New Directions for Biologic Targets in Urothelial Carcinoma
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Research in Your Backyard Developing Cures, Creating Jobs
Research in Your Backyard Developing Cures, Creating Jobs PHARMACEUTICAL CLINICAL TRIALS IN ILLINOIS Dots show locations of clinical trials in the state. Executive Summary This report shows that biopharmaceutical research com- Quite often, biopharmaceutical companies hire local panies continue to be vitally important to the economy research institutions to conduct the tests and in Illinois, and patient health in Illinois, despite the recession. they help to bolster local economies in communities all over the state, including Chicago, Decatur, Joliet, Peoria, At a time when the state still faces significant economic Quincy, Rock Island, Rockford and Springfield. challenges, biopharmaceutical research companies are conducting or have conducted more than 4,300 clinical For patients, the trials offer another potential therapeutic trials of new medicines in collaboration with the state’s option. Clinical tests may provide a new avenue of care for clinical research centers, university medical schools and some chronic disease sufferers who are still searching for hospitals. Of the more than 4,300 clinical trials, 2,334 the medicines that are best for them. More than 470 of the target or have targeted the nation’s six most debilitating trials underway in Illinois are still recruiting patients. chronic diseases—asthma, cancer, diabetes, heart dis- ease, mental illnesses and stroke. Participants in clinical trials can: What are Clinical Trials? • Play an active role in their health care. • Gain access to new research treatments before they In the development of new medicines, clinical trials are are widely available. conducted to prove therapeutic safety and effectiveness and compile the evidence needed for the Food and Drug • Obtain expert medical care at leading health care Administration to approve treatments. -
Tanibirumab (CUI C3490677) Add to Cart
5/17/2018 NCI Metathesaurus Contains Exact Match Begins With Name Code Property Relationship Source ALL Advanced Search NCIm Version: 201706 Version 2.8 (using LexEVS 6.5) Home | NCIt Hierarchy | Sources | Help Suggest changes to this concept Tanibirumab (CUI C3490677) Add to Cart Table of Contents Terms & Properties Synonym Details Relationships By Source Terms & Properties Concept Unique Identifier (CUI): C3490677 NCI Thesaurus Code: C102877 (see NCI Thesaurus info) Semantic Type: Immunologic Factor Semantic Type: Amino Acid, Peptide, or Protein Semantic Type: Pharmacologic Substance NCIt Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor tyrosine kinase expressed by endothelial cells, while VEGF is overexpressed in many tumors and is correlated to tumor progression. PDQ Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor -
Chemotherapy for Metastatic Breast Cancer (MBC)
Clinical Conversations Between an Oncology Nurse and Oncology Pharmacist During the Treatment of Patients With Breast Cancer: A Focus on Oral Chemotherapeutic Formulations © 2020. All rights reserved. No part of this report may be reproduced or distributed without the expressed written permission of PTCE. Faculty Information Chair Danielle Roman, PharmD, BCOP Manager, Clinical Pharmacy Services Allegheny Health Network Pittsburgh, Pennsylvania Allison Butts, PharmD, BCOP Kandra Horne, DNP, APRN, WHNP-BC Clinical Coordinator, Oncology Pharmacy Women’s Health Care Nurse Practitioner UK HealthCare Breast and GYN Oncology: Medical Oncology Assistant Adjunct Professor Winship Cancer Institute: Emory Healthcare UK College of Pharmacy Atlanta, Georgia Lexington, Kentucky This activity is supported by an educational grant from Athenex. Educational Objectives At the completion of this activity, participants will be able to: • Distinguish optimized treatment approaches for breast cancer based on disease- and patient-specific factors and potential places in therapy for oral formulations • Analyze the results of recent clinical trials with recently approved and emerging treatment options to inform the appropriate management of adverse effects and adherence for patients with breast cancer • Examine the benefits of multidisciplinary care across multiple practice environments for patients with breast cancer to optimize patient outcomes Evolving Oral Chemotherapeutic Opportunities in Breast Cancer Care Danielle Roman, PharmD, BCOP Manager, Clinical Pharmacy -
Modifications to the Harmonized Tariff Schedule of the United States To
U.S. International Trade Commission COMMISSIONERS Shara L. Aranoff, Chairman Daniel R. Pearson, Vice Chairman Deanna Tanner Okun Charlotte R. Lane Irving A. Williamson Dean A. Pinkert Address all communications to Secretary to the Commission United States International Trade Commission Washington, DC 20436 U.S. International Trade Commission Washington, DC 20436 www.usitc.gov Modifications to the Harmonized Tariff Schedule of the United States to Implement the Dominican Republic- Central America-United States Free Trade Agreement With Respect to Costa Rica Publication 4038 December 2008 (This page is intentionally blank) Pursuant to the letter of request from the United States Trade Representative of December 18, 2008, set forth in the Appendix hereto, and pursuant to section 1207(a) of the Omnibus Trade and Competitiveness Act, the Commission is publishing the following modifications to the Harmonized Tariff Schedule of the United States (HTS) to implement the Dominican Republic- Central America-United States Free Trade Agreement, as approved in the Dominican Republic-Central America- United States Free Trade Agreement Implementation Act, with respect to Costa Rica. (This page is intentionally blank) Annex I Effective with respect to goods that are entered, or withdrawn from warehouse for consumption, on or after January 1, 2009, the Harmonized Tariff Schedule of the United States (HTS) is modified as provided herein, with bracketed matter included to assist in the understanding of proclaimed modifications. The following supersedes matter now in the HTS. (1). General note 4 is modified as follows: (a). by deleting from subdivision (a) the following country from the enumeration of independent beneficiary developing countries: Costa Rica (b). -
Horizon Scanning Status Report, Volume 2
PCORI Health Care Horizon Scanning System Volume 2, Issue 3 Horizon Scanning Status Report September 2020 Prepared for: Patient-Centered Outcomes Research Institute 1828 L St., NW, Suite 900 Washington, DC 20036 Contract No. MSA-HORIZSCAN-ECRI-ENG-2018.7.12 Prepared by: ECRI Institute 5200 Butler Pike Plymouth Meeting, PA 19462 Investigators: Randy Hulshizer, MA, MS Damian Carlson, MS Christian Cuevas, PhD Andrea Druga, PA-C Marcus Lynch, PhD, MBA Misha Mehta, MS Prital Patel, MPH Brian Wilkinson, MA Donna Beales, MLIS Jennifer De Lurio, MS Eloise DeHaan, BS Eileen Erinoff, MSLIS Cassia Hulshizer, AS Madison Kimball, MS Maria Middleton, MPH Diane Robertson, BA Melinda Rossi, BA Kelley Tipton, MPH Rosemary Walker, MLIS Andrew Furman, MD, MMM, FACEP Statement of Funding and Purpose This report incorporates data collected during implementation of the Patient-Centered Outcomes Research Institute (PCORI) Health Care Horizon Scanning System, operated by ECRI under contract to PCORI, Washington, DC (Contract No. MSA-HORIZSCAN-ECRI-ENG-2018.7.12). The findings and conclusions in this document are those of the authors, who are responsible for its content. No statement in this report should be construed as an official position of PCORI. An intervention that potentially meets inclusion criteria might not appear in this report simply because the Horizon Scanning System has not yet detected it or it does not yet meet inclusion criteria outlined in the PCORI Health Care Horizon Scanning System: Horizon Scanning Protocol and Operations Manual. Inclusion or absence of interventions in the horizon scanning reports will change over time as new information is collected; therefore, inclusion or absence should not be construed as either an endorsement or rejection of specific interventions. -
Development of a Four-Step Semi-Biosynthesis of the Anticancer Drug Paclitaxel and Its Analogues
DEVELOPMENT OF A FOUR-STEP SEMI-BIOSYNTHESIS OF THE ANTICANCER DRUG PACLITAXEL AND ITS ANALOGUES By Chelsea Thornburg A DISSERTATION Submitted to Michigan State University in partial fulfillment of the requirements for the degree of Biochemistry and Molecular Biology ‒ Doctor of Philosophy 2015 ABSTRACT DEVELOPMENT OF A FOUR-STEP SEMI-BIOSYNTHESIS OF THE ANTICANCER DRUG PACLITAXEL AND ITS ANALOGUES By Chelsea Thornburg Paclitaxel (Taxol®) is a widely used chemotherapeutic drug with additional medical applications in drug-eluting stents as an anti-restenosis treatment. Paclitaxel is a structurally complex natural product with an excellent scaffold for designing analogs with pharmacological properties. To date, clinically approved analogs include docetaxel and cabazitaxel for the treatment of additional cancers. Currently, plant cell fermentation methods produce paclitaxel and large quantities of the precursors 10-deacetylbaccatin III (10-DAB) and baccatin III. The complexity of the semi-characterized ~19-step paclitaxel biosynthetic pathway limits bioengineering attempts. However, the availability of 10-DAB and baccatin III suggests a semi-biosynthetic pathway to paclitaxel starting with these precursors is feasible. We have designed a short, simple biosynthetic pathway, capable of making paclitaxel, analogs, and/or valuable precursors for the semi-synthesis of additional analogs of biological interest. The paclitaxel biosynthesis enzyme baccatin III: 3-amino-13-O-phenylpropanoyl CoA transferase (BAPT) and the bacterial (2R,3S)-phenylisoserinyl CoA ligase (PheAT) produce N-debenzoylpaclitaxel, N-debenzoyldocetaxel, or precursor analogs. The addition of the paclitaxel biosynthetic N-debenzoyltaxol-N-benzoyltransferase (NDTNBT) and the bacterial benzoate CoA ligase (BadA) produce paclitaxel or other N-acylated analogs. In this dissertation, BAPT and BadA are kinetically characterized. -
I Regulations
23.2.2007 EN Official Journal of the European Union L 56/1 I (Acts adopted under the EC Treaty/Euratom Treaty whose publication is obligatory) REGULATIONS COUNCIL REGULATION (EC) No 129/2007 of 12 February 2007 providing for duty-free treatment for specified pharmaceutical active ingredients bearing an ‘international non-proprietary name’ (INN) from the World Health Organisation and specified products used for the manufacture of finished pharmaceuticals and amending Annex I to Regulation (EEC) No 2658/87 THE COUNCIL OF THE EUROPEAN UNION, (4) In the course of three such reviews it was concluded that a certain number of additional INNs and intermediates used for production and manufacture of finished pharmaceu- ticals should be granted duty-free treatment, that certain of Having regard to the Treaty establishing the European Commu- these intermediates should be transferred to the list of INNs, nity, and in particular Article 133 thereof, and that the list of specified prefixes and suffixes for salts, esters or hydrates of INNs should be expanded. Having regard to the proposal from the Commission, (5) Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (1) established the Combined Nomenclature Whereas: (CN) and set out the conventional duty rates of the Common Customs Tariff. (1) In the course of the Uruguay Round negotiations, the Community and a number of countries agreed that duty- (6) Regulation (EEC) No 2658/87 should therefore be amended free treatment should be granted to pharmaceutical accordingly, products falling within the Harmonised System (HS) Chapter 30 and HS headings 2936, 2937, 2939 and 2941 as well as to designated pharmaceutical active HAS ADOPTED THIS REGULATION: ingredients bearing an ‘international non-proprietary name’ (INN) from the World Health Organisation, specified salts, esters or hydrates of such INNs, and designated inter- Article 1 mediates used for the production and manufacture of finished products. -
Supportive Oncology
Utku_v1_A4_book_01_2011 14/12/2011 15:10 Page 228 Supportive Oncology The End of Cytotoxics? Nalân Utku Private Lecturer, Institute for Medical Immunology, Charité University Hospital Berlin Abstract Cytotoxic drugs were the first form of cancer chemotherapy to be established, but they can have quite severe side effects. Cytotoxics attack all rapidly dividing cells, including healthy cells and cancer cells. They can therefore cause side effects such as loss of hair, damage to the skin and mucosa, and damage to bone marrow, affecting the immune system. For this reason, the focus of some cancer research has moved from cytotoxics to targeted therapeutics, including monoclonal antibodies. Monoclonal antibodies can be very effective in patients who express the appropriate target; however, not all patients do, and some develop resistance. Monoclonal antibodies, like other biologicals, are also very costly. All is not lost for cytotoxics. Because they have been around for so long, there is an abundance of data on their modes of action. Based on these data, researchers have developed newer cytotoxics that are more effective and have fewer side effects, and approaches that deliver cytotoxics more safely or target them to tumours. Keywords Antigens, cancer, cytotoxics, drug delivery, monoclonal antibodies, targeting Disclosure: Nalân Utku is Managing Director of CellAct Pharma GmbH, a biotech company focused on the development of innovative therapeutics. Received: 5 May 2011 Accepted: 6 September 2011 Citation: European Oncology & Haematology, 2011;7(4):228–33 DOI: 10.17925/EOH.2011.07.04.228 Correspondence: Nalân Utku, Institut für Medizinische Immunologie, Charité Universitätsmedizin Berlin, Campus Virchow-Clinikum, Augustenburger Platz 1, 13353 Berlin, Germany. -
Ep 3067054 A1
(19) TZZ¥ZZ_T (11) EP 3 067 054 A1 (12) EUROPEAN PATENT APPLICATION (43) Date of publication: (51) Int Cl.: 14.09.2016 Bulletin 2016/37 A61K 31/505 (2006.01) A61K 31/55 (2006.01) A61K 38/17 (2006.01) A61P 35/00 (2006.01) (21) Application number: 16156278.0 (22) Date of filing: 10.09.2008 (84) Designated Contracting States: • MIKULE, Keith AT BE BG CH CY CZ DE DK EE ES FI FR GB GR Cambridge, MA Massachusetts 02139 (US) HR HU IE IS IT LI LT LU LV MC MT NL NO PL PT • LI, Youzhi RO SE SI SK TR Westwood, MA 02090 (US) (30) Priority: 10.09.2007 US 971144 P (74) Representative: Finnie, Isobel Lara 13.12.2007 US 13372 Haseltine Lake LLP Lincoln House, 5th Floor (62) Document number(s) of the earlier application(s) in 300 High Holborn accordance with Art. 76 EPC: London WC1V 7JH (GB) 08830633.7 / 2 200 431 Remarks: (71) Applicant: Boston Biomedical, Inc. This application was filed on 18-02-2016 as a Cambridge, MA 02139 (US) divisional application to the application mentioned under INID code 62. (72) Inventors: • LI, Chiang, Jia Cambridge, MA Massachusetts 02141 (US) (54) NOVEL COMPOSITIONS AND METHODS FOR CANCER TREATMENT (57) The present invention relates to the composition and methods of use of Stat3 pathway inhibitors or cancer stem cell inhibitors in combination treatment of cancer. EP 3 067 054 A1 Printed by Jouve, 75001 PARIS (FR) EP 3 067 054 A1 Description REFERENCE TO RELATED APPLICATIONS 5 [0001] This application claims priority to and the benefit of U.S. -
Update Breast Cancer 2021 Part 2
Published online: 2021-05-03 GebFra Science | Review Update Breast Cancer 2021 Part 2 – Advanced Stages, Long-Term Consequences and Biomarkers Update Mammakarzinom 2021 Teil 2 – fortgeschrittene Stadien, Langzeitfolgen und Biomarker Authors Nina Ditsch1, Elmar Stickeler 2, Annika Behrens 3,ErikBelleville4, Peter A. Fasching 3, Tanja N. Fehm 5,AndreasD.Hart- kopf 6, Christian Jackisch 7,WolfgangJanni8, Cornelia Kolberg-Liedtke 9,Hans‑Christian Kolberg 10, Diana Lüftner 11, Michael P. Lux12, Volkmar Müller 13, Andreas Schneeweiss 14, Florian Schütz 15, Carla E. Schulmeyer 3, Hans Tesch16, Christoph Thomssen 17,ChristophUleer18, Michael Untch 19, Manfred Welslau 20, Achim Wöckel 21,LenaA.Wurmthaler3, Rachel Würstlein 22,MarcThill23, Bahriye Aktas 24 Affiliations 1 Department of Gynecology and Obstetrics, University 16 Oncology Practice at Bethanien Hospital Frankfurt, Hospital Augsburg, Augsburg, Germany Frankfurt, Germany 2 Department of Gynecology and Obstetrics, RWTH 17 Department of Gynaecology, Martin-Luther-University University Hospital Aachen, Aachen, Germany Halle-Wittenberg, Halle (Saale), Germany 3 Erlangen University Hospital, Department of Gynecology 18 Praxisgemeinschaft Frauenärzte am Bahnhofsplatz, and Obstetrics, Comprehensive Cancer Center Erlangen- Hildesheim, Germany EMN, Friedrich-Alexander University Erlangen-Nuremberg, 19 Clinic for Gynecology and Obstetrics, Breast Cancer Erlangen, Germany Center, Genecologic Oncology Center, Helios Klinikum 4 ClinSol GmbH & Co. KG, Würzburg, Germany Berlin Buch, Berlin, Germany 5 -
Analytics for Improved Cancer Screening and Treatment John
Analytics for Improved Cancer Screening and Treatment by John Silberholz B.S. Mathematics and B.S. Computer Science, University of Maryland (2010) Submitted to the Sloan School of Management in partial fulfillment of the requirements for the degree of Doctor of Philosophy in Operations Research at the MASSACHUSETTS INSTITUTE OF TECHNOLOGY September 2015 ○c Massachusetts Institute of Technology 2015. All rights reserved. Author................................................................ Sloan School of Management August 10, 2015 Certified by. Dimitris Bertsimas Boeing Leaders for Global Operations Professor Co-Director, Operations Research Center Thesis Supervisor Accepted by . Patrick Jaillet Dugald C. Jackson Professor Department of Electrical Engineering and Computer Science Co-Director, Operations Research Center 2 Analytics for Improved Cancer Screening and Treatment by John Silberholz Submitted to the Sloan School of Management on August 10, 2015, in partial fulfillment of the requirements for the degree of Doctor of Philosophy in Operations Research Abstract Cancer is a leading cause of death both in the United States and worldwide. In this thesis we use machine learning and optimization to identify effective treatments for advanced cancers and to identify effective screening strategies for detecting early-stage disease. In Part I, we propose a methodology for designing combination drug therapies for advanced cancer, evaluating our approach using advanced gastric cancer. First, we build a database of 414 clinical trials testing chemotherapy regimens for this cancer, extracting information about patient demographics, study characteristics, chemother- apy regimens tested, and outcomes. We use this database to build statistical models to predict trial efficacy and toxicity outcomes. We propose models that use machine learning and optimization to suggest regimens to be tested in Phase II and III clinical trials, evaluating our suggestions with both simulated outcomes and the outcomes of clinical trials testing similar regimens. -
Contessa) (Contessa)
Find Studies About Studies Submit Studies Resources About Site Trial record 1 of 1 for: NCT03326674 Previous Study | Return to List | Next Study Tesetaxel Plus Reduced Dose of Capecitabine vs. Capecitabine in HER2 Negative, HR Positive, MBC (CONTESSA) (CONTESSA) ClinicalTrials.gov Identifier: The safety and scientific validity of this study NCT03326674 is the responsibility of the study sponsor and Recruitment Status : Recruiting investigators. Listing a study does not mean First Posted : October 31, 2017 it has been evaluated by the U.S. Federal Last Update Posted : November 2, Government. Know the risks and potential 2018 benefits of clinical studies and talk to your health care provider before participating. See Contacts and Locations Read our disclaimer for details. Sponsor: Odonate Therapeutics, LLC Information provided by (Responsible Party): Odonate Therapeutics, LLC Study Details Tabular View No Results Posted Disclaimer How to Read a Study Record Study Description Go to Brief Summary: The primary objective is to compare the efficacy of tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone in patients with HER2 negative, HR positive LA/MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. Approximately 600 eligible patients will be randomly assigned in a 1:1 ratio to either Arm A (tesetaxel plus a reduced dose of capecitabine) or Arm B (approved dose of capecitabine alone). Condition or disease Intervention/treatment Phase Breast Cancer Drug: Tesetaxel and Capecitabine Phase 3 Drug: Capecitabine Detailed Description: This is a multinational, multicenter, randomized, open-label, parallel group Phase 3 study. The primary objective is to compare the efficacy of tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone based on PFS, as assessed by an Independent Radiologic Review Committee (IRC), in patients with HER2 negative, HR positive, LA/MBC previously treated with a taxane in the neoadjuvant or adjuvant setting.