News Article | May 18, 2017
SAN DIEGO--(BUSINESS WIRE)--Aries Pharmaceuticals, Inc. (Aries), a specialty pharmaceutical company commercializing best-in-class gastroenterology products, shared positive results of the first Eleview™ clinical trial in humans at the annual Digestive Disease Week (DDW) conference in Chicago, Illinois earlier this month. Eleview is a novel, ready to use, methylene blue containing, submucosal injectable composition for use in the easy and safe endoscopic removal of polyps, adenomas, and early stage cancers, and other lesions in the gastrointestinal (GI) tract. The product, which is packaged as a set of five 10 mL single use, sterile ampoules with a luer lock closure that can easily be connected to a suitable syringe, was also unveiled for the first time. The “Twist and Go” ampoules enable endoscopists to quickly access Eleview when needed without having to wait for compounding and eliminate product waste should a lesion not be identified during the procedure. Eleview is administered through an endoscope via a normal, commercially available endoscopic injection needle. The goals of the study were to assess the comparative effectiveness and safety of Eleview versus standard saline plus methylene blue (saline admixture) in patients undergoing Endoscopic Mucosal Resection (EMR) of colonic lesions ≥20 mm. While not powered for statistical significance, several efficacy endpoints did demonstrate significance and all others trended positively for Eleview. Data presented at the meeting positively demonstrated both efficacy and safety for Eleview when compared to saline plus methylene blue. The three primary efficacy endpoints were all positive for the Eleview arm of the study: Secondary efficacy endpoints also demonstrated relative improvement for the Eleview arm of the study: The safety data is interim given that some patients have not yet reached their 60-day post-procedure follow-up exam. To date, no substantial differences in the number of complications between Eleview and the comparator saline admixture arm were seen. The study results so far suggest that Eleview is at least as safe as the comparator saline in terms of procedural complications. “ The results of this study helped to demonstrate clear procedural advantages over saline and that’s great news for patients and clinicians -- and potentially also the healthcare system,” noted David Kriesel, Executive Director of Medical Affairs. “ A key differentiator for Eleview is the fact that it’s premixed and ready-to-use. Unlike the current standard of care of saline admixed with methylene blue and/or other components, Eleview’s convenient ready-mixed packaging can save procedure time by not having to order the admixture to be compounded either before or during the procedure. We’re excited to now offer the product in the United States, and look forward to working with endoscopists to increase access nationwide.” The study helps to reinforce the benefits Eleview presents for gastroenterologists and patients. Upon injection, the product forms an immediate cushion of optimal shape, height, and duration. The inclusion of methylene blue, a contrast dye, improves visibility of the lesion. By providing an immediate and long-lasting cushion beneath the polyp and improving the visibility of the lesion, Eleview helps endoscopists achieve a complete and safe removal of the lesion. When compared to saline, one of the most commonly used agents and used as the comparator arm with the addition of methylene blue in the above study, Eleview demonstrated better cushion-forming ability and a duration of lift of up to 45 minutes. In addition to potential time savings gained from the premixed formulation and a more rapid lesion removal, costs savings may also be seen if there are shortened procedural times, which could also positively impact patient sedation time, endoscopy suite utilization, and personnel costs per procedure. Additional studies are being considered to confirm these assumptions. About the Study This first-in-human study was a randomized, double blind, multicenter clinical trial with parallel arms with sites in the United States and Europe. 211 patients were included in the primary analysis. The mean lesion size in the Eleview arm was 31.64 mm. In the comparator saline arm, the mean lesion size was 32.31 mm. The data set was presented at Digested Disease Week (DDW) on May 8, 2017 by one of the principal investigators, Dr. Douglas Rex from Indiana University Hospital, Indianapolis, Indiana. Additional principal investigators include: Mike Wallace from Mayo Clinic, Jacksonville, Florida; Prateek Sharma, University of Kansas Medical Center, Kansas City, Kansas; Alessandro Repici, Humanitas Research Hospital, Milan, Italy; and Pradeep Bhandari, Solent Center for Digestive Diseases, Portsmouth, United Kingdom. The clinical trial was sponsored by Cosmo Pharmaceuticals, N.V. (SIX: COPN) (Cosmo), the developer of Eleview. About Eleview™ Eleview submucosal injectable composition is intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device. Developed by Cosmo, Eleview has been 510(k) cleared by the FDA as a class ll medical device and is the only commercially available medical device for this indication. Additional product information at EleviewUS.com. Eleview is available now for order at 888-ARIES-08. CONTRAINDICATIONS Patients with known sensitivity to any of the components contained in Eleview. Please see Instructions for Use for complete Important Safety Information. About Aries Pharmaceuticals, Inc. Aries Pharmaceuticals, Inc. (Aries) is a specialty pharmaceutical company commercializing best-in-class gastroenterology products for the United States market with a focus on products utilized in endoscopy and for the treatment of specific gastrointestinal diseases. The company’s initial portfolio of four products, three of which are still in development, are licensed from Cosmo Pharmaceuticals N.V. to Aries Ltd. Aries is the US distribution arm of Aries Ltd., a wholly owned subsidiary of Cosmo Pharmaceuticals N.V. For further information on Aries, please visit the company's website: www.aries-pharma.com
News Article | November 3, 2016
FAIRPORT, NY, November 03, 2016-- William Y. Chey, MD, DSc, has been included in Marquis Who's Who. As in all Marquis Who's Who biographical volumes, individuals profiled are selected on the basis of current reference value. Factors such as position, noteworthy accomplishments, visibility, and prominence in a field are all taken into account during the selection process.With more than 50 years of experience as a physician, educator and research scientist in gastrointestinal medicine, Dr. Chey is widely recognized for his expertise in the field of gastroenterology and hepatology. Prior to his retirement in 2000, he served as a professor of medicine and director of the Division of Gastroenterology and Hepatology at the University of Rochester Medical Center, and as a consultant gastroenterologist at Canandaigua VA Medical Center. He is a fellow of the American College of Gastroenterology and the American Gastroenterological Association, a member of the AGA Legacy Society, and was a member of the American Association for the Advancement of Science and American Physiological Society, among other medical organizations. In addition, he is the former president of the American Pancreatic Association and the American Society of Acupuncture. He was invited nationally and internationally as a visiting professor by numerous prestigious institutions in the United States, Europe, Asia and Mid-Eastern countries. In particular, he holds the titles of Honorary Professor at the Catholic University College of Medicine, Seoul, Korea and Visiting Professor at Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China and Korea University College of Medicine, Seoul, Korea.After completing his medical education in 1953 through the two top medical schools in Seoul, Korea, Seoul National University and Yonsei University in Seoul, Korea, and serving as a medical officer of the Republic of Korea in the Korean War, Dr. Chey emigrated to the United States in 1954 and had his post-graduate training including internship and residency in internal medicine at City Hospital of New York, fellowship in pathology at Mount Sinai Hospital, New York, and fellowship in hepatology at Jersey City Medical Center, Seton Hall University School of Medicine and Dentistry, Jersey City, NJ. Then he received advanced degrees of Master of Science in Gastroenterology in 1962 and Doctor of Science in Medicine in 1966 from the University of Pennsylvania School of Medicine. At Temple University Medical Center and the Samuel S. Fel's Research Institute, Temple University School of Medicine, Philadelphia, PA, he finished a fellowship in gastroenterology and became a faculty member in 1963. He was an Associate Professor of Medicine and Head of Gastrointestinal Research in 1971 when he was recruited by the University of Rochester School of Medicine and Dentistry, Rochester, NY. He was the Founding Director of the Isaac Gordon Center for Digestive Diseases and Nutrition at the Genesee Hospital and Attending Physician at Strong Memorial Hospital, Rochester, NY. In 1992, he became Director of the Division of Gastroenterology and Hepatology at the University of Rochester Medical Center. He was also the Founding Director of the William and Sheila Konar Center for Digestive and Liver Diseases at Strong Memorial Hospital until his retirement in 2000. During his tenure, he trained numerous clinical and research fellows from the United States and abroad, including Asia, Europe, South America, Mid-East and Africa. The majority of them returned to their native countries and are active in their leadership positions. During the following ten years, he enjoyed practicing gastrointestinal medicine at the Rochester Institute for Digestive Diseases and Sciences and was also actively involved in the American Gastroenterological Association and the American Pancreatic Association. He has been married to Fan K. Tang since 1959. They have 4 children; William D. married to Janine Zwiren, Donna married to Dale Hoellrich, Richard married to Maura Bauman, and Laura married to Richard Warren, and 9 grandchildren; Cameron, Brandon (deceased), Samuel, Megen, Russell, Paris, Wyatt, Josephine and LiLi.He contributed numerous articles to competitive scientific journals, and published many chapters in text-books and two books of his specialty and research. He was a member of the editorial board of the Pancreas and American Journal of Physiology, and has been the Editor-In-Chief of Clinical Endoscopy since 2011. He served as an active member of the National Institute of Health, Surgery and Bioengineering Study Section and a consultant to the Gastrointestinal Drug Advisory Committee, Food and Drug Administration, Department of Health and Human Services.In recognition of his contributions to medicine, Dr. Chey received a wide variety of honors and awards. He was the recipient of the V.L. William and Frisca Go Award for Life Time Achievement from the American Pancreatic Association, the Governor's Award for Excellence in Clinical Research from the American College of Gastroenterology, Distinguished Clinician Award and Mentor's Research Scholar Award from the American Gastroenterological Association, Distinguished Service Award from the Rochester Academy of Medicine and American Top Physicians Award in 2008 from the Consumers' Research Council of America. He has been cited in Marquis Who's Who in America, in Medicine and Health Care, in Science and Engineering, and in the World.About Marquis Who's Who :Since 1899, when A. N. Marquis printed the First Edition of Who's Who in America , Marquis Who's Who has chronicled the lives of the most accomplished individuals and innovators from every significant field of endeavor, including politics, business, medicine, law, education, art, religion and entertainment. Today, Who's Who in America remains an essential biographical source for thousands of researchers, journalists, librarians and executive search firms around the world. Marquis now publishes many Who's Who titles, including Who's Who in America , Who's Who in the World , Who's Who in American Law , Who's Who in Medicine and Healthcare , Who's Who in Science and Engineering , and Who's Who in Asia . Marquis publications may be visited at the official Marquis Who's Who website at www.marquiswhoswho.com
Dimidi E.,King's College London |
Dimidi E.,Center for Digestive Diseases |
Christodoulides S.,King's College London |
Christodoulides S.,Center for Digestive Diseases |
And 3 more authors.
American Journal of Clinical Nutrition | Year: 2014
Background: Functional constipation is a prevalent, burdensome gastrointestinal disorder whose treatment remains challenging. Probiotics have been increasingly investigated in its management.Objective: The aim was to investigate the effect of probiotics on gut transit time, stool output, and constipation symptoms in adults with functional constipation via a systematic review and meta-analysis of randomized controlled trials (RCTs).Design: Studies were identified by searching 4 electronic databases, back-searching reference lists, contacting authors, and hand-searching abstracts. RCTs that reported administration of probiotics in adults with functional constipation were included. Two reviewers independently performed the screening, data extraction, and bias assessment. Outcome data were synthesized by using weighted mean differences (WMDs) or standardized mean differences (SMDs) with the use of a random-effects model.Results: A total of 660 records were identified of which 14 were eligible (1182 patients). Overall, probiotics significantly reduced whole gut transit time by 12.4 h (95% CI: -22.3, -2.5 h) and increased stool frequency by 1.3 bowel movements/wk (95% CI: 0.7, 1.9 bowel movements/wk), and this was significant for Bifidobacterium lactis (WMD: 1.5 bowel movements/wk; 95% CI: 0.7, 2.3 bowel movements/wk) but not for Lactobacillus casei Shirota (WMD: -0.2 bowel movements/wk; 95% CI: -0.8, 0.9 bowel movements/ wk). Probiotics improved stool consistency (SMD: +0.55; 95% CI: 0.27, 0.82), and this was significant for B. lactis (SMD: +0.46; 95% CI: 0.08, 0.85) but not for L. casei Shirota (SMD: +0.26; 95% CI: -0.30, 0.82). No serious adverse events were reported. Attrition and reporting bias were high, whereas selection bias was unclear due to inadequate reporting.Conclusions: Probiotics may improve whole gut transit time, stool frequency, and stool consistency, with subgroup analysis indicating beneficial effects of B. lactis in particular. However, caution is needed with the interpretation of these data due to their high heterogeneity and risk of bias. Adequately powered RCTs are required to better determine the species or strains, doses, and duration of use of probiotics that are most efficacious. © 2014 American Society for Nutrition.
Smits L.P.,University of Amsterdam |
Bouter K.E.C.,University of Amsterdam |
De Vos W.M.,Wageningen University |
De Vos W.M.,University of Helsinki |
And 2 more authors.
Gastroenterology | Year: 2013
There has been growing interest in the use of fecal microbiota for the treatment of patients with chronic gastrointestinal infections and inflammatory bowel diseases. Lately, there has also been interest in its therapeutic potential for cardiometabolic, autoimmune, and other extraintestinal conditions that were not previously considered to be associated with the intestinal microbiota. Although it is not clear if changes in the microbiota cause these conditions, we review the most current and best methods for performing fecal microbiota transplantation and summarize clinical observations that have implicated the intestinal microbiota in various diseases. We also discuss case reports of fecal microbiota transplantations for different disorders, including Clostridium difficile infection, irritable bowel syndrome, inflammatory bowel diseases, insulin resistance, multiple sclerosis, and idiopathic thrombocytopenic purpura. There has been increasing focus on the interaction between the intestinal microbiome, obesity, and cardiometabolic diseases, and we explore these relationships and the potential roles of different microbial strains. We might someday be able to mine for intestinal bacterial strains that can be used in the diagnosis or treatment of these diseases. © 2013 by the AGA Institute.
Wright N.A.,Center for Digestive Diseases |
Wright N.A.,Cancer Research UK Research Institute |
Poulsom R.,Cancer Research UK Research Institute
Journal of Pathology | Year: 2012
This 2012 Annual Review Issue of The Journal of Pathology argues strongly that cell biology, in its many disciplines, underpins the foundation of our understanding of the mechanisms of disease-the holy grail of pathology. Our increasing knowledge of the human genome will not be enough to attain this goal without parallel developments in our comprehension of the results, at the cellular level, of these genetic changes. In the end, it is cell biology and cell biologists who will deliver this mission. Copyright © 2011 Pathological Society of Great Britain and Ireland. Published by John Wiley & Sons, Ltd.
Borody T.J.,Center for Digestive Diseases |
Paramsothy S.,St Vincents Hospital Clinical School |
Agrawal G.,Center for Digestive Diseases
Current Gastroenterology Reports | Year: 2013
Fecal microbiota transplantation (FMT) has attracted great interest in recent years, largely due to the global Clostridium difficile infection (CDI) epidemic and major advances in metagenomic sequencing of the gastrointestinal (GI) microbiota, with growing understanding of its structure and function. FMT is now recommended as the most effective therapy for relapsing CDI and, with further refinement, may even be used in "first-time" CDI. There is interest also in other conditions related to GI dysbiosis-for example, inflammatory bowel disease, irritable bowel syndrome, obesity, and diabetes mellitus-although quality evidence is at present lacking. A few trials are now underway in FMT for ulcerative colitis. Many unanswered questions remain, including FMT methodology-for example, optimal route of administration, what makes a "good donor," safety issues, and long-term effects of FMT. © 2013 Springer Science+Business Media New York.
Borody T.J.,Center for Digestive Diseases |
Campbell J.,Center for Digestive Diseases
Gastroenterology Clinics of North America | Year: 2012
Fecal microbiota transplantation (FMT) has gained widespread recognition in light of the recent Clostridium difficile infection (CDI) epidemic, responsible for almost 110,000 deaths per year. The procedure's success rate has caused experts to reflect on what other conditions may benefit. This article provides an overview of (1) description and history of FMT, (2) FMT publications in CDI, (3) the concept of the gut microbiota as a virtual organ, (4) rationale for FMT use, (5) FMT use in inflammatory bowel disease, (6) emerging FMT applications, (7) how FMT is currently performed, and (8) how FMT may be performed in the future. © 2012 Elsevier Inc.
Ford A.C.,Center for Digestive Diseases |
Axon A.T.R.,Center for Digestive Diseases
Helicobacter | Year: 2010
This article summarizes the published literature concerning the epidemiology and public health implications of Helicobacter pylori infection published from April 2009 through March 2010. Prevalence of infection varied between 7 and 87% and was lower in European studies. All retrieved studies examining transmission of infection concluded that spread is from person-to-person. One study collecting stool and vomitus samples from patients with acute gastroenteritis detected H. pylori DNA in 88% of vomitus and 74% of stool samples. Proposed risk factors for infection included male gender, increasing age, shorter height, tobacco use, lower socioeconomic status, obesity, and lower educational status of the parents in studies conducted among children. Decision analysis models suggest preventing acquisition of H. pylori, via vaccination in childhood, could be cost-effective and may reduce incidence of gastric cancer by over 40%. As yet, no country has adopted public health measures to treat infected individuals or prevent infection in populations at risk. © 2010 Blackwell Publishing Ltd.
Miehlke S.,Center for Digestive Diseases
Digestive Diseases | Year: 2014
Eosinophilic esophagitis (EoE) may affect individuals at any age with a predominance for Caucasian males. The clinical manifestation of EoE is strongly age dependent. While dysphagia and food impaction are typical lead symptoms in adults and adolescents, infants often present with unspecific symptoms such as feeding problems, abdominal pain and vomiting. Some EoE patients may also experience heartburn. Therefore, EoE should always be considered in cases of heartburn refractory to antireflux therapy. Concomitant allergic diseases such as asthma, rhinitis and eczema are prevalent. Peripheral eosinophilia and elevated total serum IgE values are found in up to 50 and 70% of cases, respectively. Endoscopic features of EoE are variable and none of them is pathognomonic. Frequent findings are mucosal edema, furrows, exudates and corrugated rings. These endoscopic abnormalities have high specificities (90-95%), but low sensitivities (15-48%). A novel grading and classification system for the endoscopic assessment of EoE has been proposed which includes fixed rings, exudates, furrows and edema as major features. This classification system demonstrated good interobserver agreement among pediatric and adult gastroenterologists, and presents a useful tool to standardize endoscopic assessments and to further investigate the relation between endoscopic manifestation, clinical activity and response to treatment in EoE. Long-term follow-up studies have shown that EoE is a chronic disease causing recurrent dysphagia in the majority of cases. The prevalence of strictures significantly increases with the duration of disease, which stresses the importance of early diagnosis and consequent treatment of EoE. © 2014 S. Karger AG, Basel.
Schroeder B.,Center for Digestive Diseases |
Schulze R.J.,Center for Digestive Diseases |
Weller S.G.,Center for Digestive Diseases |
Sletten A.C.,Center for Digestive Diseases |
And 2 more authors.
Hepatology | Year: 2015
Autophagy is a central mechanism by which hepatocytes catabolize lipid droplets (LDs). Currently, the regulatory mechanisms that control this important process are poorly defined. The small guanosine triphosphatase (GTPase) Rab7 has been implicated in the late endocytic pathway and is known to associate with LDs, although its role in LD breakdown has not been tested. In this study, we demonstrate that Rab7 is indispensable for LD breakdown ("lipophagy") in hepatocytes subjected to nutrient deprivation. Importantly, Rab7 is dramatically activated in cells placed under nutrient stress; this activation is required for the trafficking of both multivesicular bodies and lysosomes to the LD surface during lipophagy, resulting in the formation of a lipophagic "synapse." Depletion of Rab7 leads to gross morphological changes of multivesicular bodies, lysosomes, and autophagosomes, consequently leading to attenuation of hepatocellular lipophagy. Conclusion: These findings provide additional support for the role of autophagy in hepatocellular LD catabolism while implicating the small GTPase Rab7 as a key regulatory component of this essential process. © 2015 by the American Association for the Study of Liver Diseases.