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Article ; Online: Identifying a stable bulk dmLT adjuvant formulation at a clinically relevant concentration.

Estrada, Marcus R / Bzami, Anan / Norton, Elizabeth B / White, Jessica A

2023 Volume 41, Issue 7, Page(s) 1362–1367

Abstract: Double mutant heat-labile toxin (dmLT) is a novel vaccine adjuvant under development with several different vaccine candidates. Studies using existing dmLT adjuvant stocks require significant dilution to achieve a clinically relevant dose. This dilution ... ...

Abstract	Double mutant heat-labile toxin (dmLT) is a novel vaccine adjuvant under development with several different vaccine candidates. Studies using existing dmLT adjuvant stocks require significant dilution to achieve a clinically relevant dose. This dilution leads to wastage of the adjuvant. This manuscript describes a limited formulation study to improve the stability of bulk dmLT at a more clinically relevant concentration (20 µg/mL) with minimal changes to the existing bulk dmLT formulation. In vitro methods were used to evaluate dmLT stability after lyophilization and short-term accelerated stability studies. The addition of the excipient polysorbate 80 (PS80) at 0.05 % to the existing dmLT formulation was identified as the lead modification that provided improved stability of the lyophilized dmLT at 20 µg/mL through 4 weeks at 40 °C.
MeSH term(s)	Bacterial Toxins ; Enterotoxins ; Hot Temperature ; Escherichia coli Proteins ; Adjuvants, Immunologic
Chemical Substances	Bacterial Toxins ; Enterotoxins ; Escherichia coli Proteins ; Adjuvants, Immunologic
Language	English
Publishing date	2023-01-17
Publishing country	Netherlands
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2023.01.005
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Article ; Online: Identifying a stable bulk dmLT adjuvant formulation at a clinically relevant concentration

Estrada, Marcus R. / Bzami, Anan / Norton, Elizabeth B. / White, Jessica A.

Vaccine. 2023 Feb., v. 41, no. 7 p.1362-1367

2023

Abstract	Double mutant heat-labile toxin (dmLT) is a novel vaccine adjuvant under development with several different vaccine candidates. Studies using existing dmLT adjuvant stocks require significant dilution to achieve a clinically relevant dose. This dilution leads to wastage of the adjuvant. This manuscript describes a limited formulation study to improve the stability of bulk dmLT at a more clinically relevant concentration (20 µg/mL) with minimal changes to the existing bulk dmLT formulation. In vitro methods were used to evaluate dmLT stability after lyophilization and short-term accelerated stability studies. The addition of the excipient polysorbate 80 (PS80) at 0.05 % to the existing dmLT formulation was identified as the lead modification that provided improved stability of the lyophilized dmLT at 20 µg/mL through 4 weeks at 40 °C.
Keywords	freeze drying ; lead ; mutants ; polysorbates ; toxins ; vaccine adjuvants ; vaccines ; dmLT ; Adjuvant ; Formulation ; E.coli heat-labile toxin
Language	English
Dates of publication	2023-02
Size	p. 1362-1367.
Publishing place	Elsevier Ltd
Document type	Article ; Online
Note	Use and reproduction
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2023.01.005
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Article ; Online: Tolerability of ifosfamide-containing regimen in patients with high-risk renal and INI-1-deficient tumors.

Wong, Chris I / Benedetti, Daniel J / Kao, Pei-Chi / Ma, Clement / Marcus, Karen J / Mullen, Elizabeth A

Pediatric blood & cancer

2023 Volume 70, Issue 8, Page(s) e30422

Abstract: Background: Outcomes for children with high-risk renal (HRR) and INI-1-deficient (INI-) tumors are unacceptably poor. Concerns about excessive toxicity-as many are infants and/or undergo nephrectomy-have resulted in decreased chemotherapy dosing and ... ...

Abstract	Background: Outcomes for children with high-risk renal (HRR) and INI-1-deficient (INI-) tumors are unacceptably poor. Concerns about excessive toxicity-as many are infants and/or undergo nephrectomy-have resulted in decreased chemotherapy dosing and omission of the nephrotoxic drug ifosfamide in collaborative group studies. As cause of death for children with these cancers remains overwhelmingly more from progressive disease rather than treatment toxicity, we examined the tolerability of an intensive ifosfamide-containing regimen. Procedure: Retrospective review of children with HRR/INI- tumors treated at a single institution with vincristine, doxorubicin, cyclophosphamide alternating with ifosfamide, carboplatin, etoposide (VDC-ICE) from 2006-2016. The primary outcome was regimen tolerability, including kidney injury and grade 3-5 nonhematologic toxicities. Results: Fourteen patients with a median age of 1.7 years (range: 0.1-10.5) treated with VDC-ICE were identified. Diagnosis included malignant rhabdoid tumor (n = 9) (primary renal [n = 2]); diffuse anaplastic Wilms tumor (n = 3); clear cell sarcoma of the kidney (n = 1); and anaplastic chordoma (n = 1). All children with primary renal tumors (43%) underwent complete (n = 5) or partial nephrectomy (n = 1) before chemotherapy. Nine (64%) completed all intended cycles of chemotherapy; n = 5 (36%) did not due to disease progression. Unplanned hospitalizations occurred in 13 (93%) patients, most commonly for febrile neutropenia. No patient experienced severe organ toxicity, diminished renal function, treatment discontinuation due to toxicities, or treatment-related death. Conclusions: In children with HRR/INI- tumors, VDC-ICE chemotherapy was well-tolerated without excessive toxicities, even amongst young patients with solitary kidneys. Concerns about toxicity should not preclude an intensive ifosfamide-containing regimen from use in future trials in this population.
MeSH term(s)	Child ; Infant ; Humans ; Child, Preschool ; Ifosfamide ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Neoplasms/drug therapy ; Cyclophosphamide ; Etoposide ; Carboplatin ; Vincristine ; Kidney/physiology
Chemical Substances	Ifosfamide (UM20QQM95Y) ; Cyclophosphamide (8N3DW7272P) ; Etoposide (6PLQ3CP4P3) ; Carboplatin (BG3F62OND5) ; Vincristine (5J49Q6B70F)
Language	English
Publishing date	2023-05-23
Publishing country	United States
Document type	Journal Article
ZDB-ID	2131448-2
ISSN	1545-5017 ; 1545-5009
ISSN (online)	1545-5017
ISSN	1545-5009
DOI	10.1002/pbc.30422
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Article: Recognition and screening for Chagas disease in the USA.

Marcus, Rachel / Henao-Martínez, Andrés F / Nolan, Melissa / Livingston, Elizabeth / Klotz, Stephen A / Gilman, Robert H / Miranda-Schaeubinger, Monica / Meymandi, Sheba

Therapeutic advances in infectious disease

2021 Volume 8, Page(s) 20499361211046086

Abstract: Chagas disease (CD), caused by the ... ...

Abstract	Chagas disease (CD), caused by the protozoan
Language	English
Publishing date	2021-09-22
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2728410-4
ISSN	2049-937X ; 2049-9361
ISSN (online)	2049-937X
ISSN	2049-9361
DOI	10.1177/20499361211046086
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Article ; Online: Assessing Metabolic Differences Associated with Exposure to Polybrominated Biphenyl and Polychlorinated Biphenyls in the Michigan PBB Registry.

Hoffman, Susan S / Liang, Donghai / Hood, Robert B / Tan, Youran / Terrell, Metrecia L / Marder, M Elizabeth / Barton, Hillary / Pearson, Melanie A / Walker, Douglas I / Barr, Dana Boyd / Jones, Dean P / Marcus, Michele

Environmental health perspectives

2023 Volume 131, Issue 10, Page(s) 107005

Abstract: Background: Polybrominated biphenyls (PBB) and polychlorinated biphenyls (PCB) are persistent organic pollutants with potential endocrine-disrupting effects linked to adverse health outcomes.: Objectives: In this study, we utilize high-resolution ... ...

Abstract	Background: Polybrominated biphenyls (PBB) and polychlorinated biphenyls (PCB) are persistent organic pollutants with potential endocrine-disrupting effects linked to adverse health outcomes. Objectives: In this study, we utilize high-resolution metabolomics (HRM) to identify internal exposure and biological responses underlying PCB and multigenerational PBB exposure for participants enrolled in the Michigan PBB Registry. Methods: HRM profiling was conducted on plasma samples collected from 2013 to 2014 from a subset of participants enrolled in the Michigan PBB Registry, including 369 directly exposed individuals (F0) who were alive when PBB mixtures were accidentally introduced into the food chain and 129 participants exposed to PBB Results: Mean levels were Conclusions: Our results demonstrate that serum PBB-153 is associated with alterations in inflammation and oxidative stress-related pathways, which differed when stratified by generation. We also found that
MeSH term(s)	Female ; Humans ; Polychlorinated Biphenyls/toxicity ; Polybrominated Biphenyls/toxicity ; Michigan ; Registries ; Inflammation
Chemical Substances	Polychlorinated Biphenyls (DFC2HB4I0K) ; 2,4,5,2',4',5'-hexabromobiphenyl (9S2PWX7KBN) ; Polybrominated Biphenyls
Language	English
Publishing date	2023-10-10
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	195189-0
ISSN	1552-9924 ; 0091-6765 ; 1078-0475
ISSN (online)	1552-9924
ISSN	0091-6765 ; 1078-0475
DOI	10.1289/EHP12657
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Zs.MO 379: Show issues

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Article ; Online: Editorial: tegoprazan-the newest advance in the management of acid-related diseases.

Marcus, Elizabeth A / Pisegna, Joseph R

Alimentary pharmacology & therapeutics

2020 Volume 52, Issue 6, Page(s) 1074–1075

MeSH term(s)	Benzene Derivatives ; Humans ; Imidazoles ; Lansoprazole ; Potassium ; Stomach Ulcer
Chemical Substances	Benzene Derivatives ; Imidazoles ; Lansoprazole (0K5C5T2QPG) ; Potassium (RWP5GA015D) ; tegoprazan (W017G7IF4S)
Language	English
Publishing date	2020-10-29
Publishing country	England
Document type	Editorial ; Research Support, N.I.H., Extramural ; Research Support, U.S. Gov't, Non-P.H.S. ; Comment
ZDB-ID	639012-2
ISSN	1365-2036 ; 0269-2813 ; 0953-0673
ISSN (online)	1365-2036
ISSN	0269-2813 ; 0953-0673
DOI	10.1111/apt.15963
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Zs.A 2206: Show issues

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Article ; Online: Bilateral Wilms tumor with anaplasia: A report from the Children's Oncology Group Study AREN0534.

Pediatric blood & cancer

2024 , Page(s) e30981

Abstract: Introduction: The purpose of this study is to examine the outcomes in children with anaplastic bilateral Wilms tumor (BWT) from study AREN0534 in order to define potential prognostic factors and areas to target in future clinical trials.: Methods: ... ...

Abstract	Introduction: The purpose of this study is to examine the outcomes in children with anaplastic bilateral Wilms tumor (BWT) from study AREN0534 in order to define potential prognostic factors and areas to target in future clinical trials. Methods: Demographic and clinical data from AREN0534 study patients with anaplasia (focal anaplasia [FA], or diffuse anaplasia [DA]) were compared. Event-free survival (EFS) and overall survival (OS) were reported using Kaplan-Meier estimation with 95% confidence bands, and differences in outcomes between FA and DA compared using log-rank tests. The impact of margin status was analyzed. Results: Twenty-seven children who enrolled on AREN0534 had evidence of anaplasia (17 DA, 10 FA) in at least one kidney and were included in this analysis. Twenty-six (96%) had BWT. Nineteen percent had anaplastic histology in both kidneys (four of 17 DA, and one of 10 FA). Forty-six percent with BWT had bilateral nephron-sparing surgery (NSS); one child who went off protocol therapy, eventually required bilateral completion nephrectomies. Median follow-up for EFS and OS was 8.6 and 8.7 years from enrollment. Four- and 8-year EFS was 53% [95% confidence interval (CI): 34%-83%] for DA; 4-year EFS was 80% [95% CI: 59%-100%], and 8-year EFS 70% [95% CI: 47%-100%] for FA. Three out of 10 children with FA and eight out of 17 children with DA had events. EFS did not differ statistically by margin status (p = .79; HR = 0.88). Among the six children who died (five DA, one FA), all experienced prior relapse or progression within 18 months. Conclusion: Events in children with DA/FA in the setting of BWT occurred early. Caution should be taken about interpreting the impact of margin status outcomes in the context of contemporary multimodal therapy. Future targeted investigations in children with BWT and DA/FA are needed.
Language	English
Publishing date	2024-04-18
Publishing country	United States
Document type	Journal Article
ZDB-ID	2131448-2
ISSN	1545-5017 ; 1545-5009
ISSN (online)	1545-5017
ISSN	1545-5009
DOI	10.1002/pbc.30981
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Article ; Online: HJV

Vadivelan, Akhila / Zhang, Sarah / Srole, Daniel N / Marcus, Elizabeth A / Neto, George Carvalho / Nemeth, Elizabeta / Ganz, Tomas / De Oliveira, Satiro

Haematologica

2024

Language	English
Publishing date	2024-03-07
Publishing country	Italy
Document type	Journal Article
ZDB-ID	2333-4
ISSN	1592-8721 ; 0017-6567 ; 0390-6078
ISSN (online)	1592-8721
ISSN	0017-6567 ; 0390-6078
DOI	10.3324/haematol.2023.284134
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Article ; Online: Dupilumab in patients with chronic spontaneous urticaria (LIBERTY-CSU CUPID): Two randomized, double-blind, placebo-controlled, phase 3 trials.

Maurer, Marcus / Casale, Thomas B / Saini, Sarbjit S / Ben-Shoshan, Moshe / Giménez-Arnau, Ana M / Bernstein, Jonathan A / Yagami, Akiko / Stjepanovic, Aleksandra / Radin, Allen / Staudinger, Heribert W / Patel, Naimish / Amin, Nikhil / Akinlade, Bolanle / Fan, Chunpeng / Bauer, Deborah / Yancopoulos, George D / Patel, Kiran / Mannent, Leda P / Laws, Elizabeth

The Journal of allergy and clinical immunology

2024

Abstract: Background: Chronic spontaneous urticaria (CSU) is a chronic inflammatory disease characterized by recurrent pruritic wheals (hives) and/or angioedema. Patients with CSU could remain symptomatic despite standard-of-care H: Objective: We conducted two ...

Abstract	Background: Chronic spontaneous urticaria (CSU) is a chronic inflammatory disease characterized by recurrent pruritic wheals (hives) and/or angioedema. Patients with CSU could remain symptomatic despite standard-of-care H Objective: We conducted two phase 3, randomized, placebo-controlled, double-blind trials comparing dupilumab with placebo in patients with symptomatic CSU despite H1-AH. Methods: In LIBERTY-CSU CUPID Study A, patients were omalizumab-naive (n = 138, aged ≥6 years). In Study B, patients were omalizumab-intolerant/incomplete responders (n = 108, aged ≥12 years). The primary end point was either change from baseline over 7 days in the Urticaria Activity Score (UAS7) or Itch Severity Score (ISS7) at week 24, with the other as a key secondary end point, depending on regional regulatory requirements. Studies were pooled for safety assessment. Results: In Study A, UAS7 and ISS7 improved with dupilumab versus placebo (difference -8.5 [95% CI, -13.2 to -3.9; P = .0003] and -4.2 [95% CI, -6.6 to -1.8; P = .0005]). In Study B, tested at α = 0.043 after interim analysis, UAS7 improved (difference -5.8 [95% CI, -11.4 to -0.3; P = .0390]), with a numerical trend in ISS7 (difference -2.9 [95% CI, -5.7 to -0.07; nominal P = .0449, not significant]). Pooled safety data were consistent between dupilumab and placebo and with the known dupilumab safety profile. Conclusions: Dupilumab reduced urticaria activity by reducing itch and hives severity in omalizumab-naive patients with CSU uncontrolled with H1-AH. Although the primary end point for Study B was not met, dupilumab effects were small in patients who were omalizumab-intolerant/incomplete responders.
Language	English
Publishing date	2024-02-29
Publishing country	United States
Document type	Journal Article
ZDB-ID	121011-7
ISSN	1097-6825 ; 1085-8725 ; 0091-6749
ISSN (online)	1097-6825 ; 1085-8725
ISSN	0091-6749
DOI	10.1016/j.jaci.2024.01.028
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Article ; Online: Treatment of an Adolescent Female With Nonalcoholic Steatohepatitis-Related Cirrhosis With Liraglutide.

Yuen, Christina / Yu, Tiffany / French, Samuel / Marcus, Elizabeth A / Yeh, Joanna / Chiu, Harvey

JPGN reports

2023 Volume 4, Issue 2, Page(s) e303

Abstract: Nonalcoholic fatty liver disease is the most common chronic liver disease in children in the United States and encompasses a range of disease from steatosis to cirrhosis. The mainstay of treatment is lifestyle modifications like increased physical ... ...

Abstract	Nonalcoholic fatty liver disease is the most common chronic liver disease in children in the United States and encompasses a range of disease from steatosis to cirrhosis. The mainstay of treatment is lifestyle modifications like increased physical activity and healthier eating habits. These are sometimes augmented with medications or surgery for weight loss. We present a patient with biopsy-proven nonalcoholic steatohepatitis-related cirrhosis that did not improve with suboptimal lifestyle changes. This patient's disease progression reversed after liraglutide treatment, as evidenced by improved imaging and laboratory results, despite no significant improvement in her body mass index percentile. This case demonstrates the importance of considering liraglutide for patients with nonalcoholic steatohepatitis and suggests a hepatic effect independent of effects related to weight loss.
Language	English
Publishing date	2023-03-30
Publishing country	United States
Document type	Case Reports
ISSN	2691-171X
ISSN (online)	2691-171X
DOI	10.1097/PG9.0000000000000303
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