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6. eTRANSAFE: data science to empower translational safety assessment

Author

Sanz, Ferran, Pognan, François, Steger-Hartmann, Thomas, Díaz, Carlos, Asakura, Shoji, Amberg, Alexander, Bécourt-Lhote, Nathalie, Blomberg, Niklas, Bosc, Nicolas, Briggs, Katharine, Bringezu, Frank, Brulle-Wohlhueter, Claire, Brunak, Søren, Bueters, Ruud, Callegaro, Giulia, Capella-Gutierrez, Salvador, Centeno, Emilio, Corvi, Javier, Cronin, Mark T. D., Drew, Philip, Duchateau-Nguyen, Guillemette, Ecker, Gerhard F., Escher, Sylvia, Felix, Eloy, Ferreiro, Miguel, Frericks, Markus, Furlong, Laura I., Geiger, Robert, George, Catherine, Grandits, Melanie, Ivanov-Draganov, Dragomir, Kilgour-Christie, Jean, Kiziloren, Tevfik, Kors, Jan A., Koyama, Naoki, Kreuchwig, Annika, Leach, Andrew R., Mayer, Miguel-Angel, Monecke, Peter, Muster, Wolfgang, Nakazawa, Chihiro Miyamoto, Nicholson, Gavin, Parry, Rowan, Pastor, Manuel, Piñero, Janet, Oberhauser, Nils, Ramírez-Anguita, Juan Manuel, Rodrigo, Adrián, Smajic, Aljosa, Schaefer, Markus, Schieferdecker, Sebastian, Soininen, Inari, Terricabras, Emma, Trairatphisan, Panuwat, Turner, Sean C., Valencia, Alfonso, van de Water, Bob, van der Lei, Johan L., van Mulligen, Erik M., Vock, Esther, and Wilkinson, David

Published
2023
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13. eTRANSAFE:data science to empower translational safety assessment

Author

Sanz, Ferran, Pognan, François, Steger-Hartmann, Thomas, Díaz, Carlos, Asakura, Shoji, Amberg, Alexander, Bécourt-Lhote, Nathalie, Blomberg, Niklas, Bosc, Nicolas, Briggs, Katharine, Bringezu, Frank, Brulle-Wohlhueter, Claire, Brunak, Søren, Bueters, Ruud, Callegaro, Giulia, Capella-Gutierrez, Salvador, Centeno, Emilio, Corvi, Javier, Cronin, Mark T.D., Drew, Philip, Duchateau-Nguyen, Guillemette, Ecker, Gerhard F., Escher, Sylvia, Felix, Eloy, Ferreiro, Miguel, Frericks, Markus, Furlong, Laura I., Geiger, Robert, George, Catherine, Grandits, Melanie, Ivanov-Draganov, Dragomir, Kilgour-Christie, Jean, Kiziloren, Tevfik, Kors, Jan A., Koyama, Naoki, Kreuchwig, Annika, Leach, Andrew R., Mayer, Miguel Angel, Monecke, Peter, Muster, Wolfgang, Nakazawa, Chihiro Miyamoto, Nicholson, Gavin, Parry, Rowan, Pastor, Manuel, Piñero, Janet, Oberhauser, Nils, Ramírez-Anguita, Juan Manuel, Rodrigo, Adrián, Smajic, Aljosa, Schaefer, Markus, Schieferdecker, Sebastian, Soininen, Inari, Terricabras, Emma, Trairatphisan, Panuwat, Turner, Sean C., Valencia, Alfonso, van de Water, Bob, van der Lei, Johan L., van Mulligen, Erik M., Vock, Esther, Wilkinson, David, Sanz, Ferran, Pognan, François, Steger-Hartmann, Thomas, Díaz, Carlos, Asakura, Shoji, Amberg, Alexander, Bécourt-Lhote, Nathalie, Blomberg, Niklas, Bosc, Nicolas, Briggs, Katharine, Bringezu, Frank, Brulle-Wohlhueter, Claire, Brunak, Søren, Bueters, Ruud, Callegaro, Giulia, Capella-Gutierrez, Salvador, Centeno, Emilio, Corvi, Javier, Cronin, Mark T.D., Drew, Philip, Duchateau-Nguyen, Guillemette, Ecker, Gerhard F., Escher, Sylvia, Felix, Eloy, Ferreiro, Miguel, Frericks, Markus, Furlong, Laura I., Geiger, Robert, George, Catherine, Grandits, Melanie, Ivanov-Draganov, Dragomir, Kilgour-Christie, Jean, Kiziloren, Tevfik, Kors, Jan A., Koyama, Naoki, Kreuchwig, Annika, Leach, Andrew R., Mayer, Miguel Angel, Monecke, Peter, Muster, Wolfgang, Nakazawa, Chihiro Miyamoto, Nicholson, Gavin, Parry, Rowan, Pastor, Manuel, Piñero, Janet, Oberhauser, Nils, Ramírez-Anguita, Juan Manuel, Rodrigo, Adrián, Smajic, Aljosa, Schaefer, Markus, Schieferdecker, Sebastian, Soininen, Inari, Terricabras, Emma, Trairatphisan, Panuwat, Turner, Sean C., Valencia, Alfonso, van de Water, Bob, van der Lei, Johan L., van Mulligen, Erik M., Vock, Esther, and Wilkinson, David

Published
2023

23. Alloantigen expression on non-hematopoietic cells reduces graft-versus-leukemia effects in mice

Author

Asakura, Shoji, Hashimoto, Daigo, Takashima, Shuichiro, Sugiyama, Haruko, Maeda, Yoshinobu, Akashi, Koichi, Tanimoto, Mitsune, and Teshima, Takanori

Subjects
T cells -- Health aspects -- Research, Graft versus host reaction -- Risk factors -- Care and treatment -- Research, Hematopoietic stem cells -- Transplantation, Health care industry
Abstract

Allogeneic hematopoietic stem cell transplantation (HSCT) is used effectively to treat a number of hematological malignancies. Its beneficial effects rely on donor-derived T cell-targeted leukemic cells, the so-called graft-versus-leukemia (GVL) effect. Induction of GVL is usually associated with concomitant development of graft-versus-host disease (GVHD), a major complication of allogeneic HSCT. The T cells that mediate GVL and GVHD are activated by alloantigen presented on host antigen-presenting cells of hematopoietic origin, and it is not well understood how alloantigen expression on non-hematopoietic cells affects GVL activity. Here we show, in mouse models of MHC-matched, minor histocompatibility antigen-mismatched bone marrow transplantation, that alloantigen expression on host epithelium drives donor T cells into apoptosis and dysfunction during GVHD, resulting in a loss of GVL activity. During GVHD, programmed death-1 (PD-1) and PD ligand-1 (PD-L1), molecules implicated in inducing T cell exhaustion, were upregulated on activated T cells and the target tissue, respectively, suggesting that the T cell defects driven by host epithelial alloantigen expression might be mediated by the PD-1/PD-L1 pathway. Consistent with this, blockade of PD-1/PD-L1 interactions partially restored T cell effector functions and improved GVL. These results elucidate a previously unrecognized significance of alloantigen expression on non-hematopoietic cells in GVL and suggest that separation of GVL from GVHD for more effective HSCT maybe possible in human patients., Introduction Donor immunity in allogeneic hematopoietic stem cell transplantation (HSCT) harnesses beneficial graft-versus-leukemia (GVL) effects; therefore, allogeneic HSCT represents a very potent form of immunotherapy for hematological malignancies (1), (2). [...]

Published
2010
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25. Use of micafungin versus fluconazole for antifungal prophylaxis in neutropenic patients receiving hematopoietic stem cell transplantation

Author

Hiramatsu, Yasushi, Maeda, Yoshinobu, Fujii, Nobuharu, Saito, Takashi, Nawa, Yuichiro, Hara, Masamichi, Yano, Tomofumi, Asakura, Shoji, Sunami, Kazutaka, Tabayashi, Takayuki, Miyata, Akira, Matsuoka, Ken-ichi, Shinagawa, Katsuji, Ikeda, Kazuma, Matsuo, Keitaro, Tanimoto, Mitsune, and for the West-Japan Hematology and Oncology Group (West-JHOG)

Published
2008
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30. Blood and Lung Concentrations of Itraconazole and its Active Metabolite in Patients with Pulmonary Aspergillosis

Author

Matsumoto, Kana, Nakamura, Yaeko, Sato, Atsuo, Asakura, Shoji, and Morita, Kunihiko

Subjects
pulmonary aspergillosis, generic drug, hydroxy-itraconazole, pharmacokinetics, itraconazole
Abstract

A patient was given generic itraconazole (ITCZ) tablet, brand-name-ITCZ capsule, ITCZ oral solution and ITCZ injection to treat pulmonary aspergillosis. We monitored concentrations of ITCZ and its active metabolite hydroxy-ITCZ (OH-ITCZ) in plasma and lung tissues. During administration of the generic product (400 mg/day), trough plasma concentrations of ITCZ and OH-ITCZ were 76 ng/mL and 126 ng/mL, respectively. After administration of the brand-name product (200 mg/day), they increased to 229 ng/mL and 540 ng/mL, respectively. ITCZ and OH-ITCZ concentrations/dosage ratios were 6.1 and 8.4 times higher by switching to the brand-name product, respectively. It was suggested that there may be a difference in pharmacokinetics between the brand-name ITCZ and the generic. Also, we determined ITCZ and OH-ITCZ concentrations infected and uninfected tissues of resected lung simultaneously. The ITCZ concentration in the infected lesion of the lung was approximately 2.3 times higher than that in plasma and 1.6 times higher than in uninfected lung tissue. The OH-ITCZ concentration in the infected lesion was higher than ITCZ in the same region. It was considered that the high concentrations of ITCZ and its metabolite at infected lesion were due to their high affinities with ergosterol in fungal membrane., 研究ノート

Published
2017

41. Disposition and Metabolism of [14C]Lemborexant in Healthy Human Subjects and Characterization of Its Circulating Metabolites▪

Author

Ueno, Takashi, Ishida, Tomomi, Aluri, Jagadeesh, Suzuki, Michiyuki, Beuckmann, Carsten T., Kameyama, Takaaki, Asakura, Shoji, and Kusano, Kazutomi

Abstract

Lemborexant is a novel dual orexin receptor antagonist recently approved for the treatment of insomnia in the United States and Japan. Here, disposition and metabolic profiles were investigated in healthy human subjects. After single oral administration of 10 mg [14C]lemborexant (100 µCi), plasma concentrations of lemborexant and radioactivity peaked at 1 hour postdose and decreased biphasically. Cumulative recovery of the administered radioactivity within 480 hours was 86.5% of the dose, with 29.1% in urine and 57.4% in feces. Unchanged lemborexant was not detected in urine but accounted for 13.0% of the dose in feces, suggesting that the main elimination pathway of lemborexant was metabolism. Metabolite analyses revealed that the major metabolic pathways of lemborexant are oxidation of the dimethylpyrimidine moiety and subsequent further oxidation and/or glucuronidation. In plasma, lemborexant was the dominant component, accounting for 26.5% of total drug-related exposure. M4, M9, M10, and M18 were detected as the major radioactive components; M10 was the only metabolite exceeding 10% of total drug-related exposure. Although M4, M9, and M10 showed binding affinity for orexin receptors comparable to that of lemborexant, their contributions to the sleep-promoting effects of lemborexant are likely low because of the limited brain penetration by P-glycoprotein. Exposure comparison between humans and nonclinical toxicology species confirmed that plasma exposure of M10 was higher in at least one animal species compared with that in humans, indicating that there is no disproportionate metabolite in humans, as defined by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use M3(R2) and U.S. Food and Drug Administration Metabolite in Safety Testing guidance; therefore, no additional toxicology studies are needed.

Published
2021
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42. Agnogenic myeloid metaplasia with extramedullary hematopoiesis and fibrosis in the lung: report of two cases

Author

Asakura, Shoji and Colby, Thomas V.

Subjects
Hematopoiesis -- Physiological aspects -- Case studies, Pulmonary fibrosis -- Physiological aspects -- Case studies, Myelofibrosis -- Case studies -- Physiological aspects, Health, Physiological aspects, Case studies
Abstract

Agnogenic myeloid metaplasia (AMM) is a chronic hematologic disorder with a long clinical course, characteristically accompanied by extramedullary hematopoiesis (EMH) in various organs, most commonly the spleen and liver. We [...]

Published
1994

43. Toxicity testing in the 21st century beyond environmental chemicals

Author

Rovida, Costanza, Asakura, Shoji, Daneshian, Mardas, Hofman-Huether, Hana, Leist, Marcel, Meunier, Leo, Reif, David, Rossi, Anna, Schmutz, Markus, Valentin, Jean-Pierre, Zurlo, Joanne, and Hartung, Thomas

Subjects
food ingredients, drugs, Tox21c, safety assessment, ddc:570
Abstract

After the publication of the report titled Toxicity Testing in the 21st Century – A Vision and a Strategy, many initiatives started to foster a major paradigm shift for toxicity testing – from apical endpoints in animal-based tests to mechanistic endpoints through delineation of pathways of toxicity (PoT) in human cell based systems. The US EPA has funded an important project to develop new high throughput technologies based on human cell based in vitro technologies. These methods are currently being incorporated into the chemical risk assessment process. In the pharmaceutical industry, the efficacy and toxicity of new drugs are evaluated during preclinical investigations that include drug metabolism, pharmacokinetics, pharmacodynamics and safety toxicology studies. The results of these studies are analyzed and extrapolated to predict efficacy and potential adverse effects in humans. However, due to the high failure rate of drugs during the clinical phases, a new approach for a more predictive assessment of drugs both in terms of efficacy and adverse effects is getting urgent. The food industry faces the challenge of assessing novel foods and food ingredients for the general population, while using animal safety testing for extrapolation purposes is often of limited relevance. The question is whether the latest paradigm shift proposed by the Tox21c report for chemicals may provide a useful tool to improve the risk assessment approach also for drugs and food ingredients. published

Published
2015

44. Rapidly Progressed Primary Intestinal Follicular Lymphoma with Elevation of Soluble Interleukin-2 Receptor Levels

Author

Iwamuro, Masaya, Takenaka, Ryuta, Mori, Atsushi, Fujiki, Shigeatsu, Miyake, Takayoshi, Asakura, Shoji, Okada, Hiroyuki, Takata, Katsuyoshi, Yoshino, Tadashi, and Yamamoto, Kazuhide

Subjects
Article Subject, immune system diseases, hemic and lymphatic diseases
Abstract

A 62-year-old Japanese male was diagnosed with primary intestinal follicular lymphoma involving the duodenum, jejunum, and rectum without lymph node involvement. The patient was classified as low risk by the follicular lymphoma international prognostic index (FLIPI) system. Treatment was deferred because he had no symptoms. Eleven months after the diagnosis, his soluble interleukin-2 receptor (sIL-2R) levels had risen from 383 to 617 U/mL. Lymphoma progression involving an enlarged perigastric lymph node was also documented. This report illustrates a case of rapidly progressed intestinal follicular lymphoma, suggesting the possible usefulness of sIL-2R levels as an indicator of lymphoma progression.

Published
2014
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