Article
Hematology
Julie Kanter, R. Clark Brown, Cynthia Norris, Santosh M. Nair, Abdullah Kutlar, Deepa Manwani, Nirmish Shah, Chiaki Tanaka, Shankaranand Bodla, Gessami Sanchez-Olle, Urs Albers, Darla Liles
Summary: This study analyzed the pharmacokinetics, pharmacodynamics, safety, and efficacy of crizanlizumab in patients with sickle cell disease. The results demonstrated the sustained efficacy and long-term safety of the drug in treating sickle cell disease.
Article
Pharmacology & Pharmacy
Sang-Hwan Ji, Ki Young Huh, Jaeseong Oh, Hee-Jeong Jeong, Young-Eun Jang, Eun-Hee Kim, Ji-Hyun Lee, Jin-Tae Kim, Hee-Soo Kim
Summary: This study investigated the pharmacokinetics and pharmacodynamics of sugammadex in Korean children. The results showed that the recommended dose of 2 mg/kg of sugammadex could be safely administered for reversing moderate neuromuscular blockade. Some differences in the pharmacokinetics of sugammadex were observed according to age.
FRONTIERS IN PHARMACOLOGY
(2023)
Article
Immunology
Elise D. Pieterman, Lina Keutzer, Aart van der Meijden, Sanne van den Berg, Han Wang, Matthew D. Zimmerman, Ulrika S. H. Simonsson, Hannelore Bax, Jurriaan E. M. de Steenwinkel
Summary: The study compared the efficacy of an all oral drug regimen (BDL) with a standard regimen (HRZE) on the mycobacterial load in the lungs and spleen of tuberculosis-infected mice, showing that BDL was more effective and could be a valuable option for the treatment of drug-resistant tuberculosis.
JOURNAL OF INFECTIOUS DISEASES
(2021)
Review
Pharmacology & Pharmacy
Li Zhou, Micaela B. Reddy, Rajendar K. Mittapalli, Jing Yang, Donghua Yin
Summary: Combination therapies are commonly evaluated in the clinical development of oncology investigational agents, and the design needs to consider factors such as drug interactions and benefit/risk to study participants. This report proposes application scenarios for different trial designs and emphasizes the importance of generating robust exposure-response data for optimal dose selection.
CLINICAL PHARMACOLOGY & THERAPEUTICS
(2023)
Review
Pharmacology & Pharmacy
Joseph A. Piscatelli, Jisun Ban, Andrew T. Lucas, William C. Zamboni
Summary: Major developments in nanomedicines, such as nanoparticles and conjugates, have revolutionized drug delivery capabilities, but there is considerable inter-patient variability seen in the systemic disposition, tumor delivery, and pharmacological effects of NP agents. Evaluating fundamental factors influencing NP disposition is crucial for clinical development.
Article
Microbiology
Kendra K. Radtke, Jacqueline P. Ernest, Nan Zhang, Nicole C. Ammerman, Eric Nuermberger, Robert Belknap, Rosanna Boyd, Timothy R. Sterling, Rada M. Savic
Summary: The study identified the optimal rifapentine dose for a 6-week monotherapy regimen and predicted clinical efficacy, suggesting that a 600-mg daily dose for 6wP may result in equal or better efficacy than 1HP and 3HP for LTBI treatment, without the potential added toxicity of isoniazid.
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY
(2021)
Article
Endocrinology & Metabolism
Ki Young Huh, Jun Gi Hwang, Wonjung Shin, Seungjae Baek, JaeDuk Choi, Nora Lee, Young Min Cho, Howard Lee
Summary: HM15136, a novel long-acting glucagon analogue, was shown to be safe and well tolerated in doses ranging from 10-120 μg/kg in a randomized, double-blind, placebo-controlled study. It increased blood glucose levels and suppressed the secretion of endogenous glucagon.
DIABETES OBESITY & METABOLISM
(2022)
Article
Endocrinology & Metabolism
Susanna Bianzano, Andrea Henrich, Lena Herich, Brigitte Kalsch, Donald Sarubbi, Friedeborg Seitz, Thomas Forst
Summary: Two Phase I studies showed that BI 1356225, a GOAT inhibitor, was well-tolerated in healthy males and subjects with overweight/obesity. However, treatment with BI 1356225 for 28 days did not lead to significant reduction in bodyweight or changes in appetite, eating control, or energy intake.
METABOLISM-CLINICAL AND EXPERIMENTAL
(2023)
Article
Microbiology
Ivone Jimenez-Toro, Carlos A. Rodriguez, Andres F. Zuluaga, Julian D. Otalvaro, Hector Perez-Madrid, Omar Vesga
Summary: Combination therapy with ampicillin plus ceftriaxone is the first-line treatment for severe infections caused by Enterococcus faecalis, but the pharmacokinetic/pharmacodynamic index linked to its efficacy has not been defined yet, hindering dose optimization in clinical settings.
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY
(2023)
Article
Endocrinology & Metabolism
Wonjung Shin, Marcus Hompesch, JinHee Byeon, Seohyun Kang, Jaehyuk Choi, Seungjae Baek
Summary: This study evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of a novel long-acting glucagon analogue HM15136 in overweight/obese patients with co-morbidities, with and without type 2 diabetes (T2D). The results showed that HM15136 had good safety and tolerability in patients with dyslipidaemia and/or hypertension, but its use in patients with T2D may cause hyperglycaemia.
DIABETES OBESITY & METABOLISM
(2023)
Article
Pharmacology & Pharmacy
Brian Hess, William Townsend, Weiyun Ai, Anastasios Stathis, Melhem Solh, Juan Pablo Alderuccio, David Ungar, Sam Liao, Lori Liao, Lisa Khouri, Xiaoyan Zhang, Joseph Boni
Summary: An integrated population pharmacokinetic model was developed to investigate the pharmacokinetics and exposure-response relationships of loncastuximab tesirine in relapsed/refractory B cell non-Hodgkin lymphoma. The model utilized recommended dosing schedules and data from phase 1 and 2 studies, exploring associations between exposure, efficacy, and adverse events. The model supported the recommended dosing schedule and highlighted factors influencing drug exposure and response.
Article
Pharmacology & Pharmacy
Gunavanthi D. Boorgula, Laxmi U. M. R. Jakkula, Tawanda Gumbo, Bockgie Jung, Shashikant Srivastava
Summary: The study compared microbial kill and resistance emergence of different rifamycins in the treatment of pulmonary MAC infection. Results showed no significant difference in efficacy and resistance suppression among the three rifamycins tested, and monotherapy with rifamycins was ineffective and led to drug resistance development.
FRONTIERS IN PHARMACOLOGY
(2021)
Article
Immunology
John P. O'Donnell, Sujata M. Bhavnani
Summary: Sulbactam-durlobactam is a combination of beta-lactam and beta-lactamase inhibitor that is being developed for the treatment of Acinetobacter infections, including multidrug-resistant strains. Sulbactam has intrinsic antibacterial activity against Acinetobacter, but its effectiveness has been reduced by increasing beta-lactamase-mediated resistance. Durlobactam, a rationally designed beta-lactamase inhibitor, effectively restores susceptibility to resistant isolates when combined with sulbactam. This review discusses the pharmacokinetic/pharmacodynamic relationship of the combination in nonclinical infection models and aids in determining effective dose regimens for humans.
CLINICAL INFECTIOUS DISEASES
(2023)
Article
Endocrinology & Metabolism
Qi Pan, Xiaoxia Wang, Wenjia Li, Xiaofeng Chen, Yulei Zhuang, Qinghong Zhou, Yuhui Huang, Yijie Zhou, Li Lan, Zhijie Wang, Wenjia Wang, Juan Hong, Wei-Hua Hao, Yu-Tsai Yang, Lixin Guo
Summary: This study aimed to verify whether the oral insulin N11005 is used as a prandial insulin by comparing its pharmacokinetics (PK), pharmacodynamics (PD), and safety profiles with a short-acting biosynthetic human insulin (Novolin R). A total of 12 healthy Chinese male subjects were enrolled in the study, and the results showed that N11005 has similar PD characteristics to prandial insulins, with a faster onset of action and comparable duration of action to the reference insulin. The study also demonstrated the safety and tolerability of N11005.
FRONTIERS IN ENDOCRINOLOGY
(2023)
Review
Public, Environmental & Occupational Health
Subhrojyoti Bhowmick, Amit Dang, B. N. Vallish, Sumit Dang
Summary: This review examined the safety and efficacy of Ivermectin (IVM) and doxycycline (DOXY) as monotherapy and combination therapy in COVID-19 management. The evidence on the efficacy of IVM, DOXY, or their combination in COVID-19 management is not strong enough to draw definitive conclusions.
Article
Oncology
Emmanuel S. Antonarakis, Josep M. Piulats, Marine Gross-Goupil, Jeffrey Goh, Kristiina Ojamaa, Christopher J. Hoimes, Ulka Vaishampayan, Ranaan Berger, Ahmet Sezer, Tuomo Alanko, Ronald de Wit, Chunde Li, Aurelius Omlin, Giuseppe Procopio, Satoshi Fukasawa, Ken-ichi Tabata, Se Hoon Park, Susan Feyerabend, Charles G. Drake, Haiyan Wu, Ping Qiu, Jeri Kim, Christian Poehlein, Johann Sebastian de Bono
JOURNAL OF CLINICAL ONCOLOGY
(2020)
Article
Oncology
Bradley A. McGregor, Rana R. McKay, David A. Braun, Lillian Werner, Kathryn P. Gray, Abdallah Flaifel, Sabina Signoretti, Michelle S. Hirsch, John A. Steinharter, Ziad Bakouny, Ronan Flippot, Xiao X. Wei, Atish Choudhury, Kerry Kilbridge, Gordon J. Freeman, Eliezer Van Allen, Lauren C. Harshman, David F. McDermott, Ulka Vaishampayan, Toni K. Choueiri
JOURNAL OF CLINICAL ONCOLOGY
(2020)
Article
Oncology
C. N. Sternberg, F. Saad, J. N. Graff, A. Peer, U. N. Vaishampayan, E. Leung, E. Rosenbaum, H. Gurney, R. J. Epstein, I. D. Davis, B. Wu, L. Trandafir, V. J. Wagner, M. Hussain
ANNALS OF ONCOLOGY
(2020)
Article
Oncology
J. Connor Wells, Jeffrey Graham, Benoit Beuselinck, Georg A. Bjarnason, Frede Donskov, Aaron R. Hansen, Rana R. McKay, Ulka Vaishampayan, Guillermo De Velasco, Mei S. Duh, Lynn Huynh, Catherine Nguyen, Giovanni Zanotti, Krishnan Ramaswamy, Toni K. Choueiri, Daniel Y. C. Heng
CLINICAL GENITOURINARY CANCER
(2020)
Article
Oncology
Cristiane Decat Bergerot, Errol J. Philip, Paulo Gustavo Bergerot, JoAnn Hsu, Nazli Dizman, Megan Salgia, Nicholas Salgia, Ulka Vaishampayan, Dena Battle, Matthew Loscalzo, William Dale, Sumanta Kumar Pal
Summary: This study found discrepancies between patient- and provider-reported ECOG PS, with clinicians tending to overestimate ECOG PS compared to patients. Patients' self-reported ECOG PS was associated with poorer psychosocial outcomes, while clinician-reported ECOG PS was linked to worse physical and functional well-being as well as higher rates of depression.
Article
Oncology
Brian A. Costello, Nrupen A. Bhavsar, Yousef Zakharia, Sumanta K. Pal, Ulka Vaishampayan, Heather Jim, Mayer N. Fishman, Ana M. Molina, Christos E. Kyriakopoulos, Che-Kai Tsao, Leonard J. Appleman, Benjamin A. Gartrell, Arif Hussain, Walter M. Stadler, Neeraj Agarwal, Russell K. Pachynski, Thomas E. Hutson, Hans J. Hammers, Christopher W. Ryan, Jack Mardekian, Azah Borham, Daniel J. George, Michael R. Harrison
Summary: The Metastatic Renal Cell Carcinoma Registry provides prospective data on real-world treatment patterns and outcomes in patients with metastatic renal cell carcinoma (mRCC). Initial findings suggest a focus on efficacy over quality of life and toxicity, indicating the need for further data and education on these endpoints.
CLINICAL GENITOURINARY CANCER
(2022)
Article
Oncology
Sumanta K. Pal, Bradley McGregor, Cristina Suarez, Che-Kai Tsao, William Kelly, Ulka Vaishampayan, Lance Pagliaro, Benjamin L. Maughan, Yohann Loriot, Daniel Castellano, Sandy Srinivas, Rana R. McKay, Robert Dreicer, Thomas Hutson, Sarita Dubey, Scott Werneke, Ashok Panneerselvam, Dominic Curran, Christian Scheffold, Toni K. Choueiri, Neeraj Agarwal
Summary: The study showed that the combination of cabozantinib plus atezolizumab has promising clinical activity and acceptable tolerability in patients with advanced ccRCC and nccRCC. Disease control was observed across dose levels and histologic subtypes.
JOURNAL OF CLINICAL ONCOLOGY
(2021)
Article
Oncology
Ulka N. Vaishampayan, Archana Thakur, Wei Chen, Abhinav Deol, Meera Patel, Kimberlee Dobson, Brenda Dickow, Dana Schalk, Amy Schienschang, Sarah Whitaker, Amanda Polend, Joseph A. Fontana, Elisabeth I. Heath, Lawrence G. Lum
Summary: This study aimed to evaluate the safety and efficacy of the combination of HER2 bispecific antibody (HER2Bi)-armed activated T cells (HER2 BAT) and programmed death 1 inhibitor, pembrolizumab, in the treatment of metastatic castration-resistant prostate cancer (mCRPC). The results showed that this combination therapy had good safety and efficacy in mCRPC patients, indicating the need for further investigation.
CLINICAL CANCER RESEARCH
(2023)
Article
Oncology
Joseph W. Kim, Rana R. McKay, Marc R. Radke, Shilin Zhao, Mary-Ellen Taplin, Nancy B. Davis, Paul Monk, Leonard J. Appleman, Primo N. Lara, Ulka N. Vaishampayan, Jingsong Zhang, Asit K. Paul, Glenn Bubley, Eliezer M. Van Allen, Serhan Unlu, Ying Huang, Massimo Loda, Geoffrey I. Shapiro, Peter M. Glazer, Patricia M. LoRusso, S. Percy Ivy, Yu Shyr, Elizabeth M. Swisher, Daniel P. Petrylak
Summary: The study investigated the clinical outcomes of combining Cediranib with olaparib in patients with prostate cancer. The results showed that the combination improved radiographic progression-free survival in patients with metastatic castration-resistant prostate cancer compared to olaparib alone. However, it was also associated with a higher incidence of adverse events.
JOURNAL OF CLINICAL ONCOLOGY
(2023)
Meeting Abstract
Oncology
Thomas E. Hutson, M. Dror Michaelson, Timothy M. Kuzel, Neeraj Agarwal, Ana M. Molina, James J. Hsieh, Ulka N. Vaishampayan, Sharon Xie, Urmi Bapat, Rohit K. Jain, Mayer N. Fishman
JOURNAL OF CLINICAL ONCOLOGY
(2020)
Meeting Abstract
Oncology
Meera Patel, Lawrence G. Lum, Abhinav Deol, Archana Thakur, Elisabeth I. Heath, Wei Chen, Kimberlee Dobson, Joseph A. Fontana, Ulka N. Vaishampayan
JOURNAL OF CLINICAL ONCOLOGY
(2020)
Meeting Abstract
Oncology
Emmanuel S. Antonarakis, Josep M. Piulats, Marine Gross-Goupil, Jeffrey C. Goh, Ulka N. Vaishampayan, Ronald De Wit, Tuomo Alanko, Satoshi Fukasawa, Kenichi Tabata, Susan Feyerabend, Raanan Berger, Helen Wu, Jeri Kim, Charles Schloss, Johann S. De Bono
JOURNAL OF CLINICAL ONCOLOGY
(2020)
Article
Oncology
Kennedy Iheanacho, Ulka Vaishampayan
CLINICAL ADVANCES IN HEMATOLOGY & ONCOLOGY
(2020)
Meeting Abstract
Oncology
Julie Nicole Graff, Emmanuel S. Antonarakis, Christopher J. Hoimes, Scott T. Tagawa, Clara Hwang, Deepak Kilari, A. J. Ten Tije, Aurelius Gabriel Omlin, Raymond S. McDermott, Ulka N. Vaishampayan, Anthony Elliott, Helen Wu, Jeri Kim, Charles Schloss, Johann S. De Bono
JOURNAL OF CLINICAL ONCOLOGY
(2020)
Article
Oncology
Nieves Martinez Chanza, Lillian Werner, Elizabeth Plimack, Evan Y. Yu, Ajjai S. Alva, Simon J. Crabb, Thomas Powles, Jonathan E. Rosenberg, Jack Baniel, Ulka N. Vaishampayan, Dominik R. Berthold, Sylvain Ladoire, Syed A. Hussain, Matthew Milowsky, Neeraj Agarwal, Andrea Necchi, Sumanta K. Pal, Cora N. Sternberg, Joaquim Bellmunt, Matthew D. Galsky, Lauren C. Harshman
EUROPEAN UROLOGY ONCOLOGY
(2020)