// Publications

Science that holds up to scrutiny.

Peer-reviewed publications provide an important scientific and clinical foundation for Phoenix Biotechnology’s programs. This page brings together selected company-associated studies, relevant independent research, and links to source records for further review.

// library

Selected Scientific Publications

Human clinical trials

  • Hong DS, et al. First-in-human study of PBI-05204, an oleander-derived inhibitor of Akt, FGF-2, NF-κB and p70S6K, in patients with advanced solid tumors. Invest New Drugs. 2014;32(6):1204–1212.

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  • Roth MT, et al. A Phase II, single-arm, open-label, Bayesian adaptive efficacy and safety study of PBI-05204 in patients with Stage IV metastatic pancreatic adenocarcinoma. Oncologist. 2020;25(10):e1446–e1450.

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  • Mekhail T, et al. Phase 1 trial of Anvirzel™ in patients with refractory solid tumors. Invest New Drugs. 2006;24(5):423–427.

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Antiviral

  • Plante KS, et al. Antiviral activity of oleandrin and a defined extract of Nerium oleander against SARS-CoV-2. Biomed Pharmacother. 2021;138:111457.

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  • Newman RA, et al. Antiviral effects of oleandrin. J Exp Pharmacol. 2020;12:503-515.

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  • Hutchison T, et al. The botanical glycoside oleandrin inhibits human T-cell leukemia virus type-1 infectivity and Env-dependent virological synapse formation. J Antivir Antiretrovir. 2019;11(3):184.

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  • Singh S, et al. Nerium oleander derived cardiac glycoside oleandrin is a novel inhibitor of HIV infectivity. Fitoterapia. 2013;84:32–39.

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  • Ha DP, et al. Targeting stress induction of GRP78 by cardiac glycoside oleandrin dually suppresses cancer and COVID-19. Cell Biosci. 2024;14(1):115.

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Neuroprotection and neurodegeneration

  • Dunn DE, et al. In vitro and in vivo neuroprotective activity of the cardiac glycoside oleandrin. J Neurochem. 2011;119(4):805–814.

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  • Van Kanegan MJ, et al. BDNF mediates neuroprotection against oxygen-glucose deprivation by the cardiac glycoside oleandrin. J Neurosci. 2014;34(3):963–968.

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  • Van Kanegan MJ, et al. Dual activities of the anti-cancer drug candidate PBI-05204 provide neuroprotection in brain slice models for neurodegenerative diseases and stroke. Sci Rep. 2016;6:25626.

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Oncology: mechanisms and preclinical evidence

  • Pan Y, et al. PBI-05204, a supercritical CO₂ extract of Nerium oleander, inhibits growth of human pancreatic cancer via targeting the PI3K/mTOR pathway. Invest New Drugs. 2015;33(2):271–279.

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  • Colapietro A, et al. The botanical drug PBI-05204, a supercritical CO₂ extract of Nerium oleander, inhibits growth of human glioblastoma, reduces Akt/mTOR activities, and modulates GSC cell-renewal properties. Front Pharmacol. 2020;11:552428.

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  • Colapietro A, et al. The botanical drug PBI-05204, a supercritical CO₂ extract of Nerium oleander, is synergistic with radiotherapy in models of human glioblastoma. Front Pharmacol. 2022;13:852941.

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  • Vaccaro S, et al. The botanical drug PBI-05204, a supercritical CO₂ extract of Nerium oleander, sensitizes alveolar and embryonal rhabdomyosarcoma to radiotherapy in vitro and in vivo. Front Pharmacol. 2022;13:1071176.

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  • Chakraborty S, et al. PBI-05204, a supercritical CO₂ extract of Nerium oleander, suppresses glioblastoma stem cells by inhibiting GRP78 and inducing programmed necroptotic cell death. Neoplasia. 2024;54:101008.

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  • Yang P, et al. Oleandrin-mediated inhibition of human tumor cell proliferation: importance of Na,K-ATPase alpha subunits as drug targets. Mol Cancer Ther. 2009;8(8):2319–2328.

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  • Newman RA, et al. Cardiac glycosides as novel cancer therapeutic agents. Mol Interv. 2008;8(1):36–49.

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Immunomodulation and cytoprotection

  • Manna SK, et al. Oleandrin suppresses activation of nuclear transcription factor-kappaB, activator protein-1, and c-Jun NH₂-terminal kinase. Cancer Res. 2000;60(14):3838–3847.

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  • Jensen GS, et al. Differential activities of the botanical extract PBI-05204 and oleandrin on innate immune functions under viral challenge versus inflammatory culture conditions. Molecules. 2023;28(12):4799.

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  • Dey P, et al. Oleander attenuates hepatic inflammation in a TLR4-independent manner and by favorable modulation of hepatocellular global metabolome that supports cytoprotection. J Ethnopharmacol. 2024;323:117717.

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Veterinary and animal health

  • Newman RA, et al. Efficacy of oleandrin and PBI-05204 against bovine viruses of importance to commercial cattle health. Antivir Chem Chemother. 2022;30:20402066221103960.

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  • Newman RA, et al. Efficacy of oleandrin and PBI-05204 against viruses of importance to commercial pig health management. Front Anim Sci. 2024;5:1359681.

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  • Fossum TW, Newman RA, Matos JR. Preliminary investigation of the safe dose of oleandrin when administered orally to Beagles. J Am Vet Med Assoc. 2024;262(7):966–972.

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  • Fossum TW, et al. Botanical oleander extract and oleandrin have superior effects on innate immune functions pertaining to dermal allergic reactions in canine cells when compared to oclacitinib. Am J Vet Res. 2024;85(12):ajvr.24.05.0153.

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Analytical methods and pharmacokinetics

  • Wang X, et al. LC/MS/MS analyses of an oleander extract for cancer treatment. Anal Chem. 2000;72(15):3547–3552.

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  • Ni D, et al. Murine pharmacokinetics and metabolism of oleandrin, a cytotoxic component of Nerium oleander. J Exp Ther Oncol. 2002;2(5):278–285.

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// collaborators

Collaborators

Research supporting Phoenix’s programs has involved institutions and organizations across government, academia, and specialized research, including:

  • U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID)
  • Duke University
  • The University of Texas MD Anderson Cancer Center
  • Johns Hopkins
  • U.S. Centers for Disease Control and Prevention (CDC)
  • World Reference Center for Emerging Viruses and Arboviruses
  • University of Texas Medical Branch
  • Southern Methodist University
  • Texas Biomedical Research Institute
  • NIS Labs