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2. Multimodal NASH prognosis using 3D imaging flow cytometry and artificial intelligence to characterize liver cells

Author

Subramanian, Ramkumar, Tang, Rui, Zhang, Zunming, Joshi, Vaidehi, Miner, Jeffrey N, and Lo, Yu-Hwa

Subjects
Biochemistry and Cell Biology, Engineering, Biological Sciences, Liver Disease, Digestive Diseases, Chronic Liver Disease and Cirrhosis, Bioengineering, Hepatitis, Aetiology, 2.1 Biological and endogenous factors, Good Health and Well Being, Artificial Intelligence, Flow Cytometry, Humans, Imaging, Three-Dimensional, Non-alcoholic Fatty Liver Disease, Prognosis
Abstract

To improve the understanding of the complex biological process underlying the development of non-alcoholic steatohepatitis (NASH), 3D imaging flow cytometry (3D-IFC) with transmission and side-scattered images were used to characterize hepatic stellate cell (HSC) and liver endothelial cell (LEC) morphology at single-cell resolution. In this study, HSC and LEC were obtained from biopsy-proven NASH subjects with early-stage NASH (F2-F3) and healthy controls. Here, we applied single-cell imaging and 3D digital reconstructions of healthy and diseased cells to analyze a spatially resolved set of morphometric cellular and texture parameters that showed regression with disease progression. By developing a customized autoencoder convolutional neural network (CNN) based on label-free cell transmission and side scattering images obtained from a 3D imaging flow cytometer, we demonstrated key regulated cell types involved in the development of NASH and cell classification performance superior to conventional machine learning methods.

Published
2022

3. Lesinurad, a novel, oral compound for gout, acts to decrease serum uric acid through inhibition of urate transporters in the kidney

Author

Miner, Jeffrey N, Tan, Philip K, Hyndman, David, Liu, Sha, Iverson, Cory, Nanavati, Payal, Hagerty, David T, Manhard, Kimberly, Shen, Zancong, Girardet, Jean-Luc, Yeh, Li-Tain, Terkeltaub, Robert, and Quart, Barry

Subjects
Pharmacology and Pharmaceutical Sciences, Biomedical and Clinical Sciences, Complementary and Integrative Health, Clinical Research, Kidney Disease, 5.1 Pharmaceuticals, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Development of treatments and therapeutic interventions, Renal and urogenital, Cell Line, Gout, Humans, Kidney, Male, Organic Anion Transporters, Organic Cation Transport Proteins, Thioglycolates, Triazoles, Uric Acid, Uricosuric Agents, RDEA594, URAT1, Clinical Sciences, Immunology, Public Health and Health Services, Arthritis & Rheumatology, Clinical sciences
Abstract

BackgroundExcess body burden of uric acid promotes gout. Diminished renal clearance of uric acid causes hyperuricemia in most patients with gout, and the renal urate transporter (URAT)1 is important for regulation of serum uric acid (sUA) levels. The URAT1 inhibitors probenecid and benzbromarone are used as gout therapies; however, their use is limited by drug-drug interactions and off-target toxicity, respectively. Here, we define the mechanism of action of lesinurad (Zurampic®; RDEA594), a novel URAT1 inhibitor, recently approved in the USA and Europe for treatment of chronic gout.MethodssUA levels, fractional excretion of uric acid (FEUA), lesinurad plasma levels, and urinary excretion of lesinurad were measured in healthy volunteers treated with lesinurad. In addition, lesinurad, probenecid, and benzbromarone were compared in vitro for effects on urate transporters and the organic anion transporters (OAT)1 and OAT3, changes in mitochondrial membrane potential, and human peroxisome proliferator-activated receptor gamma (PPARγ) activity.ResultsAfter 6 hours, a single 200-mg dose of lesinurad elevated FEUA 3.6-fold (p

Published
2016

7. Supplementary Tables 1-3 from Multicenter Phase I Trial of the Mitogen-Activated Protein Kinase 1/2 Inhibitor BAY 86-9766 in Patients with Advanced Cancer

Author

Weekes, Colin D., primary, Von Hoff, Daniel D., primary, Adjei, Alex A., primary, Leffingwell, Diane P., primary, Eckhardt, S. Gail, primary, Gore, Lia, primary, Lewis, Karl D., primary, Weiss, Glen J., primary, Ramanathan, Ramesh K., primary, Dy, Grace K., primary, Ma, Wen W., primary, Sheedy, Beth, primary, Iverson, Cory, primary, Miner, Jeffrey N., primary, Shen, Zancong, primary, Yeh, Li-Tain, primary, Dubowy, Ronald L., primary, Jeffers, Michael, primary, Rajagopalan, Prabhu, primary, and Clendeninn, Neil J., primary

Published
2023
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8. Supplementary Figure S1 from Multicenter Phase I Trial of the Mitogen-Activated Protein Kinase 1/2 Inhibitor BAY 86-9766 in Patients with Advanced Cancer

Author

Weekes, Colin D., primary, Von Hoff, Daniel D., primary, Adjei, Alex A., primary, Leffingwell, Diane P., primary, Eckhardt, S. Gail, primary, Gore, Lia, primary, Lewis, Karl D., primary, Weiss, Glen J., primary, Ramanathan, Ramesh K., primary, Dy, Grace K., primary, Ma, Wen W., primary, Sheedy, Beth, primary, Iverson, Cory, primary, Miner, Jeffrey N., primary, Shen, Zancong, primary, Yeh, Li-Tain, primary, Dubowy, Ronald L., primary, Jeffers, Michael, primary, Rajagopalan, Prabhu, primary, and Clendeninn, Neil J., primary

Published
2023
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9. Supplementary Figure Legend from Multicenter Phase I Trial of the Mitogen-Activated Protein Kinase 1/2 Inhibitor BAY 86-9766 in Patients with Advanced Cancer

Author

Weekes, Colin D., primary, Von Hoff, Daniel D., primary, Adjei, Alex A., primary, Leffingwell, Diane P., primary, Eckhardt, S. Gail, primary, Gore, Lia, primary, Lewis, Karl D., primary, Weiss, Glen J., primary, Ramanathan, Ramesh K., primary, Dy, Grace K., primary, Ma, Wen W., primary, Sheedy, Beth, primary, Iverson, Cory, primary, Miner, Jeffrey N., primary, Shen, Zancong, primary, Yeh, Li-Tain, primary, Dubowy, Ronald L., primary, Jeffers, Michael, primary, Rajagopalan, Prabhu, primary, and Clendeninn, Neil J., primary

Published
2023
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10. Supplementary Table 4 from A Phase I Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Combination Therapy with Refametinib plus Sorafenib in Patients with Advanced Cancer

Author

Adjei, Alex A., primary, Richards, Donald A., primary, El-Khoueiry, Anthony, primary, Braiteh, Fadi, primary, Becerra, Carlos H.R., primary, Stephenson, Joe J., primary, Hezel, Aram F., primary, Sherman, Morris, primary, Garbo, Lawrence, primary, Leffingwell, Diane P., primary, Iverson, Cory, primary, Miner, Jeffrey N., primary, Shen, Zancong, primary, Yeh, Li-Tain, primary, Gunawan, Sonny, primary, Wilson, David M., primary, Manhard, Kimberly J., primary, Rajagopalan, Prabhu, primary, Krissel, Heiko, primary, and Clendeninn, Neil J., primary

Published
2023
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11. Data from Multicenter Phase I Trial of the Mitogen-Activated Protein Kinase 1/2 Inhibitor BAY 86-9766 in Patients with Advanced Cancer

Author

Weekes, Colin D., primary, Von Hoff, Daniel D., primary, Adjei, Alex A., primary, Leffingwell, Diane P., primary, Eckhardt, S. Gail, primary, Gore, Lia, primary, Lewis, Karl D., primary, Weiss, Glen J., primary, Ramanathan, Ramesh K., primary, Dy, Grace K., primary, Ma, Wen W., primary, Sheedy, Beth, primary, Iverson, Cory, primary, Miner, Jeffrey N., primary, Shen, Zancong, primary, Yeh, Li-Tain, primary, Dubowy, Ronald L., primary, Jeffers, Michael, primary, Rajagopalan, Prabhu, primary, and Clendeninn, Neil J., primary

Published
2023
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12. Supplementary Figure 2 from A Phase I Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Combination Therapy with Refametinib plus Sorafenib in Patients with Advanced Cancer

Author

Adjei, Alex A., primary, Richards, Donald A., primary, El-Khoueiry, Anthony, primary, Braiteh, Fadi, primary, Becerra, Carlos H.R., primary, Stephenson, Joe J., primary, Hezel, Aram F., primary, Sherman, Morris, primary, Garbo, Lawrence, primary, Leffingwell, Diane P., primary, Iverson, Cory, primary, Miner, Jeffrey N., primary, Shen, Zancong, primary, Yeh, Li-Tain, primary, Gunawan, Sonny, primary, Wilson, David M., primary, Manhard, Kimberly J., primary, Rajagopalan, Prabhu, primary, Krissel, Heiko, primary, and Clendeninn, Neil J., primary

Published
2023
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13. Supplementary Figure 1 from A Phase I Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Combination Therapy with Refametinib plus Sorafenib in Patients with Advanced Cancer

Author

Adjei, Alex A., primary, Richards, Donald A., primary, El-Khoueiry, Anthony, primary, Braiteh, Fadi, primary, Becerra, Carlos H.R., primary, Stephenson, Joe J., primary, Hezel, Aram F., primary, Sherman, Morris, primary, Garbo, Lawrence, primary, Leffingwell, Diane P., primary, Iverson, Cory, primary, Miner, Jeffrey N., primary, Shen, Zancong, primary, Yeh, Li-Tain, primary, Gunawan, Sonny, primary, Wilson, David M., primary, Manhard, Kimberly J., primary, Rajagopalan, Prabhu, primary, Krissel, Heiko, primary, and Clendeninn, Neil J., primary

Published
2023
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14. Supplementary Table 5 from A Phase I Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Combination Therapy with Refametinib plus Sorafenib in Patients with Advanced Cancer

Author

Adjei, Alex A., primary, Richards, Donald A., primary, El-Khoueiry, Anthony, primary, Braiteh, Fadi, primary, Becerra, Carlos H.R., primary, Stephenson, Joe J., primary, Hezel, Aram F., primary, Sherman, Morris, primary, Garbo, Lawrence, primary, Leffingwell, Diane P., primary, Iverson, Cory, primary, Miner, Jeffrey N., primary, Shen, Zancong, primary, Yeh, Li-Tain, primary, Gunawan, Sonny, primary, Wilson, David M., primary, Manhard, Kimberly J., primary, Rajagopalan, Prabhu, primary, Krissel, Heiko, primary, and Clendeninn, Neil J., primary

Published
2023
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15. Supplementary Table 3 from A Phase I Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Combination Therapy with Refametinib plus Sorafenib in Patients with Advanced Cancer

Author

Adjei, Alex A., primary, Richards, Donald A., primary, El-Khoueiry, Anthony, primary, Braiteh, Fadi, primary, Becerra, Carlos H.R., primary, Stephenson, Joe J., primary, Hezel, Aram F., primary, Sherman, Morris, primary, Garbo, Lawrence, primary, Leffingwell, Diane P., primary, Iverson, Cory, primary, Miner, Jeffrey N., primary, Shen, Zancong, primary, Yeh, Li-Tain, primary, Gunawan, Sonny, primary, Wilson, David M., primary, Manhard, Kimberly J., primary, Rajagopalan, Prabhu, primary, Krissel, Heiko, primary, and Clendeninn, Neil J., primary

Published
2023
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16. Supplementary Table 6 from A Phase I Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Combination Therapy with Refametinib plus Sorafenib in Patients with Advanced Cancer

Author

Adjei, Alex A., primary, Richards, Donald A., primary, El-Khoueiry, Anthony, primary, Braiteh, Fadi, primary, Becerra, Carlos H.R., primary, Stephenson, Joe J., primary, Hezel, Aram F., primary, Sherman, Morris, primary, Garbo, Lawrence, primary, Leffingwell, Diane P., primary, Iverson, Cory, primary, Miner, Jeffrey N., primary, Shen, Zancong, primary, Yeh, Li-Tain, primary, Gunawan, Sonny, primary, Wilson, David M., primary, Manhard, Kimberly J., primary, Rajagopalan, Prabhu, primary, Krissel, Heiko, primary, and Clendeninn, Neil J., primary

Published
2023
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17. Supplementary Table 1 from A Phase I Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Combination Therapy with Refametinib plus Sorafenib in Patients with Advanced Cancer

Author

Adjei, Alex A., primary, Richards, Donald A., primary, El-Khoueiry, Anthony, primary, Braiteh, Fadi, primary, Becerra, Carlos H.R., primary, Stephenson, Joe J., primary, Hezel, Aram F., primary, Sherman, Morris, primary, Garbo, Lawrence, primary, Leffingwell, Diane P., primary, Iverson, Cory, primary, Miner, Jeffrey N., primary, Shen, Zancong, primary, Yeh, Li-Tain, primary, Gunawan, Sonny, primary, Wilson, David M., primary, Manhard, Kimberly J., primary, Rajagopalan, Prabhu, primary, Krissel, Heiko, primary, and Clendeninn, Neil J., primary

Published
2023
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18. Supplementary Table 2 from A Phase I Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Combination Therapy with Refametinib plus Sorafenib in Patients with Advanced Cancer

Author

Adjei, Alex A., primary, Richards, Donald A., primary, El-Khoueiry, Anthony, primary, Braiteh, Fadi, primary, Becerra, Carlos H.R., primary, Stephenson, Joe J., primary, Hezel, Aram F., primary, Sherman, Morris, primary, Garbo, Lawrence, primary, Leffingwell, Diane P., primary, Iverson, Cory, primary, Miner, Jeffrey N., primary, Shen, Zancong, primary, Yeh, Li-Tain, primary, Gunawan, Sonny, primary, Wilson, David M., primary, Manhard, Kimberly J., primary, Rajagopalan, Prabhu, primary, Krissel, Heiko, primary, and Clendeninn, Neil J., primary

Published
2023
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31. Systematic genetic analysis of early-onset gout: ABCG2 is the only associated locus

Author

Zaidi, Faseeh, primary, Narang, Ravi K, additional, Phipps-Green, Amanda, additional, Gamble, Greg G, additional, Tausche, Anne-Katherin, additional, So, Alexander, additional, Riches, Philip, additional, Andres, Mariano, additional, Perez-Ruiz, Fernando, additional, Doherty, Michael, additional, Janssen, Matthijs, additional, Joosten, Leo A B, additional, Jansen, Tim L, additional, Kurreeman, Fina, additional, Torres, Rosa J, additional, McCarthy, Geraldine M, additional, Miner, Jeffrey N, additional, Stamp, Lisa K, additional, Merriman, Tony R, additional, and Dalbeth, Nicola, additional

Published
2020
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33. Searching For SARA

Author

Chapman, Mark S., primary, Chang, William Y., additional, Negro-Vilar, Andres, additional, and Miner, Jeffrey N., additional

Published
2004
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36. A genome-wide association study of gout in people of European ancestry

Author

R. Merriman, Tony, Cadzow, Murray, E. Merriman, Marilyn, Phipps-Green, Amanda, Topless, Ruth, Abhishek, Abhishek, A. Bradbury, Linda, BUCHANAN, RUSSELL, Cremin, Katie, de Zoysa, Janak, Doherty, Michael, Hill, Catherine, Huizinga, Tom W.J., Jansen, Tim, Janssen, M., A.B. Joosten, Leo, Kurreeman, Fina, Lester, Susan, Lioté, Frederic, Macartney-Coxson, Donia, Matsuo, Hirotaka, McCarthy, Geraldine M, McCormick, Sally, Murphy, Rinki, Pavelka, Karel, Perez-Ruiz, Fernando, Puig, Juan, RDJ Radstake, Timothy, Riches, Philip, Rischmueller, Maureen, Roddy, Edward, Smith, Malcolm, A. Stahl, Eli, Stibůrková, Blanka, Stubbs, Richard, Tausche, Anne-Kathrin, Torres, Rosario, Walker, Rob, Yamamoto, Kentaro, Brown, Matthew A., K. Choi, Hyon, Dalbeth, Nicola, Miner, Jeffrey N., So, Alexander, K. Stamp, Lisa, and Major, Tanya

Subjects
Genetics not elsewhere classified, Anthropological genetics, Behavioural genetics
Abstract

Background/Purpose: Genome wide association studies (GWAS) have provided considerable insight into the molecular control of urate levels. However, less is known about the progression from asymptomatic hyperuricemia to gout. Our aim was to conduct a GWAS for gout in people of European ancestry using the largest number of cases of gout to date. Methods: This GWAS (7,431 cases and 105,631 controls) was comprised of three data sets: a mixed New Zealand (NZ), Eurogout, and Ardea Biosciences group (3,961 cases; 1,547 controls; genotyped using the Illumina CoreExome v24 array, 547,644 markers), a composite set from the Health Professionals Follow-Up (HPFS) and NursesÕ Health Studies (NHS) (1,038 cases; 1,095 controls; genotyped using the Illumina OmniExpress v12 array, 730,525 markers), and UK Biobank (2,432 cases; 102,989 controls; genotyped using an Affymetrix Axiom array, 820,967 markers). The UK Biobank genotypes were imputed to ~73.3M SNPs. Neither the NZ/Eurogout/Ardea nor NHS/HPFS genotype sets were imputed. Markers found within all three data sets (234,062) were identified and associated with gout (adjusted for sex and age), within each data set separately, using PLINK v1.9. An inverse-variance weighted meta-analysis of the results was then performed using the meta v4.4 package within R v3.2.3. The overall genome inflation factor was 0.90. Results: There were nine loci with experiment-wide significance (0.05/234,062; P < 2×10-7) for association with gout: ABCG2 (OR=1.77), SLC2A9 (OR=1.69), GCKR (OR=1.24), MLXIPL (OR=1.18), SLC17A1-A4 (OR=1.22), SLC16A9 (OR=1.18), SLC22A12 (OR=1.16), PDZK1 (OR=1.16), TRIM46 (OR=1.15). All nine of these loci have been previously associated with serum urate levels in genome-wide studies with the urate-increasing alleles also associated with increased risk of gout in this study. Conclusion: Our data emphasize the central importance of genetic involvement in serum urate levels, compared to the genetic involvement in MSU crystal formation, or the innate immune response, in determining gout.

Published
2019
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45. Antitumour activity of a potent MEK inhibitor RDEA119/BAY 869766 combined with rapamycin in human orthotopic primary pancreatic cancer xenografts

Author

Miner Jeffrey N, Chapman Mark S, Chang Qing, and Hedley David W

Subjects
Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Background Combining MEK inhibitors with other signalling pathway inhibitors or conventional cytotoxic drugs represents a promising new strategy against cancer. RDEA119/BAY 869766 is a highly potent and selective MEK1/2 inhibitor undergoing phase I human clinical trials. The effects of RDEA119/BAY 869766 as a single agent and in combination with rapamycin were studied in 3 early passage primary pancreatic cancer xenografts, OCIP19, 21, and 23, grown orthotopically. Methods Anti-cancer effects were determined in separate groups following chronic drug exposure. Effects on cell cycle and downstream signalling were examined by flow cytometry and western blot, respectively. Plasma RDEA119 concentrations were measured to monitor the drug accumulation in vivo. Results RDEA119/BAY 869766 alone or in combination with rapamycin showed significant growth inhibition in all the 3 models, with a significant decrease in the percentage of cells in S-phase, accompanied by a large decrease in bromodeoxyuridine labelling and cell cycle arrest predominantly in G1. The S6 ribosomal protein was inhibited to a greater extent with combination treatment in all the three models. Blood plasma pharmacokinetic analyses indicated that RDEA119 levels achieved in vivo are similar to those that produce target inhibition and cell cycle arrest in vitro. Conclusions Agents targeting the ERK and mTOR pathway have anticancer activity in primary xenografts, and these results support testing this combination in pancreatic cancer patients.

Published
2010
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46. Pharmacokinetics, pharmacodynamics, and tolerability of verinurad, a selective uric acid reabsorption inhibitor, in healthy Japanese and non-Asian male subjects

Author

Hall,Jesse, Gillen,Michael, Liu,Sha, Miner,Jeffrey N, Valdez,Shakti, Shen,Zancong, Lee,Caroline, Hall,Jesse, Gillen,Michael, Liu,Sha, Miner,Jeffrey N, Valdez,Shakti, Shen,Zancong, and Lee,Caroline

Abstract

Jesse Hall,1 Michael Gillen,2 Sha Liu,1 Jeffrey N Miner,1 Shakti Valdez,1 Zancong Shen,1 Caroline Lee1 1Ardea Biosciences, Inc., San Diego, CA, USA; 2AstraZeneca, Gaithersburg, MD, USA Purpose: Verinurad (RDEA3170) is a selective uric acid reabsorption inhibitor in clinical development for treatment of gout and asymptomatic hyperuricemia. This study evaluated verinurad pharmacokinetics, pharmacodynamics, and tolerability in healthy Japanese and non-Asian adult male subjects.Methods: This was a Phase I, randomized, single-blind, placebo-controlled study. Panels of 8 Japanese subjects were randomized to receive oral verinurad (2.5–15 mg) or placebo administered as a single dose in a fasted and fed state and as once-daily doses for 7 days in a fed state. Eight non-Asian subjects received verinurad 10 mg as a single dose (fasted and fed) and multiple doses in the fed state. Serial plasma/serum and urine samples were assayed for verinurad and uric acid. Safety was assessed by adverse events and laboratory data.Results: Of 48 randomized subjects, 46 (Japanese, 39; non-Asian, 7) completed the study. Following single or multiple doses in Japanese subjects, maximum plasma concentration (Cmax) and area under the plasma concentration–time curve (AUC) increased in a near dose-proportional manner. Time to Cmax (Tmax) was ~1.25–2.0 hours with fasting. A moderate-fat meal delayed Tmax (range 3.0–5.0 hours) and had a variable effect on AUC (0%–97% increase) and Cmax (0%–26% increase) across the dose groups. Following multiple verinurad 10 mg doses, Cmax and AUC were 38% and 23% higher, respectively, in Japanese vs non-Asian subjects, largely due to body weight differences. Mean reduction of serum urate following multiple verinurad 10 mg doses was 46% and 44% after 24 hours in Japanese and non-Asian subjects, respectively. Verinurad was well tolerated at all doses.Conclusion: Verinurad monotherapy lowered serum urate and wa

Published
2018

47. A Genome-Wide Association Study of Gout in People of European Ancestry

Author

Merriman, Tony R., Cadzow, Murray, Merriman, Marilyn E., Phipps-Green, Amanda, Topless, Ruth, Abhishek, Abhishek, Mariano Andrés, Bradbury, Linda A., Buchanan, Russell, Cremin, Katie, Guzman, Erika, Zoysa, Janak, Doherty, Michael, Hill, Catherine, Huizinga, Tom W. J., Jansen, Tim, Janssen, M., Joosten, Leo A. B., Kurreeman, Fina, Lester, Susan, Liote, Frederic, Macartney-Coxson, Donia, Matsuo, Hirotaka, Mccarthy, Geraldine M., Mccormick, Sally, Murphy, Rinki, Pavelka, Karel, Perez-Ruiz, Fernando, Puig, Juan, Radstake, Timothy R. D. J., Riches, Philip, Rischmueller, Maureen, Roddy, Edward, Smith, Malcolm, Stahl, Eli A., Stiburkova, Blanka, Stubbs, Richard, Tausche, Anne-Kathrin, Torres, Rosa, Walker, Rob, Yamamoto, Ken, Brown, Matthew A., Choi, Hyon K., Dalbeth, Nicola, Miner, Jeffrey N., So, Alexander, Stamp, Lisa K., and Major, Tanya

Published
2017

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