Call 518.674.8714 for a mail or email subscription.


News Article | April 18, 2017
Site: www.prweb.com

To inspire other physicians who are experiencing the painful effects of stress, Dr. Prashant Kaushik will chronicle his own journey from burnout to homeostasis at the 9th annual CME Conference on Meditation and Yoga as Mind/Body Medicine, October 24-28, 2017 at the Cranwell Resort and Spa in Lenox, Massachusetts. Hosted by the American Meditation Institute and entitled “The Heart and Science of Yoga,” this comprehensive 30 credit-hour mind/body training on meditation, gentle yoga and diaphragmatic breathing, accredited through the Albany Medical College Office of Continuing Medical Education, is designed to help physicians and other healthcare professionals prevent and relieve burnout. Board-certified Rheumatologist Prashant Kaushik, MD knows all too well how the demands and stress of the medical profession can have a profound effect on the personal and professional lives of physicians and their patients. As a healthcare professional dedicated to expanding the current medical paradigm to include “self-care,” Dr. Kaushik will reveal how stress negatively affected his physical and mental wellbeing, and how he was able to transform his life with powerful AMI Meditation practices that reduce stress and enhance resilience and effectiveness. According to Dr. Kaushik, “Simple techniques like AMI mantra meditation, one-pointed attention, diaphragmatic breathing and easy-gentle yoga have been used for millennia to transform the debilitating nature of stress. When the practical tools of Yoga Science as mind/body medicine are incorporated into everyday life, physician burnout can be reversed dramatically and eliminated in many circumstances.” AMI faculty member Prashant Kaushik, MD received a Bachelor of Medicine & Surgery degree from the All India Institute of Medical Services, New Delhi. As a board-certified Rheumatologist, Dr. Kaushik serves as Lead Rheumatologist at the Albany VA Medical Center, Associate Professor, Department of Internal Medicine Albany Medical College, and is a member of the AMI Department of Medical Education. Dr. Kaushik is the 2015 recipient of the Albany Medical College’s Residency Teacher of the Year award. Defined as a “state of vital exhaustion” by the International Classification of Diseases, Tenth Edition, burnout in the medical profession has become a serious public health problem over the past decade. According to a March 2017 paper published on the National Academy of Medicine website, 54 percent of all physicians experience burnout (30–40 percent of employed physicians and 55–60 percent of self-employed physicians). Students, interns, and residents are close behind them, experiencing burnout at a rate of 20–40 percent. Recognizing this alarming trend, The American Meditation Institute is offering this unique mind/body medicine conference to help physicians alleviate their pain and enrich their health and wellbeing. Now in its ninth year of providing continuing medical education credits, the five-day retreat is carefully structured to optimize the experience of attendees. Each lecture is designed to reduce their allostatic load––the physiological consequences of chronic exposure to fluctuating or heightened neural or neuroendocrine responses resulting from chronic stress. The 30-hour CME comprehensive curriculum includes an in-depth study of the historical, philosophical and scientific nature of Yoga Science. Practical yogic skills will be taught to all attendees to expand their knowledge of and experience with health-affirming, yogic practices. Topics will include mantra-based AMI meditation, diaphragmatic breathing, Yoga Psychology, the chakra system as a diagnostic tool, mind function optimization, neuroplasticity, trauma, PTSD, Functional Medicine, Epigenomics, Ayurveda, nutrition, easy-gentle yoga and lymph system detoxification. An outstanding team of dedicated, enthusiastic, skilled health and wellness professionals, who draw on many years of experience in their respective fields, the AMI faculty will create a dynamic and interactive program for all attending medical professionals. In addition to Dr. Kaushik, this year’s presenters will include Leonard Perlmutter, AMI founder, philosopher, meditational therapist and award-winning author of “The Heart and Science of Yoga”; Mark Pettus MD, Director of Medical Education and Population Health at Berkshire Health Systems; Anthony Santilli MD, board-certified in Pulmonary and Critical Care Medicine; Sara Lazar PhD, neuroscientist at Beth Israel Deaconess Medical Center and instructor at Harvard Medical School; Susan Lord MD, a private practice holistic physician focusing on prevention and treatment, and former course director for the The Center for Mind-Body Medicine’s “Food As Medicine” program in Washington, DC; Jesse Ritvo MD, Assistant Medical Director, Inpatient Psychiatry, University of Vermont Health Center; Beth Netter MD MT, holistic physician and acupuncturist, Albany, NY; Jyothi Bhatt BAMS, Ayurvedic practitioner and faculty member of Kripalu School of Ayurveda and Physician’s Assistant at New York Presbyterian/Weill Cornell Medical Center; and Jenness Cortez Perlmutter, senior faculty member of The American Meditation Institute. According to Pamela Shervanick MD, who is a board certified psychiatrist in Barrington, Rhode Island and a recent AMI conference participant, “This conference has been life changing! Everyone in every facet of life should experience this. I’m so grateful for you and your institution and all involved for bringing truth to doctors with love and compassion. This is a light the world needs to see.” In addition to Dr. Shervanick, numerous medical pioneers and healthcare professionals such as Mehmet Oz MD, Dean Ornish MD and Bernie Siegel MD have also endorsed AMI’s core curriculum. Previous conference attendees have also noted that the material presented has made a beneficial impact toward their personal and professional efforts at self-care. About the American Meditation Institute The American Meditation Institute is a 501(c)3 non-profit educational organization devoted to the teaching and practice of Yoga Science, AMI meditation and its allied disciplines as mind/body medicine. In its holistic approach to wellness, AMI combines the healing arts of the East with the practicality of modern Western science. The American Meditation Institute offers a wide variety of classes, retreats, and teacher training programs. AMI also publishes Transformation a bi-monthly journal of meditation as holistic mind/body medicine. Call (518) 674-8714 for a mail or email subscription.


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


News Article | May 2, 2017
Site: www.prweb.com

According to Leonard Perlmutter, founder of The American Meditation Institute, the curriculum presented at AMI’s ninth annual CME conference October 24-28, 2017 at the Cranwell Resort and Spa in Lenox, Massachusetts can help physicians relieve and prevent burnout. Entitled “The Heart and Science of Yoga” this comprehensive 30 credit hour training is accredited through the Albany Medical College Office of Continuing Medical Education. In addition to a core Yoga Science curriculum including meditation, diaphragmatic breathing and gentle yoga exercises, three testimonial lectures will be presented by Tony Santilli MD, Beth Netter MD and Prashant Kaushik MD—each of whom has successfully used Yoga Science techniques to reduce and eliminate their own physicians burnout symptoms. Coverys Risk Management, reporting on Medscape’s Lifestyle Report 2017: Race and Ethnicity, Bias and Burnout reports that the overall burnout rate for physicians is now at 51 percent, an increase from 40 percent in 2013. The survey also found, “the highest percentages of burnout occurred among physicians practicing emergency medicine (59%), followed by ob/gyns (56%) and family physicians, internists, and infectious disease physicians (all at 55%).” This year’s American Meditation Institute “Heart and Science of Yoga” CME conference is dedicated to providing physicians a quality, comprehensive and evidence-based education that prevents and reverses the debilitating causes and effects of physician burnout. Lectures include mantra meditation, diaphragmatic breathing, easy-gentle yoga, Yoga psychology, meditation and neuroplasticity, PTSD, trauma, resilience, chakra system therapy, mind function optimization, epigenomics, Ayurveda, nutrition, functional medicine, and lymph system detoxification. According to previous conference attendee, board certified psychiatrist, Rebecca Aspden MD, “Since attending this retreat, my mind is open to a different way of seeing the world. I am looking forward to implementing what I learned in my own life and imparting this new knowledge and new perspective to my patients.” Each faculty member at this year’s CME conference is committed to the advancement and training of Yoga Science as holistic mind/body medicine. Presenters will include program director Leonard Perlmutter, AMI founder, meditational therapist and award-winning author; Mark Pettus MD, Director of Medical Education and Population Health at Berkshire Health Systems; Anthony Santilli MD, board-certified in Pulmonary and Critical Care Medicine; Prashant Kaushik MD, board-certified Rheumatologist; Sara Lazar PhD, instructor in the Department of Psychiatry at Harvard Medical School, and an Associate Researcher in the Psychiatry Department at Massachusetts General Hospital; Susan Lord MD, a private practice holistic physician focusing on prevention and treatment, and former course director for the The Center for Mind-Body Medicine’s “Food As Medicine” program in Washington, DC; Jesse Ritvo MD, Assistant Medical Director, Inpatient Psychiatry, University of Vermont Health Center; Beth Netter MD MT, holistic physician and acupuncturist, Albany, NY; Jyothi Bhatt BAMS, Ayurvedic practitioner and faculty member of Kripalu School of Ayurveda and Physician’s Assistant at New York Presbyterian/Weill Cornell Medical Center; Gustavo Grodnitzky PhD, noted author and psychologist and Chair of The American Meditation Institute's Psychological Education Department; and Jenness Cortez Perlmutter, faculty member of The American Meditation Institute. Noted physicians Mehmet Oz (Dr. Oz), Dean Ornish, Bernie Siegel and Larry Dossey have endorsed Mr. Perlmutter’s “The Heart and Science of Yoga” treatise, which serves as the primary curriculum for the conference. According to program director Leonard Perlmutter, “Now in its ninth year, this CME conference provides the only complete curriculum of the world’s most ancient mind/body medicine. The more physicians incorporate the therapeutic practices of Yoga Science and AMI Meditation into their daily lives, most symptoms of stress related burnout and chronic complex diseases can be diminished or eliminated.” About the American Meditation Institute The American Meditation Institute is a 501(c)3 non-profit educational organization devoted to the teaching and practice of Yoga Science, meditation and its allied disciplines as mind/body medicine. In its holistic approach to wellness, AMI combines the healing arts of the East with the practicality of modern Western science. The American Meditation Institute offers a wide variety of classes, retreats, and teacher training programs. AMI also publishes “Transformation” a bi-monthly journal of meditation as holistic mind/body medicine. Call 518.674.8714 for a mail or email subscription.


Mast cells, a type of white blood cell, are present in the airways of severe asthmatics even in the face of aggressive treatment, and their presence is associated with key indicators of severe asthma. It has long been thought that these mast cells contribute to the disease and that targeting them may improve symptoms and quality of life for patients with severe asthma. In a new, proof-of-principle study published in the New England Journal of Medicine, researchers from Brigham and Women's Hospital have found that targeting the mast cells with imatinib, a drug used to effectively treat certain forms of cancer, improved airway hyperresponsiveness, a measure of the sensitivity of the airway, and decreased the number of mast cells present in the airway. Treatment also produced a small improvement in airway function. "By targeting these mast cells, we can actually make a difference for our patients with severe asthma," said Elliot Israel, MD, a physician and researcher in the Division of Pulmonary and Critical Care Medicine at BWH and senior author of the paper. "This is an exciting development because patients with severe asthma often have poor disease control even when adhering to our best and most aggressive therapies." Imatinib (brand name Gleevec), is one of the first precision medicine cancer therapies and is currently used to effectively treat certain forms of cancer that have a specific mutation. It works by targeting the processes responsible for mast cell development, stem cell factor and its receptor, the KIT receptor tyrosine kinase, which are essential for not only normal mast cell development but also their survival. These new results suggest that KIT-dependent processes and mast cells contribute to the process of severe asthma, and suggest that imatinib and drugs that can inhibit mast cell development may be effective therapies for patients with severe asthma who do not respond well to current treatment options. "This study shows how the investigator community begins to apply knowledge of basic disease pathogenesis to tailor interventions to specific patient populations, which leads to more effective therapy. This is particularly the case for this patient group with a disease that is difficult to treat and that has a high morbidity rate," said James Kiley, Ph.D., director, Division of Lung Diseases, at the National Heart, Lung, and Blood Institute (NHLBI). In a double-blind, placebo-controlled 24-week trial of 62 participants with poorly-controlled severe asthma, researchers evaluated the impact of imatinib on the change in airway hyperresponsiveness and mast cell presence. Participants in the treatment group received imatinib for six months. Participants underwent a bronchoscopy with airway biopsy at the beginning and the conclusion of the study to assess airway mast cells. Airway responsiveness and airway function were also measured during the study. Israel and his colleagues report that patients in the treatment group experienced a reduction in airway hyperresponsiveness compared to placebo. Specifically, after three months, airway responsiveness decreased 50 percent in those treated with imatinib compared to those who received placebo. A similar degree of difference was seen between the groups at six months. Additionally, researchers found that imatinib reduced serum tryptase, a marker of mast cell activation, compared with placebo. Researchers also report that patients in the treatment group experienced a relaxation and opening up of the airways, which was an unexpected observation. Researchers note that patients in the treatment group experienced higher rates of muscle cramps and an abnormally low level of phosphate in the blood. While the results are preliminary, Israel and colleagues found that imatinib was more effective in patients who had less eosinophils, a type of disease-fighting white blood cell present in high numbers in certain types of severe asthma. "There are several new drugs for severe asthma that target the more allergic, or eosinophilic, type of severe asthma. If confirmed, our finding -- that targeting mast cells is effective for patients who do not have eosinophilic-type asthma -- is particularly exciting because this group of patients, which make up about 40 percent of patients with severe asthma, have no current treatment options to control their disease." Researchers note that larger-scale studies are needed to confirm their finding and evaluate longer durations of therapy in order to definitively determine clinical efficacy. Planning for these trials is underway.


News Article | May 19, 2017
Site: www.biosciencetechnology.com

A small clinical trial suggests that some patients with severe asthma may benefit from treatment with a targeted cancer drug. The study, conducted in part at Washington University School of Medicine in St. Louis, showed that imatinib (brand name Gleevec), commonly prescribed to treat chronic myeloid leukemia, also targets specific immune cells known to drive inflammation in the lungs. The results are published May 17 in The New England Journal of Medicine. “We are still in the early phase of this research,” said Washington University co-author Mario Castro, M.D., the Alan A. and Edith L. Wolff Professor of Pulmonary and Critical Care Medicine. “The data are intriguing and promising, but we will need a much larger trial, perhaps with 300-500 patients, over a longer period of time, to see if Gleevec can have an impact on asthma symptoms and quality of life.” The trial involved 62 patients treated at seven academic medical centers across the country and was led by Brigham and Women’s Hospital and Harvard Medical School. The researchers evaluated imatinib because it targets mast cells, which play a critical role in severe asthma. “In asthma, mast cells are key inflammatory cells that react to allergens and cause release of histamine and other mediators of inflammation,” Castro said. “Those contribute to our patients’ symptoms, including bronchospasm — a sudden contraction of the walls of the airway — wheezing and shortness of breath.” Castro said the trial was not large or long enough to determine whether patients experienced an improvement in symptoms, but the researchers did show that measures of airway inflammation were reduced in the patients receiving imatinib compared with a placebo. The patients in the trial were randomly assigned to receive imatinib or a placebo. The patients, their physicians and those analyzing the data did not know which patients received the drug and which received the placebo. Patients took the assigned drug or placebo daily. The trial lasted six months, with measures of asthma severity and airway inflammation taken at the beginning of the trial and at the three-month and six-month marks. Overall, patients taking imatinib performed better in assessments of airway reactivity and obstruction than patients receiving placebo. The improvement was modest, reaching statistical significance, but showing little evidence that clinical asthma symptoms had improved over the six months of the study. The researchers also measured lower blood levels of a chemical called tryptase in patients receiving imatinib compared with placebo. Tryptase is produced by mast cells, with lower amounts of it suggesting the drug is reducing inflammation mediated by this type of immune cell. Common treatments for asthma include inhaled steroids, which reduce all inflammation in a nontargeted way. In severe asthma, the steroid treatments often don’t control symptoms and the drugs have many side effects, especially for patients who have been taking them for many years. “A lot of patients with severe asthma have been taking high-dose steroids since childhood, and this long-term use has many negative consequences,” Castro said. “These patients are developing conditions like obesity, diabetes, high blood pressure and osteoporosis from their steroid use. And the steroids are not even effective in controlling their severe asthma.” Castro said the risks of taking a drug typically used for certain types of leukemia may be appropriate for patients with severe asthma if the drug provides the benefit of reducing or stopping steroid treatments. Though imatinib has a good safety record, it still raises concerns about suppressing the immune system. One patient stopped the trial because the white blood cell count became too low. Patients in the trial taking imatinib and placebo experienced similar numbers of adverse events, with adverse events due to asthma more common in the placebo group. Patients taking imatinib were more likely to experience muscle cramps and low blood phosphate levels. Three patients taking imatinib reported a total of seven severe adverse events. Five patients taking placebo reported 10 severe adverse events. When asthma-related adverse events were not counted in this total, there were five events reported in the imatinib group and three events in the placebo group.


Mast cells, a type of white blood cell, are present in the airways of severe asthmatics even in the face of aggressive treatment, and their presence is associated with key indicators of severe asthma. It has long been thought that these mast cells contribute to the disease and that targeting them may improve symptoms and quality of life for patients with severe asthma. In a new, proof-of-principle study published in the New England Journal of Medicine, researchers from Brigham and Women's Hospital have found that targeting the mast cells with imatinib, a drug used to effectively treat certain forms of cancer, improved airway hyperresponsiveness, a measure of the sensitivity of the airway, and decreased the number of mast cells present in the airway. Treatment also produced a small improvement in airway function. "By targeting these mast cells, we can actually make a difference for our patients with severe asthma," said Elliot Israel, MD, a physician and researcher in the Division of Pulmonary and Critical Care Medicine at BWH and senior author of the paper. "This is an exciting development because patients with severe asthma often have poor disease control even when adhering to our best and most aggressive therapies." Imatinib (brand name Gleevec), is one of the first precision medicine cancer therapies and is currently used to effectively treat certain forms of cancer that have a specific mutation. It works by targeting the processes responsible for mast cell development, stem cell factor and its receptor, the KIT receptor tyrosine kinase, which are essential for not only normal mast cell development but also their survival. These new results suggest that KIT-dependent processes and mast cells contribute to the process of severe asthma, and suggest that imatinib and drugs that can inhibit mast cell development may be effective therapies for patients with severe asthma who do not respond well to current treatment options. "This study shows how the investigator community begins to apply knowledge of basic disease pathogenesis to tailor interventions to specific patient populations, which leads to more effective therapy. This is particularly the case for this patient group with a disease that is difficult to treat and that has a high morbidity rate," said James Kiley, Ph.D., director, Division of Lung Diseases, at the National Heart, Lung, and Blood Institute (NHLBI). In a double-blind, placebo-controlled 24-week trial of 62 participants with poorly-controlled severe asthma, researchers evaluated the impact of imatinib on the change in airway hyperresponsiveness and mast cell presence. Participants in the treatment group received imatinib for six months. Participants underwent a bronchoscopy with airway biopsy at the beginning and the conclusion of the study to assess airway mast cells. Airway responsiveness and airway function were also measured during the study. Israel and his colleagues report that patients in the treatment group experienced a reduction in airway hyperresponsiveness compared to placebo. Specifically, after three months, airway responsiveness decreased 50 percent in those treated with imatinib compared to those who received placebo. A similar degree of difference was seen between the groups at six months. Additionally, researchers found that imatinib reduced serum tryptase, a marker of mast cell activation, compared with placebo. Researchers also report that patients in the treatment group experienced a relaxation and opening up of the airways, which was an unexpected observation. Researchers note that patients in the treatment group experienced higher rates of muscle cramps and an abnormally low level of phosphate in the blood. While the results are preliminary, Israel and colleagues found that imatinib was more effective in patients who had less eosinophils, a type of disease-fighting white blood cell present in high numbers in certain types of severe asthma. "There are several new drugs for severe asthma that target the more allergic, or eosinophilic, type of severe asthma. If confirmed, our finding - that targeting mast cells is effective for patients who do not have eosinophilic-type asthma - is particularly exciting because this group of patients, which make up about 40 percent of patients with severe asthma, have no current treatment options to control their disease." Researchers note that larger-scale studies are needed to confirm their finding and evaluate longer durations of therapy in order to definitively determine clinical efficacy. Planning for these trials is underway. Support for this study was provided by the NHLBI,the National Institute of Allergy and Infectious Diseases of the National Institutes of Health. ((NIH U01, HL102225, RO1 HL117945, RO1 AI078908, R37 AI052353, T32 AI007306-23, and K23 AI118804), and by contributions from the Vinik family and the Kaye family. Novartis provided imatinib free of charge and reviewed the protocol and the manuscript prior to submission but had no other role in the study.

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