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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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Ameliorative Effects of Chloroform Fraction of Cocos nucifera L. Husk Fiber Against Cisplatin-induced Toxicity in Rats.

Pharmacognosy research

Adaramoye OA, Azeez AF, Ola-Davies OE.
PMID: 27034598
Pharmacognosy Res. 2016 Apr-Jun;8(2):89-96. doi: 10.4103/0974-8490.172658.

BACKGROUND: Cisplatin (Cis) is used in the treatment of solid tumors and is known to elicit serious side effects.OBJECTIVE: The present study investigated the protective effects of chloroform fraction of Cocos nucifera husk fiber (CFCN) against Cis-induced organs' damage...

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Adaramoye OA, Azeez AF, Ola-Davies OE. Ameliorative Effects of Chloroform Fraction of Cocos nucifera L. Husk Fiber Against Cisplatin-induced Toxicity in Rats. Pharmacognosy Res. 2016;8(2):89-96doi: 10.4103/0974-8490.172658.
Adaramoye, O. A., Azeez, A. F., & Ola-Davies, O. E. (2016). Ameliorative Effects of Chloroform Fraction of Cocos nucifera L. Husk Fiber Against Cisplatin-induced Toxicity in Rats. Pharmacognosy research, 8(2), 89-96. https://doi.org/10.4103/0974-8490.172658
Adaramoye, Oluwatosin Adekunle, et al. "Ameliorative Effects of Chloroform Fraction of Cocos nucifera L. Husk Fiber Against Cisplatin-induced Toxicity in Rats." Pharmacognosy research vol. 8,2 (2016): 89-96. doi: https://doi.org/10.4103/0974-8490.172658
Adaramoye OA, Azeez AF, Ola-Davies OE. Ameliorative Effects of Chloroform Fraction of Cocos nucifera L. Husk Fiber Against Cisplatin-induced Toxicity in Rats. Pharmacognosy Res. 2016 Apr-Jun;8(2):89-96. doi: 10.4103/0974-8490.172658. PMID: 27034598; PMCID: PMC4780144.
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Biochemical Markers of Bone Turnover in Patients with β-Thalassemia Major: A Single Center Study from Southern Pakistan.

Advances in hematology

Sultan S, Irfan SM, Ahmed SI.
PMID: 27006658
Adv Hematol. 2016;2016:5437609. doi: 10.1155/2016/5437609. Epub 2016 Feb 23.

Objectives. Skeletal complications in β-homozygous thalassemic patients are uncommon but often debilitating, even amongst children and adolescent patients with well maintained transfusion and chelation therapy. The aim is to evaluate the biochemical markers of bone turnover in regularly transfused...

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Sultan S, Irfan SM, Ahmed SI. Biochemical Markers of Bone Turnover in Patients with β-Thalassemia Major: A Single Center Study from Southern Pakistan. Adv Hematol. 2016;2016:5437609doi: 10.1155/2016/5437609.
Sultan, S., Irfan, S. M., & Ahmed, S. I. (2016). Biochemical Markers of Bone Turnover in Patients with β-Thalassemia Major: A Single Center Study from Southern Pakistan. Advances in hematology, 20165437609. https://doi.org/10.1155/2016/5437609
Sultan, Sadia, et al. "Biochemical Markers of Bone Turnover in Patients with β-Thalassemia Major: A Single Center Study from Southern Pakistan." Advances in hematology vol. 2016 (2016): 5437609. doi: https://doi.org/10.1155/2016/5437609
Sultan S, Irfan SM, Ahmed SI. Biochemical Markers of Bone Turnover in Patients with β-Thalassemia Major: A Single Center Study from Southern Pakistan. Adv Hematol. 2016;2016:5437609. doi: 10.1155/2016/5437609. Epub 2016 Feb 23. PMID: 27006658; PMCID: PMC4783526.
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Current Concepts in Primary Biliary Cirrhosis and Primary Sclerosing Cholangitis.

Clinical and translational gastroenterology

Sclair SN, Little E, Levy C.
PMID: 26312413
Clin Transl Gastroenterol. 2015 Aug 27;6:e109. doi: 10.1038/ctg.2015.33.

Primary biliary cirrhosis (PBC) and primary sclerosing cholangitis (PSC) are chronic, cholestatic diseases of the liver with common clinical manifestations. Early diagnosis and treatment of PBC slows progression and decreases the need for transplant. However, one-third of patients will...

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Sclair SN, Little E, Levy C. Current Concepts in Primary Biliary Cirrhosis and Primary Sclerosing Cholangitis. Clin Transl Gastroenterol. 2015;6:e109doi: 10.1038/ctg.2015.33.
Sclair, S. N., Little, E., & Levy, C. (2015). Current Concepts in Primary Biliary Cirrhosis and Primary Sclerosing Cholangitis. Clinical and translational gastroenterology, 6e109. https://doi.org/10.1038/ctg.2015.33
Sclair, Seth N, et al. "Current Concepts in Primary Biliary Cirrhosis and Primary Sclerosing Cholangitis." Clinical and translational gastroenterology vol. 6 (2015): e109. doi: https://doi.org/10.1038/ctg.2015.33
Sclair SN, Little E, Levy C. Current Concepts in Primary Biliary Cirrhosis and Primary Sclerosing Cholangitis. Clin Transl Gastroenterol. 2015 Aug 27;6:e109. doi: 10.1038/ctg.2015.33. PMID: 26312413; PMCID: PMC4816277.
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A Positive Selection for Nucleoside Kinases in E. coli.

PloS one

Shelat NY, Parhi S, Ostermeier M.
PMID: 27677184
PLoS One. 2016 Sep 27;11(9):e0162921. doi: 10.1371/journal.pone.0162921. eCollection 2016.

Engineering heterologous nucleoside kinases inside E. coli is a difficult process due to the integral role nucleosides play in cell division and transcription. Nucleoside analogs are used in many kinase screens that depend on cellular metabolization of the analogs....

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Shelat NY, Parhi S, Ostermeier M. A Positive Selection for Nucleoside Kinases in E. coli. PLoS One. 2016;11(9):e0162921doi: 10.1371/journal.pone.0162921.
Shelat, N. Y., Parhi, S., & Ostermeier, M. (2016). A Positive Selection for Nucleoside Kinases in E. coli. PloS one, 11(9), e0162921. https://doi.org/10.1371/journal.pone.0162921
Shelat, Nirav Y, et al. "A Positive Selection for Nucleoside Kinases in E. coli." PloS one vol. 11,9 (2016): e0162921. doi: https://doi.org/10.1371/journal.pone.0162921
Shelat NY, Parhi S, Ostermeier M. A Positive Selection for Nucleoside Kinases in E. coli. PLoS One. 2016 Sep 27;11(9):e0162921. doi: 10.1371/journal.pone.0162921. eCollection 2016. PMID: 27677184; PMCID: PMC5038940.
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Gene-Activated Matrix Comprised of Atelocollagen and Plasmid DNA Encoding BMP4 or Runx2 Promotes Rat Cranial Bone Augmentation.

BioResearch open access

Umebayashi M, Sumita Y, Kawai Y, Watanabe S, Asahina I.
PMID: 26309793
Biores Open Access. 2015 Feb 01;4(1):164-74. doi: 10.1089/biores.2014.0057. eCollection 2015.

To date, therapeutic method for in vivo gene delivery has not been established on bone engineering though its potential usefulness has been suggested. For clinical applications, an effective condition should be developed to transfer the genes in vivo without...

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Umebayashi M, Sumita Y, Kawai Y, et al. Gene-Activated Matrix Comprised of Atelocollagen and Plasmid DNA Encoding BMP4 or Runx2 Promotes Rat Cranial Bone Augmentation. Biores Open Access. 2015;4(1):164-74doi: 10.1089/biores.2014.0057.
Umebayashi, M., Sumita, Y., Kawai, Y., Watanabe, S., & Asahina, I. (2015). Gene-Activated Matrix Comprised of Atelocollagen and Plasmid DNA Encoding BMP4 or Runx2 Promotes Rat Cranial Bone Augmentation. BioResearch open access, 4(1), 164-74. https://doi.org/10.1089/biores.2014.0057
Umebayashi, Mayumi, et al. "Gene-Activated Matrix Comprised of Atelocollagen and Plasmid DNA Encoding BMP4 or Runx2 Promotes Rat Cranial Bone Augmentation." BioResearch open access vol. 4,1 (2015): 164-74. doi: https://doi.org/10.1089/biores.2014.0057
Umebayashi M, Sumita Y, Kawai Y, Watanabe S, Asahina I. Gene-Activated Matrix Comprised of Atelocollagen and Plasmid DNA Encoding BMP4 or Runx2 Promotes Rat Cranial Bone Augmentation. Biores Open Access. 2015 Feb 01;4(1):164-74. doi: 10.1089/biores.2014.0057. eCollection 2015. PMID: 26309793; PMCID: PMC4497668.
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Role of interleukin-1 and its antagonism of hepatic stellate cell proliferation and liver fibrosis in the Abcb4(-/-) mouse model.

World journal of hepatology

Reiter FP, Wimmer R, Wottke L, Artmann R, Nagel JM, Carranza MO, Mayr D, Rust C, Fickert P, Trauner M, Gerbes AL, Hohenester S, Denk GU.
PMID: 27004088
World J Hepatol. 2016 Mar 18;8(8):401-10. doi: 10.4254/wjh.v8.i8.401.

AIM: To study the interleukin-1 (IL-1) pathway as a therapeutic target for liver fibrosis in vitro and in vivo using the ATP-binding cassette transporter b4(-/-) (Abcb4(-/-)) mouse model.METHODS: Female and male Abcb4(-/-) mice from 6 to 13 mo of...

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Reiter FP, Wimmer R, Wottke L, et al. Role of interleukin-1 and its antagonism of hepatic stellate cell proliferation and liver fibrosis in the Abcb4(-/-) mouse model. World J Hepatol. 2016;8(8):401-10doi: 10.4254/wjh.v8.i8.401.
Reiter, F. P., Wimmer, R., Wottke, L., Artmann, R., Nagel, J. M., Carranza, M. O., Mayr, D., Rust, C., Fickert, P., Trauner, M., Gerbes, A. L., Hohenester, S., & Denk, G. U. (2016). Role of interleukin-1 and its antagonism of hepatic stellate cell proliferation and liver fibrosis in the Abcb4(-/-) mouse model. World journal of hepatology, 8(8), 401-10. https://doi.org/10.4254/wjh.v8.i8.401
Reiter, Florian P, et al. "Role of interleukin-1 and its antagonism of hepatic stellate cell proliferation and liver fibrosis in the Abcb4(-/-) mouse model." World journal of hepatology vol. 8,8 (2016): 401-10. doi: https://doi.org/10.4254/wjh.v8.i8.401
Reiter FP, Wimmer R, Wottke L, Artmann R, Nagel JM, Carranza MO, Mayr D, Rust C, Fickert P, Trauner M, Gerbes AL, Hohenester S, Denk GU. Role of interleukin-1 and its antagonism of hepatic stellate cell proliferation and liver fibrosis in the Abcb4(-/-) mouse model. World J Hepatol. 2016 Mar 18;8(8):401-10. doi: 10.4254/wjh.v8.i8.401. PMID: 27004088; PMCID: PMC4794530.
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The intestinal epithelial cell differentiation marker intestinal alkaline phosphatase (ALPi) is selectively induced by histone deacetylase inhibitors (HDACi) in colon cancer cells in a Kruppel-like factor 5 (KLF5)-dependent manner.

The Journal of biological chemistry

Shin J, Carr A, Corner GA, Tögel L, Dávalos-Salas M, Tran H, Chueh AC, Al-Obaidi S, Chionh F, Ahmed N, Buchanan DD, Young JP, Malo MS, Hodin RA, Arango D, Sieber OM, Augenlicht LH, Dhillon AS, Weber TK, Mariadason JM.
PMID: 26092983
J Biol Chem. 2015 Jun 19;290(25):15392. doi: 10.1074/jbc.A114.557546.

No abstract available.

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Shin J, Carr A, Corner GA, et al. The intestinal epithelial cell differentiation marker intestinal alkaline phosphatase (ALPi) is selectively induced by histone deacetylase inhibitors (HDACi) in colon cancer cells in a Kruppel-like factor 5 (KLF5)-dependent manner. J Biol Chem. 2015;290(25):15392doi: 10.1074/jbc.A114.557546.
Shin, J., Carr, A., Corner, G. A., Tögel, L., Dávalos-Salas, M., Tran, H., Chueh, A. C., Al-Obaidi, S., Chionh, F., Ahmed, N., Buchanan, D. D., Young, J. P., Malo, M. S., Hodin, R. A., Arango, D., Sieber, O. M., Augenlicht, L. H., Dhillon, A. S., Weber, T. K., & Mariadason, J. M. (2015). The intestinal epithelial cell differentiation marker intestinal alkaline phosphatase (ALPi) is selectively induced by histone deacetylase inhibitors (HDACi) in colon cancer cells in a Kruppel-like factor 5 (KLF5)-dependent manner. The Journal of biological chemistry, 290(25), 15392. https://doi.org/10.1074/jbc.A114.557546
Shin, Joongho, et al. "The intestinal epithelial cell differentiation marker intestinal alkaline phosphatase (ALPi) is selectively induced by histone deacetylase inhibitors (HDACi) in colon cancer cells in a Kruppel-like factor 5 (KLF5)-dependent manner." The Journal of biological chemistry vol. 290,25 (2015): 15392. doi: https://doi.org/10.1074/jbc.A114.557546
Shin J, Carr A, Corner GA, Tögel L, Dávalos-Salas M, Tran H, Chueh AC, Al-Obaidi S, Chionh F, Ahmed N, Buchanan DD, Young JP, Malo MS, Hodin RA, Arango D, Sieber OM, Augenlicht LH, Dhillon AS, Weber TK, Mariadason JM. The intestinal epithelial cell differentiation marker intestinal alkaline phosphatase (ALPi) is selectively induced by histone deacetylase inhibitors (HDACi) in colon cancer cells in a Kruppel-like factor 5 (KLF5)-dependent manner. J Biol Chem. 2015 Jun 19;290(25):15392. doi: 10.1074/jbc.A114.557546. PMID: 26092983; PMCID: PMC4505454.
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Ameliorative effects of β-sitosterol on some biochemical indices of hypertension in wistar albino rats.

African journal of medicine and medical sciences

Olaiya CO, Esan AM, Alabi TD.
PMID: 26690542
Afr J Med Med Sci. 2014 Sep;43:157-166.

BACKGROUND: Cardiovascular diseases presently rank high as leading causes of death globally. The increasing acceptability of phytomedicine is due to the increasing inefficacy of many modern drugs used for the control of many diseases. The aim of this study...

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Olaiya CO, Esan AM, Alabi TD. Ameliorative effects of β-sitosterol on some biochemical indices of hypertension in wistar albino rats. Afr J Med Med Sci. 2014;43:157-166
Olaiya, C. O., Esan, A. M., & Alabi, T. D. (2014). Ameliorative effects of β-sitosterol on some biochemical indices of hypertension in wistar albino rats. African journal of medicine and medical sciences, 43157-166.
Olaiya, C O, et al. "Ameliorative effects of β-sitosterol on some biochemical indices of hypertension in wistar albino rats." African journal of medicine and medical sciences vol. 43 (2014): 157-166.
Olaiya CO, Esan AM, Alabi TD. Ameliorative effects of β-sitosterol on some biochemical indices of hypertension in wistar albino rats. Afr J Med Med Sci. 2014 Sep;43:157-166. PMID: 26690542; PMCID: PMC4681395.
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Curcumin implants for continuous systemic delivery: safety and biocompatibility.

Drug delivery and translational research

Bansal SS, Kausar H, Aqil F, Jeyabalan J, Vadhanam MV, Gupta RC, Ravoori S.
PMID: 25788367
Drug Deliv Transl Res. 2011 Aug;1(4):332-41. doi: 10.1007/s13346-011-0028-0.

Curcumin, an anti-oxidant, anti-inflammatory, and anti-neoplastic agent, exhibited limited oral efficacy due to its poor bioavailability. To overcome this limitation, polymeric implants for continuous systemic delivery of curcumin were developed and tested for their safety and biocompatibility. Two 2-cm...

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Bansal SS, Kausar H, Aqil F, et al. Curcumin implants for continuous systemic delivery: safety and biocompatibility. Drug Deliv Transl Res. 2011;1(4):332-41doi: 10.1007/s13346-011-0028-0.
Bansal, S. S., Kausar, H., Aqil, F., Jeyabalan, J., Vadhanam, M. V., Gupta, R. C., & Ravoori, S. (2011). Curcumin implants for continuous systemic delivery: safety and biocompatibility. Drug delivery and translational research, 1(4), 332-41. https://doi.org/10.1007/s13346-011-0028-0
Bansal, Shyam S, et al. "Curcumin implants for continuous systemic delivery: safety and biocompatibility." Drug delivery and translational research vol. 1,4 (2011): 332-41. doi: https://doi.org/10.1007/s13346-011-0028-0
Bansal SS, Kausar H, Aqil F, Jeyabalan J, Vadhanam MV, Gupta RC, Ravoori S. Curcumin implants for continuous systemic delivery: safety and biocompatibility. Drug Deliv Transl Res. 2011 Aug;1(4):332-41. doi: 10.1007/s13346-011-0028-0. PMID: 25788367.
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Angiotensin II suppresses osteoblastic differentiation and mineralized nodule formation via AT1 receptor in ROS17/2.8 cells.

Archives of medical science : AMS

Nakai K, Kawato T, Morita T, Yamazaki Y, Tanaka H, Tonogi M, Oki H, Maeno M.
PMID: 26170858
Arch Med Sci. 2015 Jun 19;11(3):628-37. doi: 10.5114/aoms.2015.52369.

INTRODUCTION: Angiotensin II (Ang II) not only regulates systemic blood pressure through a vasoconstrictive effect, but also promotes bone resorption. We recently reported that Ang II (10(-6) M) stimulated the production of matrix metalloproteinases via the AT1 receptor in...

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Nakai K, Kawato T, Morita T, et al. Angiotensin II suppresses osteoblastic differentiation and mineralized nodule formation via AT1 receptor in ROS17/2.8 cells. Arch Med Sci. 2015;11(3):628-37doi: 10.5114/aoms.2015.52369.
Nakai, K., Kawato, T., Morita, T., Yamazaki, Y., Tanaka, H., Tonogi, M., Oki, H., & Maeno, M. (2015). Angiotensin II suppresses osteoblastic differentiation and mineralized nodule formation via AT1 receptor in ROS17/2.8 cells. Archives of medical science : AMS, 11(3), 628-37. https://doi.org/10.5114/aoms.2015.52369
Nakai, Kumiko, et al. "Angiotensin II suppresses osteoblastic differentiation and mineralized nodule formation via AT1 receptor in ROS17/2.8 cells." Archives of medical science : AMS vol. 11,3 (2015): 628-37. doi: https://doi.org/10.5114/aoms.2015.52369
Nakai K, Kawato T, Morita T, Yamazaki Y, Tanaka H, Tonogi M, Oki H, Maeno M. Angiotensin II suppresses osteoblastic differentiation and mineralized nodule formation via AT1 receptor in ROS17/2.8 cells. Arch Med Sci. 2015 Jun 19;11(3):628-37. doi: 10.5114/aoms.2015.52369. PMID: 26170858; PMCID: PMC4495158.
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Effect of calcitriol supplementation and tail suspension on serum biomarkers of bone formation in rats.

Journal of diabetes and metabolic disorders

Hashemian SJ, Rismanchi M, Esfahani EN, Khoshvaghti A, Razi F.
PMID: 25806360
J Diabetes Metab Disord. 2015 Mar 19;14:14. doi: 10.1186/s40200-015-0142-5. eCollection 2015.

BACKGROUND: Calcitriol is documented to cause significant increase in bone mass densitometry counteracting osteoporosis. Promising results of calcitriol supplementation in studies aiming space flight induced osteoporosis is little and the effect of this hormone on biomarkers of bone metabolism...

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Hashemian SJ, Rismanchi M, Esfahani EN, et al. Effect of calcitriol supplementation and tail suspension on serum biomarkers of bone formation in rats. J Diabetes Metab Disord. 2015;14:14doi: 10.1186/s40200-015-0142-5.
Hashemian, S. J., Rismanchi, M., Esfahani, E. N., Khoshvaghti, A., & Razi, F. (2015). Effect of calcitriol supplementation and tail suspension on serum biomarkers of bone formation in rats. Journal of diabetes and metabolic disorders, 1414. https://doi.org/10.1186/s40200-015-0142-5
Hashemian, Seyed Jafar, et al. "Effect of calcitriol supplementation and tail suspension on serum biomarkers of bone formation in rats." Journal of diabetes and metabolic disorders vol. 14 (2015): 14. doi: https://doi.org/10.1186/s40200-015-0142-5
Hashemian SJ, Rismanchi M, Esfahani EN, Khoshvaghti A, Razi F. Effect of calcitriol supplementation and tail suspension on serum biomarkers of bone formation in rats. J Diabetes Metab Disord. 2015 Mar 19;14:14. doi: 10.1186/s40200-015-0142-5. eCollection 2015. PMID: 25806360; PMCID: PMC4371718.
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