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Safety, pharmacokinetics, and pharmacodynamics of oral omaveloxolone (RTA 408), a synthetic triterpenoid, in a first-in-human trial of patients with advanced solid tumors.

OncoTargets and therapy

Creelan BC, Gabrilovich DI, Gray JE, Williams CC, Tanvetyanon T, Haura EB, Weber JS, Gibney GT, Markowitz J, Proksch JW, Reisman SA, McKee MD, Chin MP, Meyer CJ, Antonia SJ.
PMID: 28919776
Onco Targets Ther. 2017 Aug 29;10:4239-4250. doi: 10.2147/OTT.S136992. eCollection 2017.

BACKGROUND: Omaveloxolone is a semisynthetic oleanane triterpenoid that potently activates Nrf2 with subsequent antioxidant function. We conducted a first-in-human Phase I clinical trial (NCT02029729) with the primary objectives to determine the appropriate dose for Phase II studies, characterize pharmacokinetic...

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Creelan BC, Gabrilovich DI, Gray JE, et al. Safety, pharmacokinetics, and pharmacodynamics of oral omaveloxolone (RTA 408), a synthetic triterpenoid, in a first-in-human trial of patients with advanced solid tumors. Onco Targets Ther. 2017;10:4239-4250doi: 10.2147/OTT.S136992.
Creelan, B. C., Gabrilovich, D. I., Gray, J. E., Williams, C. C., Tanvetyanon, T., Haura, E. B., Weber, J. S., Gibney, G. T., Markowitz, J., Proksch, J. W., Reisman, S. A., McKee, M. D., Chin, M. P., Meyer, C. J., & Antonia, S. J. (2017). Safety, pharmacokinetics, and pharmacodynamics of oral omaveloxolone (RTA 408), a synthetic triterpenoid, in a first-in-human trial of patients with advanced solid tumors. OncoTargets and therapy, 104239-4250. https://doi.org/10.2147/OTT.S136992
Creelan, Ben C, et al. "Safety, pharmacokinetics, and pharmacodynamics of oral omaveloxolone (RTA 408), a synthetic triterpenoid, in a first-in-human trial of patients with advanced solid tumors." OncoTargets and therapy vol. 10 (2017): 4239-4250. doi: https://doi.org/10.2147/OTT.S136992
Creelan BC, Gabrilovich DI, Gray JE, Williams CC, Tanvetyanon T, Haura EB, Weber JS, Gibney GT, Markowitz J, Proksch JW, Reisman SA, McKee MD, Chin MP, Meyer CJ, Antonia SJ. Safety, pharmacokinetics, and pharmacodynamics of oral omaveloxolone (RTA 408), a synthetic triterpenoid, in a first-in-human trial of patients with advanced solid tumors. Onco Targets Ther. 2017 Aug 29;10:4239-4250. doi: 10.2147/OTT.S136992. eCollection 2017. PMID: 28919776; PMCID: PMC5587199.
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Clinical Cohort Analysis of Germline .

JCO precision oncology

Berry DK, Wang X, Michalski ST, Kang HC, Yang S, Creelan BC, McLeod HL, Hicks JK.
PMID: 34164592
JCO Precis Oncol. 2020 Mar 06;4. doi: 10.1200/PO.19.00297. eCollection 2020 Mar.

No abstract available.

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Berry DK, Wang X, Michalski ST, et al. Clinical Cohort Analysis of Germline . JCO Precis Oncol. 2020;4doi: 10.1200/PO.19.00297.
Berry, D. K., Wang, X., Michalski, S. T., Kang, H. C., Yang, S., Creelan, B. C., McLeod, H. L., & Hicks, J. K. (2020). Clinical Cohort Analysis of Germline . JCO precision oncology, 4. https://doi.org/10.1200/PO.19.00297
Berry, Darcy K, et al. "Clinical Cohort Analysis of Germline ." JCO precision oncology vol. 4 (2020). doi: https://doi.org/10.1200/PO.19.00297
Berry DK, Wang X, Michalski ST, Kang HC, Yang S, Creelan BC, McLeod HL, Hicks JK. Clinical Cohort Analysis of Germline . JCO Precis Oncol. 2020 Mar 06;4. doi: 10.1200/PO.19.00297. eCollection 2020 Mar. PMID: 34164592; PMCID: PMC8216676.
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Manufacturing readiness assessment for evaluation of the microneedle array patch industry: an exploration of barriers to full-scale manufacturing.

Drug delivery and translational research

Creelman B, Frivold C, Jessup S, Saxon G, Jarrahian C.
PMID: 34655041
Drug Deliv Transl Res. 2021 Oct 15; doi: 10.1007/s13346-021-01076-4. Epub 2021 Oct 15.

Microneedle array patch (MAP) technology is a promising new delivery technology for vaccines and pharmaceuticals, yet due to several differing and novel production methods, barriers to full-scale manufacturing exist. PATH conducted a manufacturing readiness assessment and follow-up interviews to...

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Creelman B, Frivold C, Jessup S, et al. Manufacturing readiness assessment for evaluation of the microneedle array patch industry: an exploration of barriers to full-scale manufacturing. Drug Deliv Transl Res. 2021;doi: 10.1007/s13346-021-01076-4.
Creelman, B., Frivold, C., Jessup, S., Saxon, G., & Jarrahian, C. (2021). Manufacturing readiness assessment for evaluation of the microneedle array patch industry: an exploration of barriers to full-scale manufacturing. Drug delivery and translational research, . https://doi.org/10.1007/s13346-021-01076-4
Creelman, Ben, et al. "Manufacturing readiness assessment for evaluation of the microneedle array patch industry: an exploration of barriers to full-scale manufacturing." Drug delivery and translational research vol. (2021). doi: https://doi.org/10.1007/s13346-021-01076-4
Creelman B, Frivold C, Jessup S, Saxon G, Jarrahian C. Manufacturing readiness assessment for evaluation of the microneedle array patch industry: an exploration of barriers to full-scale manufacturing. Drug Deliv Transl Res. 2021 Oct 15; doi: 10.1007/s13346-021-01076-4. Epub 2021 Oct 15. PMID: 34655041.
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Characterization of a Reservoir-Style Implant for Sustained Release of Tenofovir Alafenamide (TAF) for HIV Pre-Exposure Prophylaxis (PrEP).

Pharmaceutics

Johnson LM, Krovi SA, Li L, Girouard N, Demkovich ZR, Myers D, Creelman B, van der Straten A.
PMID: 31277461
Pharmaceutics. 2019 Jul 04;11(7). doi: 10.3390/pharmaceutics11070315.

Long-acting (LA) HIV pre-exposure prophylaxis (PrEP) offers the potential to improve adherence by lowering the burden of daily or on-demand regimens of antiretroviral (ARV) drugs. This paper details the fabrication and in vitro performance of a subcutaneous and trocar-compatible...

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Johnson LM, Krovi SA, Li L, et al. Characterization of a Reservoir-Style Implant for Sustained Release of Tenofovir Alafenamide (TAF) for HIV Pre-Exposure Prophylaxis (PrEP). Pharmaceutics. 2019;11(7)doi: 10.3390/pharmaceutics11070315.
Johnson, L. M., Krovi, S. A., Li, L., Girouard, N., Demkovich, Z. R., Myers, D., Creelman, B., & van der Straten, A. (2019). Characterization of a Reservoir-Style Implant for Sustained Release of Tenofovir Alafenamide (TAF) for HIV Pre-Exposure Prophylaxis (PrEP). Pharmaceutics, 11(7), . https://doi.org/10.3390/pharmaceutics11070315
Johnson, Leah M, et al. "Characterization of a Reservoir-Style Implant for Sustained Release of Tenofovir Alafenamide (TAF) for HIV Pre-Exposure Prophylaxis (PrEP)." Pharmaceutics vol. 11,7 (2019). doi: https://doi.org/10.3390/pharmaceutics11070315
Johnson LM, Krovi SA, Li L, Girouard N, Demkovich ZR, Myers D, Creelman B, van der Straten A. Characterization of a Reservoir-Style Implant for Sustained Release of Tenofovir Alafenamide (TAF) for HIV Pre-Exposure Prophylaxis (PrEP). Pharmaceutics. 2019 Jul 04;11(7). doi: 10.3390/pharmaceutics11070315. PMID: 31277461; PMCID: PMC6680758.
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Correction: Transforming growth factor β-induced epithelial-to-mesenchymal signature predicts metastasis-free survival in non-small cell lung cancer.

Oncotarget

Gordian E, Welsh EA, Gimbrone N, Siegel EM, Shibata D, Creelan BC, Cress WD, Eschrich SA, Haura EB, Muñoz-Antonia T.
PMID: 34194632
Oncotarget. 2021 Jun 22;12(13):1325. doi: 10.18632/oncotarget.28004. eCollection 2021 Jun 22.

[This corrects the article DOI: 10.18632/oncotarget.26574.].

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Gordian E, Welsh EA, Gimbrone N, et al. Correction: Transforming growth factor β-induced epithelial-to-mesenchymal signature predicts metastasis-free survival in non-small cell lung cancer. Oncotarget. 2021;12(13):1325doi: 10.18632/oncotarget.28004.
Gordian, E., Welsh, E. A., Gimbrone, N., Siegel, E. M., Shibata, D., Creelan, B. C., Cress, W. D., Eschrich, S. A., Haura, E. B., & Muñoz-Antonia, T. (2021). Correction: Transforming growth factor β-induced epithelial-to-mesenchymal signature predicts metastasis-free survival in non-small cell lung cancer. Oncotarget, 12(13), 1325. https://doi.org/10.18632/oncotarget.28004
Gordian, Edna, et al. "Correction: Transforming growth factor β-induced epithelial-to-mesenchymal signature predicts metastasis-free survival in non-small cell lung cancer." Oncotarget vol. 12,13 (2021): 1325. doi: https://doi.org/10.18632/oncotarget.28004
Gordian E, Welsh EA, Gimbrone N, Siegel EM, Shibata D, Creelan BC, Cress WD, Eschrich SA, Haura EB, Muñoz-Antonia T. Correction: Transforming growth factor β-induced epithelial-to-mesenchymal signature predicts metastasis-free survival in non-small cell lung cancer. Oncotarget. 2021 Jun 22;12(13):1325. doi: 10.18632/oncotarget.28004. eCollection 2021 Jun 22. PMID: 34194632; PMCID: PMC8238243.
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Transforming growth factor β-induced epithelial-to-mesenchymal signature predicts metastasis-free survival in non-small cell lung cancer.

Oncotarget

Gordian E, Welsh EA, Gimbrone N, Siegel EM, Shibata D, Creelan BC, Cress WD, Eschrich SA, Haura EB, Muñoz-Antonia T.
PMID: 30783512
Oncotarget. 2019 Jan 25;10(8):810-824. doi: 10.18632/oncotarget.26574. eCollection 2019 Jan 25.

Transforming growth factor beta (TGFβ) plays a key role in regulating epithelial-to-mesenchymal transition (EMT). A gene expression signature (

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Gordian E, Welsh EA, Gimbrone N, et al. Transforming growth factor β-induced epithelial-to-mesenchymal signature predicts metastasis-free survival in non-small cell lung cancer. Oncotarget. 2019;10(8):810-824doi: 10.18632/oncotarget.26574.
Gordian, E., Welsh, E. A., Gimbrone, N., Siegel, E. M., Shibata, D., Creelan, B. C., Cress, W. D., Eschrich, S. A., Haura, E. B., & Muñoz-Antonia, T. (2019). Transforming growth factor β-induced epithelial-to-mesenchymal signature predicts metastasis-free survival in non-small cell lung cancer. Oncotarget, 10(8), 810-824. https://doi.org/10.18632/oncotarget.26574
Gordian, Edna, et al. "Transforming growth factor β-induced epithelial-to-mesenchymal signature predicts metastasis-free survival in non-small cell lung cancer." Oncotarget vol. 10,8 (2019): 810-824. doi: https://doi.org/10.18632/oncotarget.26574
Gordian E, Welsh EA, Gimbrone N, Siegel EM, Shibata D, Creelan BC, Cress WD, Eschrich SA, Haura EB, Muñoz-Antonia T. Transforming growth factor β-induced epithelial-to-mesenchymal signature predicts metastasis-free survival in non-small cell lung cancer. Oncotarget. 2019 Jan 25;10(8):810-824. doi: 10.18632/oncotarget.26574. eCollection 2019 Jan 25. PMID: 30783512; PMCID: PMC6368226.
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Manufacturing readiness assessment for evaluation of the microneedle array patch industry: an exploration of barriers to full-scale manufacturing.

Drug delivery and translational research

Creelman B, Frivold C, Jessup S, Saxon G, Jarrahian C.
PMID: 34655041
Drug Deliv Transl Res. 2022 Feb;12(2):368-375. doi: 10.1007/s13346-021-01076-4. Epub 2021 Oct 15.

Microneedle array patch (MAP) technology is a promising new delivery technology for vaccines and pharmaceuticals, yet due to several differing and novel production methods, barriers to full-scale manufacturing exist. PATH conducted a manufacturing readiness assessment and follow-up interviews to...

Cite
Creelman B, Frivold C, Jessup S, et al. Manufacturing readiness assessment for evaluation of the microneedle array patch industry: an exploration of barriers to full-scale manufacturing. Drug Deliv Transl Res. 2021;12(2):368-375doi: 10.1007/s13346-021-01076-4.
Creelman, B., Frivold, C., Jessup, S., Saxon, G., & Jarrahian, C. (2022). Manufacturing readiness assessment for evaluation of the microneedle array patch industry: an exploration of barriers to full-scale manufacturing. Drug delivery and translational research, 12(2), 368-375. https://doi.org/10.1007/s13346-021-01076-4
Creelman, Ben, et al. "Manufacturing readiness assessment for evaluation of the microneedle array patch industry: an exploration of barriers to full-scale manufacturing." Drug delivery and translational research vol. 12,2 (2022): 368-375. doi: https://doi.org/10.1007/s13346-021-01076-4
Creelman B, Frivold C, Jessup S, Saxon G, Jarrahian C. Manufacturing readiness assessment for evaluation of the microneedle array patch industry: an exploration of barriers to full-scale manufacturing. Drug Deliv Transl Res. 2022 Feb;12(2):368-375. doi: 10.1007/s13346-021-01076-4. Epub 2021 Oct 15. PMID: 34655041; PMCID: PMC8724218.
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Manufacturing readiness assessment for evaluation of the microneedle array patch industry: an exploration of barriers to full-scale manufacturing.

Drug delivery and translational research

Creelman B, Frivold C, Jessup S, Saxon G, Jarrahian C.
PMID: 34655041
Drug Deliv Transl Res. 2022 Feb;12(2):368-375. doi: 10.1007/s13346-021-01076-4. Epub 2021 Oct 15.

Microneedle array patch (MAP) technology is a promising new delivery technology for vaccines and pharmaceuticals, yet due to several differing and novel production methods, barriers to full-scale manufacturing exist. PATH conducted a manufacturing readiness assessment and follow-up interviews to...

Cite
Creelman B, Frivold C, Jessup S, et al. Manufacturing readiness assessment for evaluation of the microneedle array patch industry: an exploration of barriers to full-scale manufacturing. Drug Deliv Transl Res. 2021;12(2):368-375doi: 10.1007/s13346-021-01076-4.
Creelman, B., Frivold, C., Jessup, S., Saxon, G., & Jarrahian, C. (2022). Manufacturing readiness assessment for evaluation of the microneedle array patch industry: an exploration of barriers to full-scale manufacturing. Drug delivery and translational research, 12(2), 368-375. https://doi.org/10.1007/s13346-021-01076-4
Creelman, Ben, et al. "Manufacturing readiness assessment for evaluation of the microneedle array patch industry: an exploration of barriers to full-scale manufacturing." Drug delivery and translational research vol. 12,2 (2022): 368-375. doi: https://doi.org/10.1007/s13346-021-01076-4
Creelman B, Frivold C, Jessup S, Saxon G, Jarrahian C. Manufacturing readiness assessment for evaluation of the microneedle array patch industry: an exploration of barriers to full-scale manufacturing. Drug Deliv Transl Res. 2022 Feb;12(2):368-375. doi: 10.1007/s13346-021-01076-4. Epub 2021 Oct 15. PMID: 34655041.
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Molecular cloning of an attenuated chicken anaemia virus isolate following repeated cell culture passage.

Avian pathology : journal of the W.V.P.A

Todd D, Connor TJ, Calvert VM, Creelan JL, Meehan BM, McNulty MS.
PMID: 18645774
Avian Pathol. 1995 Mar;24(1):171-87. doi: 10.1080/03079459508419057.

The pathogenicity of the Cux-1 isolate of chicken anaemia virus (CAV) was substantially reduced following large numbers (50 to 173) of passages in MDCC-MSBl cells. Restriction endonuclease analysis of polymerase chain reaction (PCR)- amplified DNAs and recombinant plasmids containing...

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Todd D, Connor TJ, Calvert VM, et al. Molecular cloning of an attenuated chicken anaemia virus isolate following repeated cell culture passage. Avian Pathol. 1995;24(1):171-87doi: 10.1080/03079459508419057.
Todd, D., Connor, T. J., Calvert, V. M., Creelan, J. L., Meehan, B. M., & McNulty, M. S. (1995). Molecular cloning of an attenuated chicken anaemia virus isolate following repeated cell culture passage. Avian pathology : journal of the W.V.P.A, 24(1), 171-87. https://doi.org/10.1080/03079459508419057
Todd, D, et al. "Molecular cloning of an attenuated chicken anaemia virus isolate following repeated cell culture passage." Avian pathology : journal of the W.V.P.A vol. 24,1 (1995): 171-87. doi: https://doi.org/10.1080/03079459508419057
Todd D, Connor TJ, Calvert VM, Creelan JL, Meehan BM, McNulty MS. Molecular cloning of an attenuated chicken anaemia virus isolate following repeated cell culture passage. Avian Pathol. 1995 Mar;24(1):171-87. doi: 10.1080/03079459508419057. PMID: 18645774.
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Effect of multiple cell culture passages on the biological behaviour of chicken anaemia virus.

Avian pathology : journal of the W.V.P.A

Todd D, Connor TJ, Creelan JL, Borghmans BJ, Calvert VM, McNulty MS.
PMID: 18483967
Avian Pathol. 1998;27(1):74-9. doi: 10.1080/03079459808419277.

The Cux-1 isolate of chicken anaemia virus (CAV) was passaged over 320 times in Marek's disease virus transformed chicken lymphoblastoid (MDCC-MSB1) cells. Comparison of the infectivity titres of virus pools derived from viruses that had received 0 (P0), 49...

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Todd D, Connor TJ, Creelan JL, et al. Effect of multiple cell culture passages on the biological behaviour of chicken anaemia virus. Avian Pathol. 1998;27(1):74-9doi: 10.1080/03079459808419277.
Todd, D., Connor, T. J., Creelan, J. L., Borghmans, B. J., Calvert, V. M., & McNulty, M. S. (1998). Effect of multiple cell culture passages on the biological behaviour of chicken anaemia virus. Avian pathology : journal of the W.V.P.A, 27(1), 74-9. https://doi.org/10.1080/03079459808419277
Todd, D, et al. "Effect of multiple cell culture passages on the biological behaviour of chicken anaemia virus." Avian pathology : journal of the W.V.P.A vol. 27,1 (1998): 74-9. doi: https://doi.org/10.1080/03079459808419277
Todd D, Connor TJ, Creelan JL, Borghmans BJ, Calvert VM, McNulty MS. Effect of multiple cell culture passages on the biological behaviour of chicken anaemia virus. Avian Pathol. 1998;27(1):74-9. doi: 10.1080/03079459808419277. PMID: 18483967.
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Educators have hard choices; nationally, not just in kansas.

Science (New York, N.Y.)

White A, Meier W, Lovell F, McCoy W, Robinove CJ, Creelan TF, Brun R, Gordon I, West RM, Collier IE, Gish DT, Hartmann WK, Behe MJ, Scott EC.
PMID: 17839152
Science. 2000 Aug 11;289(5481):869d-71d. doi: 10.1126/science.289.5481.869d.

No abstract available.

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White A, Meier W, Lovell F, et al. Educators have hard choices; nationally, not just in kansas. Science. 2000;289(5481):869d-71ddoi: 10.1126/science.289.5481.869d.
White, A., Meier, W., Lovell, F., McCoy, W., Robinove, C. J., Creelan, T. F., Brun, R., Gordon, I., West, R. M., Collier, I. E., Gish, D. T., Hartmann, W. K., Behe, M. J., & Scott, E. C. (2000). Educators have hard choices; nationally, not just in kansas. Science (New York, N.Y.), 289(5481), 869d-71d. https://doi.org/10.1126/science.289.5481.869d
White, A, et al. "Educators have hard choices; nationally, not just in kansas." Science (New York, N.Y.) vol. 289,5481 (2000): 869d-71d. doi: https://doi.org/10.1126/science.289.5481.869d
White A, Meier W, Lovell F, McCoy W, Robinove CJ, Creelan TF, Brun R, Gordon I, West RM, Collier IE, Gish DT, Hartmann WK, Behe MJ, Scott EC. Educators have hard choices; nationally, not just in kansas. Science. 2000 Aug 11;289(5481):869d-71d. doi: 10.1126/science.289.5481.869d. PMID: 17839152.
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Genome Organization and Dynamics Specialty Grand Challenge.

Frontiers in molecular biosciences

Freeman BC.
PMID: 35036413
Front Mol Biosci. 2021 Dec 31;8:818707. doi: 10.3389/fmolb.2021.818707. eCollection 2021.

No abstract available.

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Freeman BC. Genome Organization and Dynamics Specialty Grand Challenge. Front Mol Biosci. 2021;8:818707doi: 10.3389/fmolb.2021.818707.
Freeman, B. C. (2021). Genome Organization and Dynamics Specialty Grand Challenge. Frontiers in molecular biosciences, 8818707. https://doi.org/10.3389/fmolb.2021.818707
Freeman, Brian Christopher. "Genome Organization and Dynamics Specialty Grand Challenge." Frontiers in molecular biosciences vol. 8 (2021): 818707. doi: https://doi.org/10.3389/fmolb.2021.818707
Freeman BC. Genome Organization and Dynamics Specialty Grand Challenge. Front Mol Biosci. 2021 Dec 31;8:818707. doi: 10.3389/fmolb.2021.818707. eCollection 2021. PMID: 35036413; PMCID: PMC8758561.
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