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    DRUG CLASS:

    VP35 protein inhibitor

    Related drugs:
    2ms
    Ampligen Combined With SOC Versus SOC Alone Following First-Line Therapy in Subjects With LAPC (clinicaltrials.gov)
    P2, N=90, Suspended, AIM ImmunoTech Inc. | Trial completion date: Oct 2028 --> Jan 2030 | Trial primary completion date: Sep 2028 --> Dec 2029
    Trial completion date • Trial primary completion date
    |
    Ampligen (rintatolimod)
    3ms
    Synergy between TLR3-ligand and IFN-α in the transient sensitization of "Cold" tumors to PD-1 blockade and the induction of systemic immunity. (PubMed, J Immunother Cancer)
    The ability of systemic CKM to eliminate the PD-1-resistance of cold tumors indicates that intratumoral CTL accumulation, rather than tumor immunogenicity, is the key factor limiting the therapeutic effectiveness of ICI. These data suggest a broad therapeutic potential of TME-reprogramming strategies.
    Journal • PD(L)-1 Biomarker • IO biomarker
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    CD8 (cluster of differentiation 8) • CXCL10 (Chemokine (C-X-C motif) ligand 10) • CXCL9 (Chemokine (C-X-C motif) ligand 9) • TLR3 (Toll Like Receptor 3) • CXCR3 (C-X-C Motif Chemokine Receptor 3) • IFNA1 (Interferon Alpha 1) • BATF3 (Basic Leucine Zipper ATF-Like Transcription Factor 3)
    |
    Ampligen (rintatolimod)
    3ms
    NCI-2019-01192: Aspirin and Rintatolimod With or Without Interferon-alpha 2b in Treating Patients With Prostate Cancer Before Surgery (clinicaltrials.gov)
    P2, N=12, Active, not recruiting, Roswell Park Cancer Institute | Recruiting --> Active, not recruiting | N=30 --> 12 | Trial primary completion date: Nov 2026 --> Jun 2025
    Enrollment closed • Enrollment change • Trial primary completion date
    |
    Intron A (interferon α-2b) • Ampligen (rintatolimod) • aspirin
    5ms
    Rintatolimod, Celecoxib and Interferon Alpha 2b With Pembrolizumab For the Treatment of Patients With Metastatic or Unresectable Triple Negative Breast Cancer (clinicaltrials.gov)
    P1/2, N=5, Terminated, Roswell Park Cancer Institute | Trial completion date: Dec 2025 --> Jun 2025 | Active, not recruiting --> Terminated; Funding ended
    Trial completion date • Trial termination
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    PD-L1 expression • PD-L1 negative
    |
    Keytruda (pembrolizumab) • Ampligen (rintatolimod) • Bioferon (interferon alpha 2b) • celecoxib oral
    5ms
    Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma (clinicaltrials.gov)
    P2, N=1, Terminated, Roswell Park Cancer Institute | Trial completion date: Apr 2026 --> Jun 2025 | Active, not recruiting --> Terminated; Funding completed
    Trial completion date • Trial termination
    |
    Intron A (interferon α-2b) • Ampligen (rintatolimod) • aDC1 vaccine • celecoxib oral
    7ms
    Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma (clinicaltrials.gov)
    P2, N=1, Active, not recruiting, Roswell Park Cancer Institute | Recruiting --> Active, not recruiting | N=24 --> 1 | Trial completion date: Nov 2027 --> Apr 2026 | Trial primary completion date: Nov 2027 --> Apr 2025
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    Intron A (interferon α-2b) • Ampligen (rintatolimod) • aDC1 vaccine • celecoxib oral
    7ms
    Rintatolimod, Celecoxib and Interferon Alpha 2b With Pembrolizumab For the Treatment of Patients With Metastatic or Unresectable Triple Negative Breast Cancer (clinicaltrials.gov)
    P1/2, N=5, Active, not recruiting, Roswell Park Cancer Institute | Recruiting --> Active, not recruiting | N=15 --> 5 | Trial completion date: Jun 2025 --> Dec 2025
    Enrollment closed • Enrollment change • Trial completion date
    |
    PD-L1 expression • PD-L1 negative
    |
    Keytruda (pembrolizumab) • Ampligen (rintatolimod) • Bioferon (interferon alpha 2b) • celecoxib oral
    8ms
    NCI-2019-01192: Aspirin and Rintatolimod With or Without Interferon-alpha 2b in Treating Patients With Prostate Cancer Before Surgery (clinicaltrials.gov)
    P2, N=30, Recruiting, Roswell Park Cancer Institute | Suspended --> Recruiting | Trial completion date: May 2026 --> Nov 2026 | Trial primary completion date: May 2026 --> Nov 2026
    Enrollment open • Trial completion date • Trial primary completion date
    |
    Intron A (interferon α-2b) • Ampligen (rintatolimod) • aspirin
    9ms
    Ampligen Combined With SOC Versus SOC Alone Following First-Line Therapy in Subjects With LAPC (clinicaltrials.gov)
    P2, N=90, Suspended, AIM ImmunoTech Inc. | Recruiting --> Suspended
    Trial suspension
    |
    Ampligen (rintatolimod)
    9ms
    Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma (clinicaltrials.gov)
    P2, N=24, Recruiting, Roswell Park Cancer Institute | Trial completion date: Nov 2025 --> Nov 2027 | Trial primary completion date: Nov 2025 --> Nov 2027
    Trial completion date • Trial primary completion date • IO biomarker
    |
    CD8 (cluster of differentiation 8)
    |
    Intron A (interferon α-2b) • Ampligen (rintatolimod) • aDC1 vaccine • celecoxib oral
    10ms
    Ampligen Combined With SOC Versus SOC Alone Following First-Line Therapy in Subjects With LAPC (clinicaltrials.gov)
    P2, N=90, Recruiting, AIM ImmunoTech Inc. | Trial completion date: Jul 2028 --> Oct 2028 | Trial primary completion date: Jun 2028 --> Sep 2028
    Trial completion date • Trial primary completion date
    |
    Ampligen (rintatolimod)
    1year
    Systemic chemokine-modulatory regimen combined with neoadjuvant chemotherapy in patients with triple-negative breast cancer. (PubMed, J Immunother Cancer)
    Combined paclitaxel/CKM regimen was safe, with desirable TME changes and preliminary indications of promising pCR+ypTmic of 66%, comparable to the combination of NAC with pembrolizumab.
    Journal
    |
    FOXP3 (Forkhead Box P3) • TLR3 (Toll Like Receptor 3) • IFNA1 (Interferon Alpha 1)
    |
    Keytruda (pembrolizumab) • paclitaxel • doxorubicin hydrochloride • cyclophosphamide • Ampligen (rintatolimod) • celecoxib oral