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    DRUG:

    perillyl alcohol (NEO100)

    i
    Other names: NEO100, POH, NEO-100
    Company:
    NeOnc Technologies
    Drug class:
    Apoptosis stimulant, RAS inhibitor
    Related drugs:
    29d
    Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma (clinicaltrials.gov)
    P1/2, N=49, Recruiting, Neonc Technologies, Inc. | Trial primary completion date: Jun 2024 --> Dec 2024
    Trial primary completion date
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 mutation
    |
    perillyl alcohol (NEO100)
    30d
    A Study of the Safety, Dosing, and Delivery of NEO100 in Patients with Pediatric Brain Tumors (clinicaltrials.gov)
    P1, N=15, Not yet recruiting, Neonc Technologies, Inc. | Trial completion date: Oct 2024 --> Oct 2025 | Initiation date: May 2024 --> Dec 2024 | Trial primary completion date: Oct 2024 --> Oct 2025
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    perillyl alcohol (NEO100)
    5ms
    Molecular pharmacology and therapeutic advances of monoterpene perillyl alcohol. (PubMed, Phytomedicine)
    This review systematically summarizes the recent advances in POH and highlights its therapeutic effects and potential mechanisms as well as the clinical settings, which is helpful to develop POH into functional food and new candidate drug for prevention and management of diseases. Future studies are needed to conduct more biological activity studies of POH and its derivatives, and check their clinical efficacy and potential side effects.
    Review • Journal
    |
    BCL2 (B-cell CLL/lymphoma 2) • CCND1 (Cyclin D1) • HIF1A (Hypoxia inducible factor 1, alpha subunit) • STAT3 (Signal Transducer And Activator Of Transcription 3) • PARP1 (Poly(ADP-Ribose) Polymerase 1) • BAX (BCL2-associated X protein) • CASP3 (Caspase 3) • CDKN1A (Cyclin-dependent kinase inhibitor 1A) • NLRP3 (NLR Family Pyrin Domain Containing 3) • NOS3 (Nitric oxide synthase 3)
    |
    perillyl alcohol (NEO100)
    7ms
    A Study of the Safety, Dosing, and Delivery of NEO100 in Patients With Pediatric Brain Tumors (clinicaltrials.gov)
    P1, N=15, Not yet recruiting, Neonc Technologies, Inc.
    New P1 trial
    |
    perillyl alcohol (NEO100)
    1year
    Inhibition of autophagy and induction of glioblastoma cell death by NEO214, a perillyl alcohol-rolipram conjugate. (PubMed, Autophagy)
    When combined with chloroquine and TMZ, the anticancer impact of NEO214 is further potentiated and unfolds against TMZ-resistant cells as well. Taken together, our findings characterize NEO214 as a novel autophagy inhibitor that could become useful for overcoming chemoresistance in glioblastoma.Abbreviations: ATG: autophagy related; BAFA1: bafilomycin A; BBB: blood brain barrier; CQ: chloroquine; GBM: glioblastoma; LAMP1: lysosomal associated membrane protein 1; MAP1LC3/LC3: microtubule associated protein 1 light chain 3; MGMT: O-6-methylguanine-DNA methyltransferase; MTOR: mechanistic target of rapamycin kinase; MTORC: MTOR complex; POH: perillyl alcohol; SQSTM1/p62: sequestosome 1; TFEB: transcription factor EB; TMZ: temozolomide.
    Journal
    |
    SQSTM1 (Sequestosome 1) • LAMP1 (Lysosomal Associated Membrane Protein 1) • TFEB (Transcription Factor EB 2)
    |
    temozolomide • sirolimus • perillyl alcohol (NEO100)
    almost2years
    Enhanced brain entry of checkpoint-inhibitory therapeutic antibodies facilitated by intraarterial NEO100 in mouse models of brain-localized malignancies. (PubMed, J Neurosurg)
    BBB opening by IA NEO100 facilitates brain tumor access by checkpoint-inhibitory antibodies and enables their therapeutic activity, along with increased levels of T-cell recruitment.
    Preclinical • Journal • Checkpoint inhibition
    |
    CD8 (cluster of differentiation 8)
    |
    perillyl alcohol (NEO100)
    2years
    Safety and Efficacy Study in Recurrent Grade IV Glioma (clinicaltrials.gov)
    P1/2, N=49, Recruiting, Neonc Technologies, Inc. | Trial completion date: Dec 2022 --> Dec 2024 | Trial primary completion date: Jun 2022 --> Jun 2024
    Trial completion date • Trial primary completion date
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 mutation
    |
    perillyl alcohol (NEO100)
    3years
    Safety and Efficacy Study in Recurrent Grade IV Glioma (clinicaltrials.gov)
    P1/2, N=49, Recruiting, Neonc Technologies, Inc. | Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Jun 2021 --> Jun 2022
    Clinical • Trial completion date • Trial primary completion date
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 mutation
    |
    perillyl alcohol (NEO100)
    over3years
    Perillyl alcohol for pediatric TP53- and RAS-mutated SHH-medulloblastoma: an in vitro and in vivo translational pre-clinical study. (PubMed, Childs Nerv Syst)
    POH presents robust in vitro antimedulloblastoma effects and sensitizes cell lines to other conventional therapeutics, reducing tumor volume when administered intraperitoneally. Nevertheless, further improvement of delivery devices and/or drug formulations are needed to better characterize its effectiveness through inhalation.
    Preclinical • Journal
    |
    TP53 (Tumor protein P53) • NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    TP53 mutation • NRAS mutation
    |
    methotrexate • thiotepa • perillyl alcohol (NEO100)
    over3years
    Phase I trial of intranasal NEO100, highly purified perillyl alcohol, in adult patients with recurrent glioblastoma. (PubMed, Neurooncol Adv)
    Intranasal glioma therapy with NEO100 was well tolerated. It correlated with improved survival when compared to historical controls, pointing to the possibility that this novel intranasal approach could become useful for the treatment of recurrent GBM.
    Clinical • Journal
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 mutation
    |
    perillyl alcohol (NEO100)