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DRUG:

Ampligen (rintatolimod)

i
Other names: poly I-poly C12U, poly(I) poly(C12,U)
Company:
AIM ImmunoTech
Drug class:
TLR3 agonist, VP35 protein inhibitor
3d
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
8d
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: Apr 2028 --> Jul 2028 | Trial primary completion date: Mar 2028 --> Jun 2028
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
Ampligen (rintatolimod)
3ms
Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines (clinicaltrials.gov)
P1/2, N=25, Recruiting, Roswell Park Cancer Institute | Suspended --> Recruiting
Enrollment open • Metastases
|
IFNG (Interferon, gamma) • CXCL10 (Chemokine (C-X-C motif) ligand 10) • CXCL12 (C-X-C Motif Chemokine Ligand 12) • CXCL9 (Chemokine (C-X-C motif) ligand 9) • CD4 (CD4 Molecule) • IL10 (Interleukin 10) • CXCL11 (C-X-C Motif Chemokine Ligand 11) • CCL2 (Chemokine (C-C motif) ligand 2) • ITGAM (Integrin, alpha M) • FOXP3 (Forkhead Box P3) • CCL22 (C-C Motif Chemokine Ligand 22) • CCL3 (C-C Motif Chemokine Ligand 3) • ITGAX (Integrin Subunit Alpha X)
|
cisplatin • Ampligen (rintatolimod) • aDC1 vaccine • celecoxib oral
4ms
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: Aug 2025 --> Nov 2025 | Trial primary completion date: Aug 2025 --> Nov 2025
Trial completion date • Trial primary completion date • Combination therapy • IO biomarker
|
CD8 (cluster of differentiation 8)
|
Intron A (interferon α-2b) • Ampligen (rintatolimod) • aDC1 vaccine • celecoxib oral
4ms
Ampligen Compared to No Treatment Following FOLFIRINOX in Subjects With Locally Advanced Pancreatic Adenocarcinoma (clinicaltrials.gov)
P2, N=90, Recruiting, AIM ImmunoTech Inc. | Trial completion date: Jul 2027 --> Apr 2028 | Trial primary completion date: Jun 2027 --> Mar 2028
Trial completion date • Trial primary completion date • Metastases
|
5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • Ampligen (rintatolimod)
4ms
Therapeutic Anti-Tumor Efficacy of DC-Based Vaccines Targeting TME-Associated Antigens Is Improved When Combined with a Chemokine-Modulating Regimen and/or Anti-PD-L1. (PubMed, Vaccines (Basel))
We also evaluated whether combination vaccines incorporating anti-PD-L1 checkpoint blockade and/or a chemokine-modulating (CKM; IFNα + TLR3-L [rintatolimod] + Celecoxib) regimen would improve T cell infiltration/functionality in tumors yielding enhanced treatment benefits. Peptide-based vaccines that selectively target either melanoma antigens or TBVAs elicited a CD8+ T cell repertoire recognizing both tumor cells and tumor-associated VECs and pericytes in vitro, consistent with a treatment-induced epitope spreading mechanism. Notably, combination vaccines including anti-PD-L1 + CKM yielded superior therapeutic effects on tumor growth and animal survival, in association with the potentiation of polyfunctional CD8+ T cell reactivity against both tumor cells and tumor-associated vascular cells and a pro-inflammatory TME.
Journal
|
CD8 (cluster of differentiation 8) • TLR3 (Toll Like Receptor 3) • IFNA1 (Interferon Alpha 1)
|
Ampligen (rintatolimod) • celecoxib oral
4ms
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, Suspended, Roswell Park Cancer Institute | Trial completion date: May 2024 --> May 2026 | Trial primary completion date: May 2024 --> May 2026
Trial completion date • Trial primary completion date • Surgery
|
Intron A (interferon α-2b) • Ampligen (rintatolimod) • aspirin
6ms
Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer (clinicaltrials.gov)
P1/2, N=45, Recruiting, Robert Edwards | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2026
Trial completion date • Trial primary completion date • Checkpoint inhibition • Checkpoint block
|
CD4 (CD4 Molecule)
|
Keytruda (pembrolizumab) • cisplatin • Ampligen (rintatolimod)
6ms
Trial completion date • Combination therapy • IO biomarker
|
CD8 (cluster of differentiation 8)
|
Intron A (interferon α-2b) • Ampligen (rintatolimod) • aDC1 vaccine • celecoxib oral
6ms
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=12, Recruiting, Roswell Park Cancer Institute | Trial completion date: Dec 2025 --> Jun 2025 | Trial primary completion date: Dec 2025 --> Jun 2025
Trial completion date • Trial primary completion date • Metastases
|
Keytruda (pembrolizumab) • Ampligen (rintatolimod) • Bioferon (interferon alpha 2b) • celecoxib oral
8ms
Rintatolimod in Advanced Pancreatic Cancer enhances Anti-Tumor Immunity through Dendritic Cell-Mediated T Cell Responses. (PubMed, Clin Cancer Res)
This study presents compelling evidence of the immune-stimulatory properties linked to TLR-3 activation through rintatolimod. Rintatolimod may break immunological tolerance by enhancing anti-tumor immunity through DC-mediated Th-cell responses. Furthermore, our findings lay the groundwork for investigating the potential synergy between TLR-3 activation and immune checkpoint inhibitor therapy to improve therapeutic outcomes.
Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
|
PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • PD-L2 (Programmed Cell Death 1 Ligand 2) • IDO1 (Indoleamine 2,3-dioxygenase 1) • CD4 (CD4 Molecule) • BTLA (B And T Lymphocyte Associated) • TLR3 (Toll Like Receptor 3)
|
PD-L2 expression
|
Ampligen (rintatolimod)
9ms
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, Suspended, Roswell Park Cancer Institute | Trial completion date: Nov 2024 --> May 2024 | Trial primary completion date: Nov 2023 --> May 2024
Trial completion date • Trial primary completion date • Surgery
|
Intron A (interferon α-2b) • Ampligen (rintatolimod) • aspirin
10ms
Enrollment open
|
PD-L1 expression • PD-L1 negative
|
Keytruda (pembrolizumab) • Ampligen (rintatolimod) • Bioferon (interferon alpha 2b) • celecoxib oral
10ms
Enrollment open
|
CD8 (cluster of differentiation 8)
|
CD8 positive
|
Intron A (interferon α-2b) • Ampligen (rintatolimod) • aDC1 vaccine • celecoxib oral
10ms
Study to Evaluate the Efficacy and Safety of Ampligen in Patients With Post-COVID Conditions (clinicaltrials.gov)
P2, N=80, Completed, AIM ImmunoTech Inc. | Active, not recruiting --> Completed
Trial completion
|
Ampligen (rintatolimod)
1year
Systemic infusion of TLR3-ligand and IFN-α in patients with breast cancer reprograms local tumor microenvironments for selective CTL influx. (PubMed, J Immunother Cancer)
Short-term systemic CKM selectively increases CTL numbers and CTL/Treg ratios in the TME, while transiently decreasing CTL numbers in the blood. Transient effects of CKM suggest that its simultaneous application with checkpoint blockade and other forms of immunotherapy may be needed for optimal outcomes.
Journal • PD(L)-1 Biomarker • IO biomarker
|
CD8 (cluster of differentiation 8) • CXCL10 (Chemokine (C-X-C motif) ligand 10) • CXCL12 (C-X-C Motif Chemokine Ligand 12) • CCL2 (Chemokine (C-C motif) ligand 2) • GZMB (Granzyme B) • FOXP3 (Forkhead Box P3) • TLR3 (Toll Like Receptor 3) • CCL22 (C-C Motif Chemokine Ligand 22) • CXCR3 (C-X-C Motif Chemokine Receptor 3) • HPRT1 (Hypoxanthine Phosphoribosyltransferase 1) • IFNA1 (Interferon Alpha 1)
|
CD8 expression • FOXP3 expression
|
Keytruda (pembrolizumab) • Ampligen (rintatolimod) • celecoxib oral
1year
Chemokine-modulating regimen (rintatolimod, IFN-α2b, celecoxib): New strategy to drive CD8+T-cells into triple negative breast cancer . (SABCS 2023)
Combination of NAC with pembrolizumab, the new standard of care in TNBC, increases the pCR rate to 65% but is associated with significant and often permanent immune-related toxicities...We hypothesized that the combination of CKM with paclitaxel-based NAC will promote selective CTL infiltration into TNBC, and along with doxorubicin/cyclophosphamide (AC), will result in higher rate of pCR, translating into improved RFS and OS... We have observed preliminary indications of safety and good tolerability of the combination of CKM regimen with paclitaxel, with promising pCR + ypTmic of 66%. RNA sequencing indicates that CKM may drive CD8+ T cells from the blood into the tumor.
PD(L)-1 Biomarker
|
CD8 (cluster of differentiation 8) • CXCL10 (Chemokine (C-X-C motif) ligand 10) • CXCL9 (Chemokine (C-X-C motif) ligand 9) • CXCL11 (C-X-C Motif Chemokine Ligand 11) • CCL2 (Chemokine (C-C motif) ligand 2) • CCL22 (C-C Motif Chemokine Ligand 22) • IFNA1 (Interferon Alpha 1)
|
Keytruda (pembrolizumab) • paclitaxel • doxorubicin hydrochloride • cyclophosphamide • Ampligen (rintatolimod) • celecoxib oral
1year
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=12, Not yet recruiting, Roswell Park Cancer Institute | Trial completion date: Jun 2025 --> Dec 2025 | Initiation date: Sep 2023 --> Dec 2023 | Trial primary completion date: Jun 2025 --> Dec 2025
Trial completion date • Trial initiation date • Trial primary completion date • Metastases
|
PD-L1 expression • PD-L1 negative
|
Keytruda (pembrolizumab) • Ampligen (rintatolimod) • Bioferon (interferon alpha 2b) • celecoxib oral
1year
Trial initiation date • Checkpoint inhibition • Metastases
|
CD8 (cluster of differentiation 8)
|
Imfinzi (durvalumab) • Ampligen (rintatolimod)
over1year
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=12, Not yet recruiting, Roswell Park Cancer Institute | Trial completion date: Jul 2027 --> Jun 2025 | Trial primary completion date: Jul 2026 --> Jun 2025
Trial completion date • Trial primary completion date • Metastases
|
PD-L1 expression • PD-L1 negative
|
Keytruda (pembrolizumab) • Ampligen (rintatolimod) • Bioferon (interferon alpha 2b) • celecoxib oral
over1year
Trial completion • Metastases
|
Keytruda (pembrolizumab) • Intron A (interferon α-2b) • Ampligen (rintatolimod)
over1year
Rintatolimod: a potential treatment in patients with pancreatic cancer expressing Toll-like receptor 3. (PubMed, Am J Cancer Res)
Lastly, we identified fifteen genes, altered with a Log FOC > |1.0| in rintatolimod-treated CFPAC-1 cells, which were significantly related to three transcription factors (NFKB1, RELA, and SP1) regulating the TLR-3 signaling pathway. In conclusion, we propose that rintatolimod treatment might have a direct TLR-3-dependent anti-tumoral effect on pancreatic cancer cells expressing TLR-3.
Journal • IO biomarker
|
TLR3 (Toll Like Receptor 3) • RELA (RELA Proto-Oncogene)
|
Ampligen (rintatolimod)
over1year
New P1/2 trial • Checkpoint inhibition • Metastases
|
CD8 (cluster of differentiation 8)
|
Imfinzi (durvalumab) • Ampligen (rintatolimod)
over1year
IMMUNE RESPONSE IN STABLE PANCREATIC CANCER AFTER RINTATOLIMOD TREATMENT (APCM 2023)
Treatment of patients with locally advanced pancreatic cancer after FOLFIRINOX with rintatolimod may induce markers of dendritic cells and T cells in a subgroup of patients. The absence of these markers could predict tumor progression after FOLFIRINOX. Further identification of T lymphocyte and dendritic cell subsets using flow-cytometry analysis will be presented.
PD(L)-1 Biomarker • IO biomarker
|
CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • LAG3 (Lymphocyte Activating 3) • CD123 (Interleukin 3 Receptor Subunit Alpha) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • CD4 (CD4 Molecule) • ICOS (Inducible T Cell Costimulator) • CCR7 (Chemokine (C-C motif) receptor 7) • CD27 (CD27 Molecule) • GZMB (Granzyme B) • IRF4 (Interferon regulatory factor 4) • CD1C (CD1c Molecule)
|
5-fluorouracil • irinotecan • leucovorin calcium • Ampligen (rintatolimod)
over1year
Trial initiation date • Metastases
|
5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • Ampligen (rintatolimod)
over1year
Chemokine Modulation Therapy and Standard Chemotherapy Before Surgery for the Treatment of Early Stage Triple Negative Breast Cancer (clinicaltrials.gov)
P1, N=9, Completed, Roswell Park Cancer Institute | Active, not recruiting --> Completed | Trial completion date: Feb 2024 --> Feb 2023
Trial completion • Trial completion date • Surgery
|
PGR (Progesterone receptor) • CD8 (cluster of differentiation 8)
|
ER positive + PGR positive • PGR positive
|
paclitaxel • doxorubicin hydrochloride • cyclophosphamide • daunorubicin • Intron A (interferon α-2b) • Ampligen (rintatolimod)
over1year
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=12, Not yet recruiting, Roswell Park Cancer Institute | Trial completion date: Apr 2027 --> Jul 2027 | Trial primary completion date: Apr 2026 --> Jul 2026
Trial completion date • Trial primary completion date • Metastases
|
PD-L1 expression • PD-L1 negative
|
Keytruda (pembrolizumab) • Ampligen (rintatolimod) • Bioferon (interferon alpha 2b) • celecoxib oral
over1year
Chemokine Modulation Therapy and Standard Chemotherapy Before Surgery for the Treatment of Early Stage Triple Negative Breast Cancer (clinicaltrials.gov)
P1, N=9, Active, not recruiting, Roswell Park Cancer Institute | Suspended --> Active, not recruiting | N=24 --> 9 | Trial completion date: May 2023 --> Feb 2024
Enrollment closed • Enrollment change • Trial completion date • Surgery
|
PGR (Progesterone receptor) • CD8 (cluster of differentiation 8)
|
ER positive + PGR positive • PGR positive
|
paclitaxel • doxorubicin hydrochloride • cyclophosphamide • daunorubicin • Intron A (interferon α-2b) • Ampligen (rintatolimod)
over1year
Rintatolimod and IFN Alpha-2b for the Treatment of COVID-19 in Cancer Patients (clinicaltrials.gov)
P1/2, N=64, Suspended, Roswell Park Cancer Institute | Recruiting --> Suspended
Trial suspension
|
CRP (C-reactive protein)
|
Intron A (interferon α-2b) • Ampligen (rintatolimod)
2years
Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines (clinicaltrials.gov)
P1/2, N=25, Suspended, Roswell Park Cancer Institute | Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Dec 2024 --> Dec 2025
Trial completion date • Trial primary completion date
|
CD4 (CD4 Molecule)
|
cisplatin • Ampligen (rintatolimod) • aDC1 vaccine • celecoxib oral
2years
Preliminary indications of safety and efficacy of neoadjuvant chemotherapy plus chemokine-modulating regimen (rintatolimod, IFN-α2b, celecoxib) in triple negative breast cancer (SABCS 2022)
We hypothesized that the combination of CKM with paclitaxel will promote selective CTL infiltration into TNBC, and along with doxorubicin/cyclophosphamide (AC), will result in higher rate of pCR, translating into improved RFS and OS. The treatment was well-tolerated and no DLTs were observed and we determined RP2D for future studies. We observed promising clinical activity with pCR + ypTmic rate of 66%, comparable to pembrolizumab combination with NAC. A larger phase II study is being designed to confirm the observed efficacy and to determine if CKM regimen would be a safer short-term alternative to pembrolizumab or if CKM can overcome the resistance to the standard pembrolizumab/NAC therapy.
Clinical • PD(L)-1 Biomarker
|
CD8 (cluster of differentiation 8) • CXCL10 (Chemokine (C-X-C motif) ligand 10) • CXCL9 (Chemokine (C-X-C motif) ligand 9) • CXCL11 (C-X-C Motif Chemokine Ligand 11) • CCL2 (Chemokine (C-C motif) ligand 2) • CCL22 (C-C Motif Chemokine Ligand 22) • IFNA1 (Interferon Alpha 1)
|
CXCL9 expression • CXCL9 overexpression
|
Keytruda (pembrolizumab) • paclitaxel • doxorubicin hydrochloride • cyclophosphamide • Ampligen (rintatolimod) • celecoxib oral
2years
Safety and efficacy of de-escalated neoadjuvant chemoimmunotherapy of triple negative breast cancer (TNBC) using chemokine-modulating regimen (rintatolimod, IFN-α2b, celecoxib) (SITC 2022)
CKM/Paclitaxel was followed by standard dose-dense doxorubicin and cyclophosphamide (AC) and surgery. Conclusions The treatment was well tolerated, with promising clinical activity of pCR + ypTmic at 66%, comparable to pembrolizumab/NAC. Upcoming phase II study in early stage TNBC is planned to determine if CKM can be used as an alternative to pembrolizumab or to overcome pembrolizumab/NAC resistance.
Clinical • PD(L)-1 Biomarker • IO biomarker
|
CD8 (cluster of differentiation 8) • CXCL10 (Chemokine (C-X-C motif) ligand 10) • CXCL9 (Chemokine (C-X-C motif) ligand 9) • CXCL11 (C-X-C Motif Chemokine Ligand 11) • IFNA1 (Interferon Alpha 1)
|
Keytruda (pembrolizumab) • paclitaxel • doxorubicin hydrochloride • cyclophosphamide • Ampligen (rintatolimod) • celecoxib oral
2years
Chemokine Modulation Therapy and Standard Chemotherapy Before Surgery for the Treatment of Early Stage Triple Negative Breast Cancer (clinicaltrials.gov)
P1, N=24, Suspended, Roswell Park Cancer Institute | Trial primary completion date: Aug 2022 --> May 2022
Trial primary completion date • Surgery
|
PGR (Progesterone receptor) • CD8 (cluster of differentiation 8)
|
ER positive + PGR positive • PGR positive
|
paclitaxel • doxorubicin hydrochloride • cyclophosphamide • daunorubicin • Intron A (interferon α-2b) • Ampligen (rintatolimod)
over2years
Trial suspension
|
PGR (Progesterone receptor) • CD8 (cluster of differentiation 8)
|
ER positive + PGR positive • PGR positive
|
paclitaxel • doxorubicin hydrochloride • cyclophosphamide • daunorubicin • Intron A (interferon α-2b) • Ampligen (rintatolimod)
over2years
Combined loco-regional and systemic, triple agent chemoimmunotherapy increases biomarkers of T cell chemotaxis in ovarian cancer (AACR 2022)
We hypothesize that a combination of intraperitoneal (IP) chemotherapy (cisplatin) with dual agent immunotherapy using intravenous (IV) pembrolizumab (anti-PD1) and IP rintatolimod (TLR-3 agonist) will help overcome immune suppressive mechanisms for improved tumor response by promoting increased T cell chemotaxis and cytolytic function. To test our hypothesis, we are running an investigator initiated, phase II, single arm, efficacy/safety trial (NCT03734692). In this ongoing Phase II study, a total of 17 patients were enrolled and 13 were evaluable for response. The observed clinical responses were: 2 complete responses (15.4%), 3 partial responses (23.1%), 3 stable disease (23.1%), 5 progressions (38.4%) for an clinical benefit rate (CR+PR+SD) of 61.6%. From 13 patients, 7 IP wash samples were collected at serial time points.
PD(L)-1 Biomarker • IO biomarker
|
TNFA (Tumor Necrosis Factor-Alpha) • CXCL10 (Chemokine (C-X-C motif) ligand 10) • CXCL12 (C-X-C Motif Chemokine Ligand 12) • CXCL9 (Chemokine (C-X-C motif) ligand 9) • CXCL11 (C-X-C Motif Chemokine Ligand 11) • GZMB (Granzyme B) • CXCR3 (C-X-C Motif Chemokine Receptor 3)
|
Keytruda (pembrolizumab) • cisplatin • Ampligen (rintatolimod)
over2years
Negative impact of paclitaxel on human breast tumor microenvironment and its reversal by the combination of interferon-α with TLR3 agonist rintatolimod (AACR 2022)
Our results identify an undesirable aspect of paclitaxel’s impact on breast cancer. The ability of CKM to enhance the expression of CTL/NK cell attractants and suppress the production of Treg/MDSC attractants produced by paclitaxel provides a strong rationale for combined use of CKM in taxane-based chemo-immunotherapy of breast cancer and potentially other diseases.
IO biomarker
|
CXCL8 (Chemokine (C-X-C motif) ligand 8) • CXCL10 (Chemokine (C-X-C motif) ligand 10) • CXCL12 (C-X-C Motif Chemokine Ligand 12) • CXCL9 (Chemokine (C-X-C motif) ligand 9) • CXCL11 (C-X-C Motif Chemokine Ligand 11) • CCL2 (Chemokine (C-C motif) ligand 2) • CCL22 (C-C Motif Chemokine Ligand 22) • CXCR3 (C-X-C Motif Chemokine Receptor 3)
|
paclitaxel • Ampligen (rintatolimod)
almost3years
Phase I trial combining chemokine-targeting with loco-regional chemo-immunotherapy for recurrent, platinum-sensitive ovarian cancer shows induction of CXCR3 ligands and markers of type 1 immunity. (PubMed, Clin Cancer Res)
The chemokine-modulating IP-CITC is safe, tolerable, and associated with ISG changes that favor CTL chemoattraction and function. This combination (plus DC vaccine) will be tested in a phase II trial.
P1 data • Journal • IO biomarker
|
CXCL9 (Chemokine (C-X-C motif) ligand 9) • TLR3 (Toll Like Receptor 3) • CXCR3 (C-X-C Motif Chemokine Receptor 3)
|
cisplatin • Ampligen (rintatolimod) • celecoxib oral
almost3years
Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines (clinicaltrials.gov)
P1/2, N=25, Suspended, Roswell Park Cancer Institute | Trial completion date: Sep 2023 --> Jun 2025 | Trial primary completion date: May 2023 --> Dec 2024
Clinical • Trial completion date • Trial primary completion date
|
CD4 (CD4 Molecule)
|
cisplatin • Ampligen (rintatolimod) • celecoxib oral
almost3years
Rintatolimod and IFN Alpha-2b for the Treatment of COVID-19 in Cancer Patients (clinicaltrials.gov)
P1/2, N=64, Recruiting, Roswell Park Cancer Institute | Trial completion date: Nov 2022 --> Nov 2023 | Trial primary completion date: Nov 2021 --> Nov 2023
Trial completion date • Trial primary completion date
|
CRP (C-reactive protein)
|
Intron A (interferon α-2b) • Ampligen (rintatolimod)
3years
A Clinical Trial of Autologous Oxidized Tumor Cell Lysate Vaccine For Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer (clinicaltrials.gov)
P1/2, N=3, Terminated, Abramson Cancer Center of the University of Pennsylvania | Completed --> Terminated; Did not meet criteria laid out in Phase 1 to continue to Phase 2
Clinical • Trial termination
|
HER-2 (Human epidermal growth factor receptor 2) • IFNG (Interferon, gamma)
|
Ampligen (rintatolimod)
3years
Celecoxib, Recombinant Interferon Alfa-2b, and Rintatolimod in Treating Patients With Colorectal Cancer Metastatic to the Liver (clinicaltrials.gov)
P2a, N=15, Completed, Roswell Park Cancer Institute | Active, not recruiting --> Completed | Trial completion date: Nov 2021 --> Aug 2021
Clinical • Trial completion • Trial completion date
|
PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
|
MSI-H/dMMR • RAS wild-type
|
Intron A (interferon α-2b) • Ampligen (rintatolimod) • celecoxib oral
3years
Rintatolimod and IFN Alpha-2b for the Treatment of COVID-19 in Cancer Patients (clinicaltrials.gov)
P1/2, N=64, Recruiting, Roswell Park Cancer Institute | Trial completion date: Apr 2022 --> Nov 2022
Clinical • Trial completion date
|
CRP (C-reactive protein)
|
Intron A (interferon α-2b) • Ampligen (rintatolimod)