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    DRUG CLASS:

    Ornithine decarboxylase inhibitor

    Related drugs:
    5ms
    Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma (clinicaltrials.gov)
    P1, N=66, Recruiting, Orbus Therapeutics, Inc. | Trial completion date: Dec 2024 --> Jun 2026 | Trial primary completion date: Dec 2024 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    IDH wild-type
    |
    temozolomide • eflornithine
    7ms
    DFMO Maintenance for Patients With Relapsed/Refractory Ewing Sarcoma or Osteosarcoma (clinicaltrials.gov)
    P1/2, N=15, Recruiting, Montefiore Medical Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Iwilfin (eflornithine)
    9ms
    DFMO Maintenance for Patients With Relapsed/Refractory Ewing Sarcoma or Osteosarcoma (clinicaltrials.gov)
    P1/2, N=15, Not yet recruiting, Montefiore Medical Center
    New P1/2 trial
    |
    Iwilfin (eflornithine)
    9ms
    Preclinical evaluation of the efficacy of α-Difluoromethylornithine and Sulindac against SARS-CoV-2 infection. (PubMed, bioRxiv)
    The treatment regime was ineffective in suppressing SARS-CoV-2 infection in K18-hACE2 mice. Overall, animal studies demonstrated the protective age- and sex-dependent antiviral efficacy of DFMO and Sulindac against SARS-CoV-2.
    Preclinical • Journal
    |
    ACE2 (Angiotensin Converting Enzyme 2)
    |
    Flynpovi (eflornithine/sulindac)
    over1year
    Disrupting YAP1-mediated glutamine metabolism induces synthetic lethality alongside ODC1 inhibition in osteosarcoma. (PubMed, Cell Oncol (Dordr))
    Our findings elucidate YAP1-mediated glutamine metabolism as a crucial bypass mechanism against DFMO, following the inhibition of polyamine metabolism. Our study provides valuable insights into the potential role of DFMO in an "One-two Punch" therapy of metastatic and recurrent osteosarcoma.
    Journal • Synthetic lethality
    |
    MTAP (Methylthioadenosine Phosphorylase) • YAP1 (Yes associated protein 1)
    |
    telaglenastat (CB-839)
    over1year
    Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma (clinicaltrials.gov)
    P1, N=66, Recruiting, Orbus Therapeutics, Inc. | Phase classification: P1b --> P1
    Phase classification
    |
    IDH wild-type
    |
    temozolomide • eflornithine
    over1year
    ASPIRE: Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Pancreatic Cancer (clinicaltrials.gov)
    P2/3, N=600, Recruiting, Panbela Therapeutics, Inc. | N=150 --> 600 | Trial completion date: May 2024 --> Jan 2027 | Trial primary completion date: May 2024 --> Aug 2026
    Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    gemcitabine • albumin-bound paclitaxel • ivospemin (SBP-101)
    2years
    Effect of Ivospemin and Difluoromethylornithine Polyamine Inhibitors on Viability of Myeloma Cell Lines (ASH 2023)
    The polyamine inhibitors,Ivospemin and DFMO, exhibited a marked anti-proliferative effect in the four human MM cell lines studied when used alone or in combination. These results confirm the anti-neoplastic potential of SBP-101 and DFMO and offer a compelling rationale for its clinical development as a potentially promising treatment option for multiple myeloma. Fig.
    Preclinical
    |
    ANXA5 (Annexin A5)
    |
    ivospemin (SBP-101)
    2years
    PACES: S0820, Adenoma and Second Primary Prevention Trial (clinicaltrials.gov)
    P3, N=354, Active, not recruiting, SWOG Cancer Research Network | Recruiting --> Active, not recruiting | N=1340 --> 354
    Enrollment closed • Enrollment change
    |
    Flynpovi (eflornithine/sulindac)
    over2years
    Chemoprevention of Colon Cancer by DFMO, Sulindac, and NO-Sulindac Administered Individually or in Combinations in F344 Rats. (PubMed, Cancers (Basel))
    In addition, enhancement of p21, Bax, and caspases; downregulation of Ki-67, VEGF, and β-catenin; and modulation of iNOS, COX-2, and ODC activities in colonic tumors were observed. These observations show that a lower-dose of DFMO and Sulindac significantly enhanced CRC chemopreventive efficacy when compared to NO-Sulindac alone, and the combination of DFMO and NO-Sulindac was modestly efficacious as compared to DFMO alone.
    Preclinical • Journal
    |
    CTNNB1 (Catenin (cadherin-associated protein), beta 1) • CDKN1A (Cyclin-dependent kinase inhibitor 1A)
    |
    Flynpovi (eflornithine/sulindac)
    over2years
    Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma (clinicaltrials.gov)
    P1b, N=60, Recruiting, Orbus Therapeutics, Inc.
    New P1 trial
    |
    IDH wild-type
    |
    temozolomide • eflornithine
    3years
    MicroRNA-378a-3p prevents initiation and growth of colorectal cancer by fine tuning polyamine synthesis. (PubMed, Cell Biosci)
    MiR-378a prevents CRC by inhibiting polyamine synthesis, suggesting its use as a novel ODC inhibitor against CRC.
    Journal
    |
    MYC (V-myc avian myelocytomatosis viral oncogene homolog) • MIR378A (MicroRNA 378a) • ODC1 (Ornithine Decarboxylase 1)