Jonathan Kitonsa, Abu-Baker Ggayi, Zacchaeus Anywaine, Eva Kisaakye, Laura Nsangi, Vincent Basajja, Mary Nyantaro, Deborah Watson-Jones, Georgi Shukarev, Ine Ilsbroux, Cynthia Robinson, Pontiano Kaleebu
BACKGROUND: The 2013-2016 Ebola epidemic in West Africa is the worst ever caused by Ebolaviruses with over 28,000 human cases and 11,325 deaths. The World Health Organisation (WHO) declared the epidemic a public health crisis that required accelerated development of novel interventions including vaccines. The Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit (MRC/UVRI & LSHTM Uganda Research Unit) was among the African research sites that implemented the VAC52150EBL1004 Ebola vaccine trial...
December 31, 2020: Global Health Action
Katia Abarca, Emma Rey-Jurado, Natalia Muñoz-Durango, Yaneisi Vázquez, Jorge A Soto, Nicolás M S Gálvez, Javier Valdés-Ferrada, Carolina Iturriaga, Marcela Urzúa, Arturo Borzutzky, Jaime Cerda, Luis Villarroel, Victoria Madrid, Pablo A González, José V González-Aramundiz, Susan M Bueno, Alexis M Kalergis
Background: Respiratory syncytial virus (RSV) is responsible for most respiratory tract infections and hospitalizations in infants and represents a significant economic burden for public health. The development of a safe, effective, and affordable vaccine is a priority for the WHO. Methods: We conducted a double-blinded, escalating-dose phase 1 clinical trial in healthy males aged 18-50 years to evaluate safety, tolerability, and immunogenicity of a recombinant Mycobacterium bovis BCG vaccine expressing the nucleoprotein of RSV (rBCG-N-hRSV)...
October 2020: EClinicalMedicine
Felisa Reyes-Ortega, Fiona Qiu, Elena K Schneider-Futschik
Ivacaftor-tezacaftor and ivacaftor-tezacaftor-elexacaftor are new breakthrough cystic fibrosis (CF) drug combinations that directly modulate the activity and trafficking of the defective CF transmembrane conductance regulator protein (CFTR) underlying the CF disease state. Currently, in the hospital setting, there are no therapeutic drug monitoring assays for these very expensive, albeit, life-saving drugs. A rapid and precise novel method for the quantification of ivacaftor, its metabolites, tezacaftor, and elexacaftor, in human plasma was developed and validated using multiple reaction monitoring mass spectrometry (MRM/MS)...
October 9, 2020: ACS Pharmacology & Translational Science
Marco Canevelli, Giulia Remoli, Federica Trentin, Gabriele Riccardi, Leonardo Tariciotti, Giovanni Risoleo, Antonio Ancidoni, Giuseppe Bruno, Matteo Cesari, Nicola Vanacore, Valeria Raparelli
The coronavirus disease 19 (COVID-19) pandemic poses a serious threat to the sustainability of healthcare systems and is currently having a significant effect on living conditions worldwide. No therapeutic agent has yet proven to be effective for the treatment of COVID-19. The management of this disease currently relies on supportive care and the off-label and compassionate use of antivirals and immunomodulators. Nevertheless, there has been a great worldwide effort to progress research and test the efficacy and safety/tolerability profiles of numerous candidate agents that may positively affect the various clinical syndromes associated with COVID-19...
2020: Frontiers in Medicine
You-Meng Sun, Ying Wang, Xin-Xing Sun, Jing Chen, Zhi-Ping Gong, Hai-Yan Meng
Background: Immune checkpoint inhibitors (ICIs) have transformed the treatment landscape among non-small-cell lung cancer (NSCLC) patients. The efficacy of ICI therapy in older patients (≥65 years) is controversial and not fully clarified. We performed a systematic review and meta-analysis to evaluate the efficacy of ICIs in patients with advanced or metastatic NSCLC based on age (<65 years vs. ≥65 years). Methods: A comprehensive literature search for eligible randomized control phase II/III trials that compared the efficacy of anti-PD-1/PD-L1 agents against chemotherapy in advanced or metastatic NSCLC patients...
2020: Frontiers in Oncology
Kameron Bechler, Kristina Shkirkova, Jeffrey L Saver, Sidney Starkman, Scott Hamilton, David S Liebeskind, Marc Eckstein, Samuel Stratton, Frank Pratt, Robin Conwit, Nerses Sanossian
Background: Cardiac adverse events are common among patients presenting with acute stroke and contribute to overall morbidity and mortality. Prophylactic measures for the reduction of cardiac adverse events in hospitalized stroke patients have not been well understood. We sought to investigate the effect of early initiation of high-dose intravenous magnesium sulfate on cardiac adverse events in stroke patients. Methods: This is a secondary analysis of the prehospital Field Administration of Stroke Therapy-Magnesium (FAST-MAG) randomized phase-3 clinical trial, conducted from 2005-2013...
2020: Cardiovascular Therapeutics
John M Seligson, Alexandra M Patron, Michael J Berger, R Donald Harvey, Nathan D Seligson
OBJECTIVE: To review the pharmacology, efficacy, and safety of sacituzumab govitecan (-hziy; IMMU-132, Trodelvy) for patients with metastatic triple-negative breast cancer (mTNBC) who have received at least 2 prior therapies for metastatic disease. DATA SOURCES: A literature search was conducted utilizing PubMed and MEDLINE databases, applicable published abstracts, and ongoing studies from between January 1, 1981, and September 3, 2020. Keywords included sacituzumab govitecan (-hziy), IMMU-132, Trop-2 (trophoblast cell-surface antigen 2), and TACSTD2 ...
October 17, 2020: Annals of Pharmacotherapy
Michael Staehler, Michael Stöckle, Daniel C Christoph, Arnulf Stenzl, Karin Potthoff, Marc-Oliver Grimm, Dunja Klein, Johanna Harde, Fabian Brüning, Peter J Goebell, Marinela Augustin, Frederik Roos, Iris Benz-Rüd, Norbert Marschner, Viktor Grünwald
MARC-2, a prospective, multicenter phase IV trial, aimed to investigate clinical outcomes in patients with metastatic renal cell carcinoma (mRCC) treated with everolimus after failure of one initial vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI) therapy and to identify subgroups benefiting most, based on clinical characteristics and biomarkers. Patients with clear cell mRCC failing one initial VEGFR-TKI received everolimus until progression or unacceptable toxicity. Primary endpoint was 6-month progression-free survival rate (6moPFS)...
October 18, 2020: International Journal of Cancer. Journal International du Cancer
Robert S Rahimi, Rifaat Safadi, Dominique Thabut, Kalyan Ram Bhamidimarri, Nikolaos Pyrsopoulos, Amy Potthoff, Stan Bukofzer, Jasmohan S Bajaj
BACKGROUND & AIMS: Hepatic encephalopathy (HE) is associated with increased morbidity, mortality, and healthcare resource use. In this phase 2b study, we evaluated the efficacy and safety of ornithine phenylacetate (OP), an ammonia scavenger, in hospitalized patients with cirrhosis, increased levels of ammonia at screening, and acute or overt HE. METHODS: We conducted a double-blind study of 231 patients with cirrhosis and HE at multiple sites in North America, Europe, Israel, and Australia from January 7, 2014, through December 29, 2016...
October 15, 2020: Clinical Gastroenterology and Hepatology
Joshua T Gamse, Wendy Freebern, Rashade Haynes Ii, Frank Simutis, Mary Pazian, James Crona, Helen G Haggerty, Michael Graziano, Roderick Todd Bunch
The OX40 receptor plays a crucial co-stimulatory role in T effector cell survival, expansion, cytokine production, and cytotoxicity to tumor cells; therefore, OX40 agonists are being evaluated as anti-cancer immunotherapies, especially in combination with checkpoint inhibitors. To support clinical development of BMS-986178 (an OX40 agonist antibody), two repeat-dose toxicity studies were conducted in cynomolgus monkeys. In the first study, BMS-986178 was administered intravenously (IV) once weekly for one month at doses from 30 to 120 mg/kg...
October 15, 2020: Toxicology and Applied Pharmacology
Min Zhao, Yun-Hua Zheng, Qi-Yuan Zhao, Wei Zheng, Jian-Hong Yang, He-Ying Pei, Ling Liu, Kong-Jun Liu, Lin-Lin Xue, De-Xin Deng, Lun Wang, Xu Ma, Su-Hong Fu, Ai-Hua Peng, Ming-Hai Tang, Yun-Zi Luo, Hao-Yu Ye, Li-Juan Chen
Magnolol and honokiol are the two major active ingredients with similar structure and anticancer activity from traditional Chinese medicine Magnolia officinalis, and honokiol is now in a phase I clinical trial (CTR20170822) for advanced non-small cell lung cancer (NSCLC). In search of potent lead compounds with better activity, our previous study has demonstrated that magnolol derivative C2, 3-(4-aminopiperidin-1-yl)methyl magnolol, has better activity than honokiol. Here, based on the core of 3-(4-aminopiperidin-1-yl)methyl magnolol, we synthesized fifty-one magnolol derivatives...
October 10, 2020: European Journal of Medicinal Chemistry
Omara Dogar, Ada Keding, Rhian Gabe, Anna-Marie Marshall, Rumana Huque, Deepa Barua, Razia Fatima, Amina Khan, Raana Zahid, Sonia Mansoor, Daniel Kotz, Melanie Boeckmann, Helen Elsey, Eva Kralikova, Steve Parrott, Jinshuo Li, Anne Readshaw, Aziz Sheikh, Kamran Siddiqi
BACKGROUND: Smoking cessation is important in patients with tuberculosis because it can reduce the high rates of treatment failure and mortality. We aimed to assess the effectiveness and safety of cystine as a smoking cessation aid in patients with tuberculosis in Bangladesh and Pakistan. METHODS: We did a randomised, double-blind, placebo-controlled, trial at 32 health centres in Bangladesh and Pakistan. Eligible patients were adults (aged >18 years in Bangladesh; aged >15 years in Pakistan) with pulmonary tuberculosis diagnosed in the previous 4 weeks, who smoked tobacco on a daily basis and were willing to stop smoking...
November 2020: Lancet Global Health
Junko Nakahira, Shoko Nakano, Toshiaki Minami
BACKGROUND: Alveolar recruitment maneuvers enable easily reopening nonaerated lung regions via a transient elevation in transpulmonary pressure. To evaluate the effect of these maneuvers on respiratory resistance, we used an oscillatory technique during mechanical ventilation. This study was conducted to assess the effect of the alveolar recruitment maneuvers on respiratory resistance under routine anesthesia. We hypothesized that respiratory resistance at 5 Hz (R5) after the maneuver would be decreased after the lung aeration...
October 17, 2020: BMC Anesthesiology
Roy S Herbst, Hendrik Tobias Arkenau, Johanna Bendell, Edward Arrowsmith, Martin Wermke, Andres Soriano, Nicolas Penel, Rafael Santana-Davila, Helge Bischoff, Ian Chau, Gu Mi, Hong Wang, Erik Rasmussen, David Ferry, Bo H Chao, Luis Paz-Ares
INTRODUCTION: Data of first-line ramucirumab plus pembrolizumab treatment of programmed death ligand 1 (PD-L1)-positive, non-small cell lung cancer (NSCLC; Cohort E) are reported (NCT02443324). METHODS: In this multicenter, open-label phase 1a/b trial, patients received ramucirumab 10 mg/kg and pembrolizumab 200 mg every 21 days for up to 35 cycles. PD-L1 positivity was defined as tumor proportion score (TPS) ≥1%. Exploratory NanoString biomarker analyses included three T-cell signatures (T-cell-inflamed, Gajewski, and effector T-cells) and CD274 gene expression...
October 14, 2020: Journal of Thoracic Oncology
Soumyajit Roy, Scott Grimes, Scott C Morgan, Daniel E Spratt, Libni Eapen, Robert M Mac Rae, Julia Malone, Julia Craig, Shawn Malone
BACKGROUND: The impact of treating physician on radiotherapy-related toxicity is unclear. We carried out a secondary analysis of a randomized controlled study to determine if the risk of radiotherapy-related late toxicities in prostate cancer (PCa) patients varies depending on the treating radiation oncologist. PATIENTS AND METHODS: This is a secondary analysis of a phase III randomized controlled study in which PCa patients with Gleason score ≤7, clinical stage T1b-T3a and prostate-specific antigen <30 ng/mL were randomized to receive androgen suppression for 6 months starting either 4 months before or concurrently with definitive prostate radiotherapy...
October 14, 2020: Practical Radiation Oncology
Kei Ito, Yujiro Nakajima, Tsuyoshi Onoe, Hiroaki Ogawa, Hideyuki Harada, Makoto Saito, Katsuyuki Karasawa
PURPOSE: The present multicenter, single-arm, phase II study aimed to prospectively evaluate the palliative efficacy of stereotactic body radiotherapy (SBRT) in patients with painful non-spine bone metastases. METHODS: Patients with painful (≥2 points on a 0-to-10 scale) non-spine bone metastases from a solid tumor were enrolled. The prescribed dose was 35 Gy in five fractions. The primary endpoint was overall pain response rate (complete and partial) as measured with reference to the International Consensus on Palliative Radiotherapy Endpoints guideline 6 months after the SBRT...
October 14, 2020: Practical Radiation Oncology
Peifeng Chen, Mingzhong Chen, Amritha Menon, Althaf I Hussain, Elizabeth Carey, Christopher Lee, Joe Horwitz, Sarah O'Connell, Johnathan W Cooper, Richard Schwartz, Daniel B Gowetski
Respiratory syncytial virus (RSV) is a highly contagious virus causing severe infection in infants and the elderly. Various approaches are being used to develop an effective RSV vaccine. The RSV fusion (F) subunit, particularly the cleaved trimeric pre-fusion F, is one of the most promising vaccine candidates under development. The pre-fusion conformation elicits the majority of neutralizing antibodies during natural infection. However, this pre-fusion conformation is metastable and prone to conversion to a post-fusion conformation, thus hindering the potential of this construct as a vaccine antigen...
October 14, 2020: Journal of Biotechnology
Tareq Al Baghdadi, Elizabeth Garrett-Mayer, Susan Halabi, Pam K Mangat, Patricia Rich, Eugene R Ahn, Seungjean Chai, Andrew L Rygiel, Olufunlayo Osayameh, Kaitlyn R Antonelli, Samiha Islam, Suanna S Bruinooge, Richard L Schilsky
BACKGROUND: TAPUR is a pragmatic, phase II basket study evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancers harboring genomic alterations known to be drug targets. Sunitinib is an oral multikinase inhibitor of FMS-like tyrosine kinase-3 (FLT-3), among other targets. Results from a cohort of patients with metastatic colorectal cancer (mCRC) with FLT-3 amplification treated with sunitinib are reported. OBJECTIVE: This study aimed to investigate whether patients with mCRC with FLT-3 amplification would be responsive to sunitinib, an oral multikinase inhibitor...
October 17, 2020: Targeted Oncology
Mariarosaria De Luca, Giorgio Bosso, Antonio Valvano, Vincenzo Guardasole, Amodio Botta, Vincenzo Carbone, Giovanni Carella, Andrea Del Buono, Giuseppe Di Giovanni, Biagio Fimiani, Franco Guarnaccia, Emanuela Lapice, Emilia Martedì, Giuseppe Memoli, Domenica Oliva, Geremia Romano, Antonio Cittadini, Giovanni Battista Zito, Ugo Oliviero
SCODIAC was a pilot study which revealed an increasing use of SGLT2i in 123 outpatients affected with Heart Failure (HF) and Type 2 Diabetes Mellitus. SCODIAC-II study, the second phase of the program, has been carried out to determine diagnostic and therapeutic pathways in a larger group of patients and to verify whether the use of innovative antidiabetic therapies could modify echocardiographic parameters and cardiovascular therapies. 406 HF-diabetic patients, referred to Cardiologists and Diabetologists of pertaining healthcare districts in Campania, were enrolled in this retrospective study and divided in Group A, composed of 136 patients with preserved Ejection Fraction (HF-pEF)(> 45%) and Group B, formed of 270 patients with reduced EF (HF-rEF)(≤ 45%)...
October 17, 2020: Internal and Emergency Medicine
Claudia Marchetti, Anna Fagotti, Vincenzo Tombolini, Giovanni Scambia, Francesca De Felice
BACKGROUND: Phase 3 randomized clinical trials have been designed to compare secondary cytoreductive surgery followed by systemic therapy with systemic therapy alone for management of patients with recurrent ovarian cancer. This study aimed to compare differences in clinical outcomes between these two treatment approaches. METHODS: The PRISMA statement was applied. Only phase 3 randomized clinical trials were included in the final analysis. RESULTS: Three randomized clinical trials (n = 1250 patients) were identified...
October 16, 2020: Annals of Surgical Oncology
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