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List Item Withdrawal Assessment Report for Folcepri
20 March 2014 EMA/CHMP/219148/2014 Committee for Medicinal Products for Human Use (CHMP) Assessment report Folcepri International non-proprietary name: etarfolatide Procedure No.: EMEA/H/C/002570/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. This AR reflects the CHMP opinion on 20 March 2014, which originally recommended to approve this medicine. The recommendation was conditional to the results of the on-going confirmatory study EC-FV-06. Before the marketing authorisation was granted by the EC, the results of this study became available and did not support the initial recommendation. Subsequently, the company decided to withdraw the application and not to pursue any longer the authorisation for marketing this product. The current report does not include the latest results of this study as the withdrawal of the application did not allow for the CHMP to revise its opinion in light of the new data. For further information please refer to the Q&A which followed the company’s withdrawal of the application. 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5505 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged. Table of contents 1. Background information on the procedure .............................................. 6 1.1. Submission of the dossier ...................................................................................... 6 1.2. Manufacturers ...................................................................................................... 8 1.3. Steps taken for the assessment of the product ......................................................... 8 2. Scientific discussion ............................................................................... -
Potential High-Impact Interventions Report Priority Area 02: Cancer
AHRQ Healthcare Horizon Scanning System – Potential High-Impact Interventions Report Priority Area 02: Cancer Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 540 Gaither Road Rockville, MD 20850 www.ahrq.gov Contract No. HHSA290201000006C Prepared by: ECRI Institute 5200 Butler Pike Plymouth Meeting, PA 19462 December 2012 Statement of Funding and Purpose This report incorporates data collected during implementation of the Agency for Healthcare Research and Quality (AHRQ) Healthcare Horizon Scanning System by ECRI Institute under contract to AHRQ, Rockville, MD (Contract No. HHSA290201000006C). The findings and conclusions in this document are those of the authors, who are responsible for its content, and do not necessarily represent the views of AHRQ. No statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services. This report’s content should not be construed as either endorsements or rejections of specific interventions. As topics are entered into the System, individual topic profiles are developed for technologies and programs that appear to be close to diffusion into practice in the United States. Those reports are sent to various experts with clinical, health systems, health administration, and/or research backgrounds for comment and opinions about potential for impact. The comments and opinions received are then considered and synthesized by ECRI Institute to identify interventions that experts deemed, through the comment process, to have potential for high impact. Please see the methods section for more details about this process. This report is produced twice annually and topics included may change depending on expert comments received on interventions issued for comment during the preceding 6 months. -
Investigator Initiated Study IRB-29839 an Open-Label Pilot Study To
Investigator Initiated Study IRB-29839 An open-label pilot study to evaluate the efficacy and safety of a combination treatment of Sonidegib and BKM120 for the treatment of advanced basal cell carcinomas Version 05 September 2016 NCT02303041 DATE: 12Dec2018 1 Coordinating Center Stanford Cancer Center 875 Blake Wilbur Drive Stanford, CA 94305 And 450 Broadway, MC 5334 Redwood City, CA 94603 Protocol Director and Principal Investigator Anne Lynn S Chang, MD, Director of Dermatological Clinical Trials 450 Broadway St, MC 5334 Redwood City, CA 94603 [email protected] Co-Investigator Anthony Oro, MD PhD 450 Broadway St, MC 5334 Redwood City, CA 94603 [email protected] Biostatistician Shufeng Li, MS 450 Broadway St, MC 5334 Redwood City, CA 94603 [email protected] Study Coordinator Ann Moffat 450 Broadway St, MC 5334 Redwood City, CA 94603 [email protected] 2 Table of Contents 1 Background ................................................................. 7 1.1 Disease Background ..................................................... 7 1.2 Hedgehog Pathway and mechanism of action ............................... 7 1.3 PI3K Pathway and mechanism of action ................................... 9 1.4 Sonidegib Compound Information ............ Error! Bookmark not defined. 1.4.1 Preclinical Studies for Sonidegib ....................................................................11 1.4.2 Muscular system...............................................................................................13 1.4.3 Skeletal system ................................................................................................13 -
PARP1 Trapping by PARP Inhibitors Drives Cytotoxicity Both in Cancer Cells and Healthy Bone Marrow
Author Manuscript Published OnlineFirst on November 14, 2018; DOI: 10.1158/1541-7786.MCR-18-0138 Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. 1 Title: PARP1 trapping by PARP inhibitors drives cytotoxicity both in cancer 2 cells and healthy bone marrow 3 4 Authors: Todd A. Hopkins, William B. Ainsworth, Paul A. Ellis, Cherrie K. 5 Donawho, Enrico L. DiGiammarino, Sanjay C. Panchal, Vivek C. 6 Abraham, Mikkel A. Algire, Yan Shi, Amanda M. Olson, Eric F. Johnson, 7 Julie L. Wilsbacher, David Maag* 8 9 Author affiliations: AbbVie, Inc., North Chicago, Illinois, USA 10 Running title: PARP trapping: impact on in vivo activity of PARP inhibitors 11 Keywords: PARP, DNA damage, veliparib,talazoparib, rucaparib, A-934935 12 Financial support: This work was financially supported by AbbVie, Inc. 13 Corresponding author: *David Maag, Oncology Development, AbbVie, Inc., 1 N. Waukegan 14 Road, North Chicago, Illinois, USA 60064. Phone: 847-937-3969; E- 15 mail: [email protected]. 16 Disclosure: All authors are employees of AbbVie. The design, study conduct, and 17 financial support for this research were provided by AbbVie. AbbVie 18 participated in the interpretation of data, review, and approval of the 19 publication. 20 Word count: 5163/5000 21 Total number of figures and tables: 12 (6 plus 6 supplemental) 22 1 Downloaded from mcr.aacrjournals.org on September 26, 2021. © 2018 American Association for Cancer Research. Author Manuscript Published OnlineFirst on November 14, 2018; DOI: 10.1158/1541-7786.MCR-18-0138 Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. -
ESMO 2014 Scientific Meeting Report
ESMO 2014 Congress Scientific Meeting Report – Lung Cancer Extract 26-30 September 2014 Madrid, Spain Summary The European Society for Medical Oncology (ESMO) Congress, held September 26 to 30 in Madrid, Spain, was a record-breaker on nearly all levels. It was resounding success and in a dedicated infographic you can find the congress statistics. A primary emphasis in the scientific programme was placed on precision medicine and how it will change the future treatment landscape in oncology. In addition, a number of scientific presentations were dedicated to cancer immunology and immunotherapy across multiple tumour types. This report is an overview of key scientific presentations made during the congress by leading international investigators. It attempts to represent the diversity and depth of the ESMO 2014 scientific programme, as well as advances in oncology. Infographic (right): ESMO 2014 record breaking Congress ESMO 2014 Congress Meeting Report Page 1 © Copyright 2014 European Society for Medical Oncology. All rights reserved worldwide. Contents Lung Cancer .................................................................................................................................... 3 Final results of the SAKK 16/00 trial: A randomised phase III trial comparing neoadjuvant chemoradiation to chemotherapy alone in stage IIIA/N2 NSCLC ................................................. 3 Adjuvant treatment with MAGE-A3 cancer immunotherapeutic in patients with resected NSCLC does not increase DFS: Results of the MAGRIT, a double-blind, -
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. -
Signal Transduction Guide
Signal Transduction Product Guide | 2007 NEW! Selective T-type Ca2+ channel blockers, NNC 55-0396 and Mibefradil ZM 447439 – Novel Aurora Kinase Inhibitor NEW! Antibodies for Cancer Research EGFR-Kinase Selective Inhibitors – BIBX 1382 and BIBU 1361 DRIVING RESEARCH FURTHER Calcium Signaling Agents ...................................2 G Protein Reagents ...........................................12 Cell Cycle and Apoptosis Reagents .....................3 Ion Channel Modulators ...................................13 Cyclic Nucleotide Related Tools ...........................7 Lipid Signaling Agents ......................................17 Cytokine Signaling Agents ..................................9 Nitric Oxide Tools .............................................19 Enzyme Inhibitors/Substrates/Activators ..............9 Protein Kinase Reagents....................................22 Glycobiology Agents .........................................12 Protein Phosphatase Reagents ..........................33 Neurochemicals | Signal Transduction Agents | Peptides | Biochemicals Signal Transduction Product Guide Calcium Signaling Agents ......................................................................................................................2 Calcium Binding Protein Modulators ...................................................................................................2 Calcium ATPase Modulators .................................................................................................................2 Calcium Sensitive Protease -
Genomic Oncology: Moving Beyond the Tip of the Iceberg Jane De Lartigue, Phd
FeatureCommunity Report Genomic oncology: moving beyond the tip of the iceberg Jane de Lartigue, PhD istorically, cancer has been diagnosed and in patients with lung cancer, even the most efec- treated on the basis of the tissue of ori- tive targeted therapies can fail if used in the wrong Hgin. Te promise of personalized therapy, patient population.5,6 matched more precisely to an individual’s tumor, In recognition of this issue, the oncology feld has was ushered in with the development of molecularly developed molecular biomarkers that can predict targeted therapies, based on a greater understanding response, or lack thereof, to targeted therapy. Drugs of cancer as a genomic-driven disease. Here, we dis- are now commonly being evaluated in trials that cuss some of the evolution of genomic oncology, the select eligible patients on the basis of biomarker pos- inherent complexities and challenges, and how novel itivity, and a number of companion diagnostics have clinical trial designs are among the strategies being been codeveloped to assist in these eforts (Table 1). developed to address them and shape the future of Notable successes include the development of the personalized medicine in cancer. monoclonal antibody trastuzumab for patients with breast cancers that have human epidermal growth The evolution of genomic oncology factor receptor 2 (HER2) gene amplifcation or In the 15 years since the frst map of the human HER2 protein overexpression,7 and the small mol- genome emerged, genetics has become an inte- ecule BRAF kinase inhibitor -
Identification of Candidate Repurposable Drugs to Combat COVID-19 Using a Signature-Based Approach
www.nature.com/scientificreports OPEN Identifcation of candidate repurposable drugs to combat COVID‑19 using a signature‑based approach Sinead M. O’Donovan1,10, Ali Imami1,10, Hunter Eby1, Nicholas D. Henkel1, Justin Fortune Creeden1, Sophie Asah1, Xiaolu Zhang1, Xiaojun Wu1, Rawan Alnafsah1, R. Travis Taylor2, James Reigle3,4, Alexander Thorman6, Behrouz Shamsaei4, Jarek Meller4,5,6,7,8 & Robert E. McCullumsmith1,9* The COVID‑19 pandemic caused by the novel SARS‑CoV‑2 is more contagious than other coronaviruses and has higher rates of mortality than infuenza. Identifcation of efective therapeutics is a crucial tool to treat those infected with SARS‑CoV‑2 and limit the spread of this novel disease globally. We deployed a bioinformatics workfow to identify candidate drugs for the treatment of COVID‑19. Using an “omics” repository, the Library of Integrated Network‑Based Cellular Signatures (LINCS), we simultaneously probed transcriptomic signatures of putative COVID‑19 drugs and publicly available SARS‑CoV‑2 infected cell lines to identify novel therapeutics. We identifed a shortlist of 20 candidate drugs: 8 are already under trial for the treatment of COVID‑19, the remaining 12 have antiviral properties and 6 have antiviral efcacy against coronaviruses specifcally, in vitro. All candidate drugs are either FDA approved or are under investigation. Our candidate drug fndings are discordant with (i.e., reverse) SARS‑CoV‑2 transcriptome signatures generated in vitro, and a subset are also identifed in transcriptome signatures generated from COVID‑19 patient samples, like the MEK inhibitor selumetinib. Overall, our fndings provide additional support for drugs that are already being explored as therapeutic agents for the treatment of COVID‑19 and identify promising novel targets that are worthy of further investigation. -
Horizon Scanning Status Report June 2019
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 Institute 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. A representative from PCORI served as a contracting officer’s technical representative and provided input during the implementation of the horizon scanning system. PCORI does not directly participate in horizon scanning or assessing leads or topics and did not provide opinions regarding potential impact of interventions. Financial Disclosure Statement None of the individuals compiling this information have any affiliations or financial involvement that conflicts with the material presented in this report. Public Domain Notice This document is in the public domain and may be used and reprinted without special permission. Citation of the source is appreciated. All statements, findings, and conclusions in this publication are solely those of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI) or its Board of Governors. -
Overcoming the Challenges of Oral Oncolytic Therapies with a Specialized Crew
Navigating Safely Through Uncharted Waters: Overcoming the Challenges of Oral Oncolytic Therapies with a Specialized Crew Mitchell E. Hughes, PharmD, BCPS, BCOP Clinical Pharmacy Specialist-Hematology/Oncology The Abramson Cancer Center for Advanced Medicine at Penn Medicine Objectives At the completion of this activity, the participant will be able to: 1. List risks associated with dispensing oral oncolytic agent 2. Recognize potential barriers to implementation of a vigilance program for oral oncolytic agents 3. Discuss strategies to improve safety and communications involved with dispensing oral oncolytic agents 2 Disclosure “I have not received any commercial or financial support for this program” 3 Oral Chemotherapy Definition “Any drug you take by mouth to treat cancer. Oral chemo is not given to you with a needle. It’s a liquid or pill that you swallow.” “Chemo you swallow is as strong as other forms of chemo and works just as well. You take oral chemo at home” “But oral chemo drugs cost a lot” –The American Cancer Society 4 Image available from: https://localtvwiti.files.wordpress.com/2014/03/chemo-pills.jpg?quality=85&strip=all https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/chemotherapy/oral-chemotherapy.html Misconceptions Oral chemotherapy is less toxic than intravenous (IV) chemotherapy Oral chemotherapy requires less monitoring than IV Patients will be able to start therapy the day oral chemotherapy is prescribed Oral chemotherapy does not involve any hazardous precautions 5 Image available -
545 © American Association of Pharmaceutical Scientists 2019 P. V
Index A Although, 524 Aberrant expression, 118 Alzheimer’s disease, 305, 326 Abluminal, 47 American type culture collection (ATCC), 537 Actin, 7 AMH, see Anti-Mullerian hormone (AMH) Actinic keratosis, 342 Aminolevulinic acid, 501 Actinomycetes, 485 Amino-triphenyl dicarboxylate-bridged Zr4+ Activated macrophages, 13 metal-organic framework nanoparticles Activation, 93 (NMOFs), 215 Activation functions (AFs), 89 Amphiregulin (AREG), 240 Active targeting, 467 β-Amyloid fibrils, 305 Adamantane–hyaluronic acid, 420 Anaplastic large cell lymphoma (ALCL), 219 Adamantane polyethylene glycol, 473 Anaplastic lymphoma kinase (ALK), 233 Adaptive immune responses, 328 Ancillary targets, 165 Adaptor proteins, 15 Androgen receptor (AR), 115 Adenocarcinoma, 231 Androgen receptor antagonists, 123 Adenomatous polyposis coli (APC), 188, 191 Androgen response elements (ARE), 116 Adenosine triphosphate (ATP), 243 Androgens, 120 Adherens junction, 179 Ang2 inhibitor (recombinant peptide-Fc- Adsorptive endocytosis, 49 fusion protein), 215 Advanced chemorefractory endometrial Angiogenesis, 53, 490, 529 cancers, 193 Angiogenesis factors, 189 Advanced epithelial ovarian, 131 Angiogenic paracrine factors, 490 Advanced gastric adenocarcinoma, 220 Anilinoquinazoline tyrosine kinase inhibitor, 242 Advanced glycation end products (AGE), 305 Annexin V, 493 Advanced/metastatic NSCLC, 258 Annexin V-FITC/propidium iodide assay, Adverse effects, 400 534–536 A glycoprotein hormone, 121 Antagonists, 287, 393 Agonists, 87 Antiangiogenic activity, 527 AIDS, 280 Antiangiogenic