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PI3K Inhibitors in Cancer: Clinical Implications and Adverse Effects
International Journal of Molecular Sciences Review PI3K Inhibitors in Cancer: Clinical Implications and Adverse Effects Rosalin Mishra , Hima Patel, Samar Alanazi , Mary Kate Kilroy and Joan T. Garrett * Department of Pharmaceutical Sciences, College of Pharmacy, University of Cincinnati, Cincinnati, OH 45267-0514, USA; [email protected] (R.M.); [email protected] (H.P.); [email protected] (S.A.); [email protected] (M.K.K.) * Correspondence: [email protected]; Tel.: +1-513-558-0741; Fax: +1-513-558-4372 Abstract: The phospatidylinositol-3 kinase (PI3K) pathway is a crucial intracellular signaling pathway which is mutated or amplified in a wide variety of cancers including breast, gastric, ovarian, colorectal, prostate, glioblastoma and endometrial cancers. PI3K signaling plays an important role in cancer cell survival, angiogenesis and metastasis, making it a promising therapeutic target. There are several ongoing and completed clinical trials involving PI3K inhibitors (pan, isoform-specific and dual PI3K/mTOR) with the goal to find efficient PI3K inhibitors that could overcome resistance to current therapies. This review focuses on the current landscape of various PI3K inhibitors either as monotherapy or in combination therapies and the treatment outcomes involved in various phases of clinical trials in different cancer types. There is a discussion of the drug-related toxicities, challenges associated with these PI3K inhibitors and the adverse events leading to treatment failure. In addition, novel PI3K drugs that have potential to be translated in the clinic are highlighted. Keywords: cancer; PIK3CA; resistance; PI3K inhibitors Citation: Mishra, R.; Patel, H.; Alanazi, S.; Kilroy, M.K.; Garrett, J.T. -
Toward Personalized Treatment in Waldenström Macroglobulinemia
| INDOLENT LYMPHOMA:HOW UNDERSTANDING DISEASE BIOLOGY IS INFLUENCING CLINICAL DECISION-MAKING | Toward personalized treatment in Waldenstrom¨ macroglobulinemia Jorge J. Castillo and Steven P. Treon Bing Center for Waldenstrom¨ Macroglobulinemia, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA Waldenstrom¨ macroglobulinemia (WM) is a rare lymphoma with 1000 to 1500 new patients diagnosed per year in the United States. Patients with WM can experience prolonged survival times, which seem to have increased in the last decade, but relapse is inevitable. The identification of recurrent mutations in the MYD88 and CXCR4 genes has opened avenues of research to better understand and treat patients with WM. These developments are giving way to per- sonalized treatment approaches for these patients, focusing on increasing depth and duration of response alongside lower toxicity rates. In the present document, we review the diagnostic differential, the clinical manifestations, and the pathological and genomic features of patients with WM. We also discuss the safety and efficacy data of alkylating agents, proteasome inhibitors, monoclonal antibodies, and Bruton tyrosine kinase inhibitors in patients with WM. Finally, we propose a genomically driven algorithm for the treatment of WM. The future of therapies for WM appears bright and hopeful, but we should be mindful of the cost-effectiveness and long-term toxicity of novel agents. Diagnostic considerations Learning Objectives The differential diagnosis of WM includes immunoglobulin M (IgM) • To understand recent advances on the biology of Waldenstrom¨ monoclonal gammopathy of undetermined significance; other macroglobulinemia IgM-secreting lymphomas, especially marginal zone lymphoma (MZL); • To review available and investigational agents for the treat- and the rare IgM multiple myeloma (MM). -
DRUGS REQUIRING PRIOR AUTHORIZATION in the MEDICAL BENEFIT Page 1
Effective Date: 08/01/2021 DRUGS REQUIRING PRIOR AUTHORIZATION IN THE MEDICAL BENEFIT Page 1 Therapeutic Category Drug Class Trade Name Generic Name HCPCS Procedure Code HCPCS Procedure Code Description Anti-infectives Antiretrovirals, HIV CABENUVA cabotegravir-rilpivirine C9077 Injection, cabotegravir and rilpivirine, 2mg/3mg Antithrombotic Agents von Willebrand Factor-Directed Antibody CABLIVI caplacizumab-yhdp C9047 Injection, caplacizumab-yhdp, 1 mg Cardiology Antilipemic EVKEEZA evinacumab-dgnb C9079 Injection, evinacumab-dgnb, 5 mg Cardiology Hemostatic Agent BERINERT c1 esterase J0597 Injection, C1 esterase inhibitor (human), Berinert, 10 units Cardiology Hemostatic Agent CINRYZE c1 esterase J0598 Injection, C1 esterase inhibitor (human), Cinryze, 10 units Cardiology Hemostatic Agent FIRAZYR icatibant J1744 Injection, icatibant, 1 mg Cardiology Hemostatic Agent HAEGARDA c1 esterase J0599 Injection, C1 esterase inhibitor (human), (Haegarda), 10 units Cardiology Hemostatic Agent ICATIBANT (generic) icatibant J1744 Injection, icatibant, 1 mg Cardiology Hemostatic Agent KALBITOR ecallantide J1290 Injection, ecallantide, 1 mg Cardiology Hemostatic Agent RUCONEST c1 esterase J0596 Injection, C1 esterase inhibitor (recombinant), Ruconest, 10 units Injection, lanadelumab-flyo, 1 mg (code may be used for Medicare when drug administered under Cardiology Hemostatic Agent TAKHZYRO lanadelumab-flyo J0593 direct supervision of a physician, not for use when drug is self-administered) Cardiology Pulmonary Arterial Hypertension EPOPROSTENOL (generic) -
Biotechnology Worldwide
Biotechnology Worldwide There are several countries that are making special efforts to both develop and capitalise on Biotechnology. Chief amongst them is America, though cutting edge work is also going on in the UK, Ireland, Germany, Korea, Singapore, China and Japan. • America is the world leader in biotechnology, it has 1,379 biotechnology companies and employs 174,000 people. It spends £9 billion on research into biotechnology. • The European market for goods and services dependent on biotechnology is currently estimated at £30 billion and is forecast to exceed £100 billion by the year 2005 • The UK leads Europe in biotechnology and employs 19,000 people • The UK has 300 dedicated biotechnology companies and a further 250-300 involved in broader bioscience related activities • The industrial sectors which stand to benefit from biotechnology are pharmaceutical, agriculture, food and drink, chemicals and environmental technologies • Germany is the second strongest country in Europe, with 332 companies but fewer products in development than the UK. UK The UK biotechnology industry is regarded as second only to the huge effort taking place in the States. UK biotechnology companies generate over a billion pounds in revenue; half of this is pumped back into research and development. The industry has particular strengths, for example: • Britain was a key player in the world wide project of sequencing the 30,000 genes of the human genome. The announcement of the first working draft of the human genome marks a significant step forward in our understanding of the way in which we understand and develop treatments for incurable genetic conditions. -
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. -
Say on Pay Results (As of September 5)
THIS REPORT CAN BE ACCESSED AT HTTP://WWW.SEMLERBROSSY.COM/SAYONPAY NOTE: THIS WILL BE OUR FINAL SAY ON PAY UPDATE FOR 2012. WE WILL ISSUE A FULL REPORT PROVIDING RESULTS FOR THE ENTIRE 2012 PROXY SEASON IN JANUARY 2013. PLEASE CONTINUE TO VISIT OUR SAY ON PAY BLOG FOR UPDATES. SAY ON PAY RESULTS 2012 RUSSELL 3000 SEPTEMBER 5 2012 SAY ON PAY RESULTS: RUSSELL 3000 SHAREHOLDER VOTING SUMMARY OF FINDINGS 2012 Vote Results (n=2,025) 2 The majority of companies continue to pass Say on Pay in 2012 with substantial shareholder support: — 1,466 companies (72%) passed with over 90% support — 381 companies (19%) passed with between 70% and 90% support — 125 companies (6%) passed with between 50% and 70% support — 53 companies (2.6%) in the Russell 3000 have failed Vote of the Week McKesson received a vote of 62%, a decline of 8% from 2011, amidst criticism from shareholders and 3 their advisors over high relative CEO pay and retirement benefits Vote Results by Industry Health Care companies have received proportionally less support than other industries, while 4 Consumer Staple and Financial companies have received the most support Vote Results and Market Value 5 There does not appear to be a strong correlation between a company’s market value and Say on Pay vote result How Vote Results Changed in 2012 6 Companies below 70% in 2011 have generally received increased vote support in 2012: — 26 of 30 companies that failed in 2011 have passed in 2012 — Companies between 50‐70% in 2011 have improved by an average of 13% in 2012 Vote results for companies -
Comment Letter
July 23, 2008 Subject: Follow-up on July 22 Meeting Dr. Sirri et al.: I thank you for meeting with Ken Salomon, John Welborn and me yesterday afternoon to discuss Reg SHO, naked short selling and the SEC's recent emergency order. As a follow-up, I want to emphasize the following points: 1. OSTK continues to believe that it is critical that the SEC extend the pre-borrow requirement of the emergency order to the entire market, not just the 19 select companies. OSTK requests that the SEC promptly undertake swift rulemaking so that this protection applies fairly across the market. 2. OSTK continues to support the prompt and full elimination of the option market maker exception, an exception that swallows up the good intentions of Reg SHO. During yesterday's meeting, we discussed the relationship between the markets for equities and their corresponding derivatives (including listed options). You stated that options market makers enjoy an exception from the Reg SHO requirement that they locate and/or deliver shares when hedging against options positions. I am not sure that I would read Reg SHO to say that. However, under your theory, if an options market maker sells a put with a 6- month expiration, then that same market maker has the legal right to naked short and fail to deliver an equivalent amount of the underlying equity (leaving the option market maker "delta neutral”) for six months. This exception is unnecessary and open to abuse/manipulation, particularly with the married puts that often occur in Reg SHO threshold securities. -
Current Sustaining Member Companies
CURRENT SUSTAINING MEMBER COMPANIES MEMBER FOR OVER: 10 Years 25 Years 50 Years Member Since (alphabetical order) 1976 3M Medical Markets Center 2010 Endo Pharmaceuticals 1963 Novartis Pharmaceuticals 2019 10-Square Solutions 2019 EMD Serono, Inc. 2019 Novo Nordisk, Inc. 1985 Abbott Laboratories, Inc. 2017 Exelixis 2019 Optinose 2013 AbbVie Inc. 2016 Express Scripts Federal Pharmacy 2018 Organogenesis 2017 ACADIA Pharmaceuticals, Inc. 2010 Federal Practitioner 2004 Otsuka America Pharmaceutical, Inc. 2019 Aimmune 2018 Foundation Medicine, Inc. 2018 Pacira BioSciences, Inc. 2003 Alcon Laboratories, Inc. 2006 Gilead Sciences 2018 Paratek Pharmaceuticals 2017 Alkermes, Inc. 1989 Genentech Inc. 1990 Pfizer Pharmaceuticals 2002 Allergan, Inc. 1983 GLAXOSMITHKLINE 2017 Pharmacyclics, LLC 2019 Almirall LLC 2013 Golden State Medical Supply, Inc. 2019 Portola Pharmaceuticals, Inc. 2019 Alnylam Pharmaceuticals 2019 Greenwich Biosciences 2019 Red One Medical 2019 Altarum Institute 2013 Gulf Coast Pharmaceuticals Plus, LLC 2009 Regenesis Biomedical, Inc. 2012 American Medical Depot 2008 Heritage Health Solutions, Inc. 2019 Relypsa, Inc. 2019 Aptive Resources LLC 2017 Hill-Rom Company 2011 Remund Group, LLC 2013 Arbor Pharmaceuticals, LLC 2018 Hu-Friedy Manufacturing Co 2018 Rigel Pharmaceuticals 2014 Argentum Medical, LLC 2019 Indivior 2016 Sage Products, LLC 2019 ASM Research, LLC 2019 ImmunoVation, LLC 2018 Sage Therapeutics 1986 Astellas Pharma US, Inc. 2019 Incyte Corporation 2000 Sanofi 1995 AstraZeneca 2015 Intercept Pharmaceuticals 2004 Siemens Medical Solutions 2018 Avanir Pharmaceuticals 2019 Ipsen Biopharmaceuticals, Inc. 2019 SK Life Science, Inc. 2017 Bausch Health Companies, Inc. 2018 IT Cadre 2002 Smith & Nephew, Inc. 1985 Baxter Healthcare Corporation 1989 J & J Health Care Systems, Inc. 2019 Sobi Inc. 1996 Bayer Corporation 2014 Jazz Pharmaceuticals Inc. -
New Contributions in Undergraduate Research
PSU McNair Scholars Online Journal Volume 11 Issue 1 Without Borders: Original Contributions Article 6 in Undergraduate Research 2017 Wings Outstretched: New Contributions in Undergraduate Research Follow this and additional works at: https://pdxscholar.library.pdx.edu/mcnair Let us know how access to this document benefits ou.y Recommended Citation (2017) "Wings Outstretched: New Contributions in Undergraduate Research," PSU McNair Scholars Online Journal: Vol. 11: Iss. 1, Article 6. https://doi.org/10.15760/mcnair.2017.01 This open access Full Issue is distributed under the terms of the Creative Commons Attribution-NonCommercial- ShareAlike 4.0 International License (CC BY-NC-SA 4.0). All documents in PDXScholar should meet accessibility standards. If we can make this document more accessible to you, contact our team. Portland State University McNair Research Journal 2017 Without Borders: Original Contributions in Undergraduate Research 2017 Ronald E. McNair Scholars Journal Portland State University 1 About the Program The Portland State University (PSU) Ronald E. McNair Scholars Program at Portland State University works with motivated and talented undergraduates who want to pursue PhDs. It introduces juniors and seniors who are first-generation and low income, and/or members of under-represented groups to academic research and to effective strategies for getting into and graduating from PhD programs. The McNair Scholars Program has academic-year activities and a full-time summer research internship. Scholars take academic and skills-building seminars and workshops during the year, and each scholar works closely with a faculty mentor on original research in the summer. Scholars present their research findings at the McNair Summer Symposium and at other conferences, and are encouraged to publish their papers in the McNair Journal and other scholarly publications. -
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 -
Chronic Lymphocytic Leukemia
Amsterdam, the Netherlands, June 14 – 17, 2012 Chronic lymphocytic leukemia - Clinical 1 assumed efficacy especially in high-risk situations (early relapse, unfavourable prognostic markers), was used in 202 patients. The overall survival in the CHOP-collective was significantly shorter than in the comparative group (p<0.0001) although median observation time was not significantly differ - 0144 ent. However, this observation might reflect a bias in the selection of high risk patients for this relapse treatment. No influence on survival was INFLUENCE OF DIFFERENT TREATMENT REGIMENS ON SURVIVAL IN observed in patients receiving a mitoxantrone-containing regimen at any PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA - A META-ANALY - time during the treatment course. Summary and Conclusions. This meta- SIS OF THE GERMAN CLL STUDY GROUP (GCLLSG) analysis shows that the advances in the development of strategies for first- S Isfort 1, P Cramer 2, J Bahlo 2, R Busch 3, K Fischer 2, AM Fink 2, V Goede 2, T line therapies result in prolongation of treatment-free and overall survival Elter 2, M Bergmann 4, M Stauch 5, S Stilgenbauer 4, CM Wendtner 6, M Hallek 2, for patients with CLL and need of treatment. Chemoimmunotherapies pro - B Eichhorst 2 long the survival independently of the time point of chemoimmunotherapy 1Department of Medicine IV, University Hospital Aachen, Aachen, Germany administration (for first-line therapy or relapse). 2Department I of Internal Medicine, University Hospital of Cologne, Cologne, Germany 3 Institute for Medical Statistic and Epidemiology, Technical University Munich, 0145 Munich, Germany 4 Department III of Internal Medicine, University Hospital Ulm, Ulm, Germany A SINGLE-ARM MULTI-CENTER TRIAL OF BENDAMUSTINE GIVEN 5 Private practice and day time clinic for Hematology and Oncology, Kronach, WITH OFATUMUMAB (BENDOFA) IN PATIENTS WITH REFRACTORY OR Kronach, Germany RELAPSED CHRONIC LYMPHOCYTIC LEUKEMIA. -
National Cancer Institute Cancer National
DIVISION OF CANCER TREATMENT AND DIAGNOSIS National Cancer Institute Cancer National PROGRAM ACCOMPLISHMENTS 2006 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health TABLE OF CONTENTS Foreword . iii Division of Cancer Treatment and Diagnosis Overview . .1 Major Ongoing Initiatives and Accomplishments . .7 Biometric Research Branch Overview . 11 Partnerships and Collaborations . 12 Scientific Advances . 17 Other Biostatistical Research . 24 Tools, Products, and Resources . 27 Cancer Diagnosis Program Overview . 29 Major Ongoing Initiatives . 30 Current Funding Opportunities . 34 Partnerships and Collaborations . 36 Scientific Advances . 39 Tools, Products, and Resources . 41 Cancer Imaging Program Overview . 45 Major Ongoing Initiatives . 47 Current Funding Opportunities . 54 Partnerships and Collaborations . 57 Scientific Advances . 61 Tools, Products, and Resources . 63 Cancer Therapy Evaluation Program Overview . 65 Major Ongoing Initiatives . 67 Significant Ongoing Clinical Trials . 71 Current Funding Opportunities . 73 Partnerships and Collaborations . 75 Scientific Advances . 79 Tools, Products, and Resources . 92 TABLE OF CONTENTS ■ i Developmental Therapeutics Program Overview . 95 New Initiatives . 97 Major Ongoing Initiatives . .100 Current Funding Opportunities . .104 Tools, Products, and Resources . .105 History-Marking Event . .114 Scientific Advances . .115 Radiation Research Program Overview . .119 Partnerships and Collaborations . .121 Scientific Advances . .127 Tools, Products, and Resources . .129