A Phase 2 Randomized Open-Label Controlled Study to Evaluate the Efficacy and Safety of Ampligen in Combination With Standard of Care Versus SOC Alone Following First-Line Therapy in Subjects With Locally Advanced Pancreatic Adenocarcinoma

The purpose of this study is to assess the safety and efficacy of Ampligen in patients with locally advanced pancreatic adenocarcinoma

Start Date01 Jul 2025

Sponsor / Collaborator

AIM ImmunoTech, Inc.

[+1]

NCT04093323

/ TerminatedPhase 2IIT

A Phase II Study of Type-1 Polarized Dendritic Cell (aDC1) -Based Treatment in Combination With Tumor-Selective Chemokine Modulation (CKM: Interferon Alpha 2b, Rintatolimod and Celecoxib) in Melanoma Patients With Primary PD-1/PD-L1 Resistance

This phase II trial studies how well polarized dendritic cell (aDC1) based therapy, interferon alpha-2, rintatolimod, and celecoxib work together in treating patients with HLA-A2 positive (+) melanoma that has not responded to previous treatment (refractory). The aDC1 cell-based treatment contains white blood cells (dendritic cells or DCs) that stimulates the immune system. Interferon alpha-2 can improve the body's natural response to infections and other diseases. It can also interfere with the division of cancer cells and slow tumor growth. Rintalolimid may stimulate the immune system. Celecoxib is a drug that reduces pain. This study is being done to find out if the combination of the study cell-based treatment (aDC1 dendritic cells) and interferon alpha-2, rintatolimod, and celecoxib can prevent the growth and/or progression of melanoma.

Start Date13 Nov 2024

Sponsor / Collaborator

Roswell Park Comprehensive Cancer Center

[+1]

NCT05756166

/ TerminatedPhase 1/2IIT

Phase I/IIa Clinical Trial Evaluating the Safety and Efficacy of Rintatolimod Combined With IFNα2b (Bioferon®) to Enhance the Effectiveness of Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer

This phase I/IIa trial tests the safety, side effects, and best dose of chemokine modulation therapy (CKM) (rintatolimod, celecoxib, and interferon alpha 2b) in combination with pembrolizumab for the treatment of patients with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). CKM drugs such as rintatolimod and interferon alpha 2b work to modify the immune response and tumor-related processes, including tumor cell growth, blood vessel growth, and metastasis. Celecoxib is an anti-inflammatory drug that can cause cell death and may reduce the growth of blood vessels tumors need to grow and spread. Immunotherapy such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving CKM therapy prior to pembrolizumab may direct the immune cells to the cancer cells and maximize the effectiveness of pembrolizumab in patients with metastatic or unresectable triple negative breast cancer.

Start Date16 Feb 2024

Sponsor / Collaborator

Roswell Park Comprehensive Cancer Center

[+1]

100 Clinical Results associated with Rintatolimod

100 Translational Medicine associated with Rintatolimod

100 Patents (Medical) associated with Rintatolimod

Literatures (Medical) associated with Rintatolimod

01 Nov 2024·Journal for ImmunoTherapy of Cancer

Systemic chemokine-modulatory regimen combined with neoadjuvant chemotherapy in patients with triple-negative breast cancer

Article

Author: Attwood, Kristopher ; Wang, Jianming ; Gnjatic, Sacha ; Ioannou, Giorgio ; De Souza, Igor ; Fitzpatrick, Victoria ; Kumar, Prasanna ; Miller, Janine ; Janes, Cayla ; Kalinski, Pawel ; Kokolus, Kathleen M ; Gandhi, Shipra ; Young, Jessica ; Opyrchal, Mateusz ; O'Connor, Tracey ; O’Connor, Tracey ; Roudko, Vladimir ; Slomba, Ronald T ; Levine, Ellis G ; Cortes Gomez, Eduardo ; Kalathil, Suresh ; Cappuccino, Helen ; Ozbey, Sinem ; Takabe, Kazuaki ; Edge, Stephen

Background:

Higher cytotoxic T lymphocyte (CTL) numbers in the tumor microenvironment (TME) predict pathologic complete response (pCR) to neoadjuvant chemotherapy (NAC) and positive long-term outcomes in triple-negative breast cancer (TNBC). pCR to NAC is achieved only in 30–40% of patients. The combination of NAC with pembrolizumab increases the pCR rate but at the cost of immune-related adverse events (irAEs). Based on these considerations, we tested if systemic infusion of the chemokine modulatory regimen (CKM; selective toll-like receptor 3 (TLR3) agonist rintatolimod, interferon (IFN)-α2b, and cyclooxygenase-2 (COX-2) inhibitor celecoxib) regimen can be safely combined with NAC to enhance intratumoral CTL numbers and NAC effectiveness.

Methods:

Phase I studyNCT04081389evaluated nine patients with early-stage TNBC who received 3 weeks of paclitaxel with CKM (dose-escalation of IFN-α2b), followed by 9 weeks of paclitaxel alone, dose-dense doxorubicin and cyclophosphamide, and surgery. Primary and secondary endpoints were safety and clinical efficacy, respectively.

Results:

The combination treatment was well-tolerated with no dose-limiting toxicities or irAEs. 5/9 patients achieved pCR and one patient had microinvasive disease (ypTmic). We observed elevated IFN signature and uniform decreases in CTL numbers (average 8.3-fold) in the blood of all treated patients. This was accompanied by reciprocal uniform increases in CD8β (overall 5.9-fold), CD8α/FoxP3 (2.11-fold), and CCL5 (4.73-fold) transcripts in TME, particularly pronounced in patients with pCR. Multiplex immunohistochemistry revealed selectively increased numbers of CTL (but not regulatory T cells) in both the epithelial and stromal tumor compartments and early decreases in the numbers of αSMA+vascular/stromal cells in the tumors of all pCR patients.

Conclusions:

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.

15 Aug 2024·Clinical cancer research : an official journal of the American Association for Cancer Research

Rintatolimod in Advanced Pancreatic Cancer Enhances Antitumor Immunity through Dendritic Cell–Mediated T-Cell Responses

Article

Author: van Eijck, Casper H.J. ; van Eijck, Casper W.F. ; Mustafa, Dana A.M. ; Aerts, Joachim G.J.V. ; Kucukcelebi, Songul ; Willemsen, Marcella ; Fellah, Amine ; Vadgama, Disha ; Haddaoui, Hassana el

Abstract:

Purpose::

Amid the need for new approaches to improve survival in pancreatic ductal adenocarcinoma (PDAC), immune-based therapies have garnered interest. Rintatolimod, a Toll-like receptor 3 (TLR-3) agonist, is a potential candidate due to its dual impact on restraining PDAC cell functions and boosting the antitumor immune response. This study investigates the effect of TLR-3 activation through rintatolimod on the peripheral immune landscape of patients with advanced PDAC.

Experimental Design::

Paired blood samples of 30 patients with advanced PDAC, collected at baseline and after 12 rintatolimod intravenous infusions, underwent comprehensive transcriptomic NanoString and proteomic flow cytometry profiling. The impact of rintatolimod and immunologic factors on survival outcomes was assessed through univariate Cox proportional hazards models.

Results::

Rintatolimod treatment enhances peripheral immune activity at the transcriptomic and proteomic levels, particularly involving type 1 conventional dendritic cells (cDC1) and T cells. Post-rintatolimod, the increased peripheral abundance of BTLA+ XCR1+ cDC1s and CD4+SELL+ T cells correlated with improved clinical outcomes. Patients with stable disease exhibited pronouncedDCand T-cell activation gene overexpression. Notably, the expression of immune checkpoints PD-L1 and PD-L2 decreased post-rintatolimod across all patients. However, those with progressive disease showed increased expression of genes encoding IDO1 and PD-1.

Conclusions::

This study presents compelling evidence of the immune-stimulatory properties linked to TLR-3 activation through rintatolimod. Rintatolimod may break immunologic tolerance by enhancing antitumor 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.See related commentary by Martínez-Riaño et al., p. 3355

01 Nov 2023·Journal for immunotherapy of cancer

Systemic infusion of TLR3-ligand and IFN-α in patients with breast cancer reprograms local tumor microenvironments for selective CTL influx

Article

Author: Kokolus, Kathleen M ; Attwood, Kristopher ; Wallace, Paul K ; Grimm, Melissa J ; Slomba, Ronald T ; Witkiewicz, Agnieszka ; O'Connor, Tracey L ; Minderman, Hans ; Williams, Lauren ; Groman, Adrienne ; Levine, Ellis G ; Kalinski, Pawel ; Soh, Kah Teong ; Early, Amy P ; Maguire, Orla ; Opyrchal, Mateusz ; Gandhi, Shipra ; Tarquini, Mary Lynne

Background:

Presence of cytotoxic T lymphocytes (CTL) in the tumor microenvironment (TME) predicts the effectiveness of cancer immunotherapies. The ability of toll-like receptor 3 (TLR3) ligands, interferons (IFNs) and COX2 inhibitors to synergistically induce CTL-attracting chemokines (but not regulatory T cell (Treg)-attractants) in the TME, but not in healthy tissues, observed in our preclinical studies, suggested that their systemic application can reprogram local TMEs.

Methods:

Six evaluable patients (33–69 years) with metastatic triple-negative breast cancer received six doses of systemic chemokine-modulating (CKM) regimen composed of TLR3 ligand (rintatolimod; 200 mg; intravenous), IFN-α2b (20 MU/m2; intravenous) and COX2 inhibitor (celecoxib; 2×200 mg; oral) over 2 weeks. The predetermined primary endpoint was the intratumoral change in the expression of CTL marker, CD8α, in the post-CKM versus pre-CKM tumor biopsies. Patients received follow-up pembrolizumab (200 mg, intravenously, every 3 weeks), starting 3–8 days after completion of CKM.

Results:

Post-CKM biopsies showed selectively increased CTL markers CD8α (average 10.2-fold, median 5.5-fold, p=0.034) and granzyme B (GZMB; 6.1-fold, median 5.8-fold, p=0.02), but not FOXP3 (Treg marker) relative to HPRT1 expression, resulting in the increases in average CD8α/FOXP3 ratio and GZMB/FOXP3 ratio. CKM increased intratumoral CTL-attractants CCL5 and CXCL10, but not Treg-attractants CCL22 or CXCL12. In contrast, CD8+T cells and their CXCR3+subset showed transient decreases in blood. One clinical response (breast tumor autoamputation) and three stable diseases were observed. The patient with clinical response remains disease free, with a follow-up of 46 months as of data cut-off.

Conclusions:

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.

151

News (Medical) associated with Rintatolimod

31 Jul 2025

·www.globenewswire.com

AIM ImmunoTech Announces Closing of $8.0 Million Public Offering

OCALA, Fla., July 31, 2025 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (the “Company”), today announced the closing of its previously announced public offering of an aggregate of 2,000,000 shares of its common stock (or pre-funded warrants in lieu thereof), Class E warrants to purchase up to 2,000,000 shares of common stock, and Class F warrants to purchase up to 2,000,000 shares of common stock, at a combined public offering price of $4.00 per share (or $3.999 per pre-funded warrant) and accompanying warrants. The warrants have an exercise price of $4.00 per share, and were exercisable immediately upon issuance. The Class E warrants will expire on the fifth anniversary of the original issuance date, and the Class F warrants will expire on the eighteen-month anniversary of the original issuance date. Gross proceeds, before deducting placement agent fees and offering expenses, were approximately $8.0 million. Maxim Group LLC acted as sole placement agent in connection with this offering. The securities described above were being offered pursuant to a registration statement on Form S-1, as amended (File No. 333-284443) (the “Registration Statement”), which was declared effective by the Securities and Exchange Commission (the "SEC") on July 28, 2025. Copies of the final prospectus relating to this offering have been filed with the SEC and may be obtained from Maxim Group LLC, 300 Park Avenue, 16th Floor, New York, NY 10022, at (212) 895-3745. About AIM ImmunoTech Inc. AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19. The Company’s lead product is a first-in-class investigational drug called Ampligen® (rintatolimod), a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system. For more information, please visit aimimmuno.com and connect with the Company on X, LinkedIn, and Facebook. Cautionary Statement This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “continue,” “believe,” “potential,” “upcoming” and other variations thereon and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. The Company urges investors to consider specifically the various risk factors identified in the Registration Statement, the Company’s most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Among other things, for those statements, the Company claims the protection of the safe harbor for forward-looking statements contained in the PSLRA. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Investor Contact: JTC Team, LLC Jenene Thomas (908) 824-0775 AIM@jtcir.com

Immunotherapy

29 Jul 2025

·www.globenewswire.com

AIM ImmunoTech Reports Positive Mid-year Safety and Efficacy Data from Phase 2 Study Evaluating Ampligen® (rintatolimod) in Combination with AstraZeneca’s Imfinzi® (durvalumab) for the Treatment of Pancreatic Cancer

July 28, 2025 -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today reported positive data in a mid-year update from the ongoing Phase 2 clinical study evaluating AIM’s drug Ampligen® (rintatolimod) combined with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX (the “DURIPANC” study) (See: ClinicalTrials.gov NCT05927142). The DURIPANC study — which is a joint collaboration with AstraZeneca and Erasmus Medical Center (“Erasmus MC”) in the Netherlands — is an investigator-initiated, exploratory, open-label, single-center study expected to enroll up to 25 subjects in the Phase 2 portion. A total of 14 subjects have been enrolled in DURIPANC as of the mid-year report. The primary objective of the study is the clinical benefit rate of the combination therapy; the secondary/exploratory objectives include assessing overall survival (OS), progression-free survival (PFS) and initiating immune-monitoring using available tissue biopsies and peripheral immune profiling. Prof. Casper van Eijck, MD, PhD, of Erasmus MC, stated: “Our preliminary data suggests that the combination of Ampligen and durvalumab is well-tolerated in post-FOLFIRINOX pancreatic cancer patients, with encouraging preliminary survival data, especially given the historical difficulty of improving outcomes in this setting. Immunologic correlatives and further follow-up are essential to determine the biological activity and the durability of response. In addition, it will be important to identify which patients are most likely to benefit from the combination treatment, thereby personalizing therapy better and maximizing clinical outcomes.” Pancreatic cancer has limited immunotherapy responsiveness, particularly in unselected populations. Following FOLFIRINOX, maintenance or second-line immunotherapies have historically shown limited survival benefit in comparison trials. Compared to these data, the DURIPANC study mid-year report shows continuing promising early signs of both no significant toxicity and superior PFS and OS: No significant toxicity, an encouraging safety profile for a post-chemo setting; ~21% of patients have PFS >6 months (3/14), with an additional 21% not yet progressed; and OS >6 months in the majority (64%) of eligible patients—better than expected in this setting. AIM ImmunoTech CEO Thomas K. Equels stated: “Data from Ampligen as a maintenance monotherapy was extremely positive when compared to existing therapeutic approaches. DURIPANC builds on that foundation and these results suggest a clear path forward and identify a promising potential benefit of combining the selective innate immune activation of Ampligen with the checkpoint inhibition of durvalumab in pancreatic cancer maintenance therapy. I am hopeful that pending immune-monitoring data analysis by Prof. van Eijck and the team at Erasmus Medical Center will identify additional mechanistic insights or predictive biomarkers in this potentially groundbreaking clinical trial, bringing hope for a future therapy for this highly lethal and clearly unmet medical need that kills more than 100,000 people in the American and European Union markets each year, and more than 500,000 worldwide.” The DURIPANC study is the culmination of several years of focus by AIM on the development of Ampligen for the treatment of pancreatic cancer. Since 2017, more than 50 pancreatic cancer patients received treatment with Ampligen as an immuno-oncology mono-therapy under a Dutch government-approved Compassionate Use/Early Access Program at Erasmus MC. Prof. van Eijck was the lead investigator and the EAP has produced a number of detailed analyses in both abstracts and peer-reviewed medical research publications: Rintatolimod (Ampligen®) Enhances Numbers of Peripheral B Cells and Is Associated with Longer Survival in Patients with Locally Advanced and Metastasized Pancreatic Cancer Pre-Treated with FOLFIRINOX: A Single-Center Named Patient Program Treating Pancreatic Ductal Adenocarcinoma Patients with Rintatolimod: Hitting Two Targets with One Arrow? Rintatolimod in Advanced Pancreatic Cancer Enhances Antitumor Immunity through Dendritic Cell-Mediated T-Cell Responses Based on these strong results suggesting Ampligen’s potential effectiveness as a pancreatic cancer monotherapy, in January 2023 the Company entered into Clinical Agreements with AstraZeneca and Erasmus MC for the investigator-initiated DURIPANC clinical trial to study the potential combination therapy of Ampligen and Durvalumab, a PD-L1 checkpoint inhibitor. In order to protect what has the potential to be a valuable long-term benefit for stockholders, AIM has developed an intellectual property plan specific to pancreatic cancer that includes a recently issued U.S. patent for Ampligen as an oncology treatment in combination with an anti-PD-L1, extending protection to August 9, 2039, as well as orphan drug designations in pancreatic cancer in both the United States and the European Union granting years of market exclusivity to AIM for Ampligen post-commercial approval. AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19. The Company’s lead product is a first-in-class investigational drug called Ampligen® (rintatolimod), a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system. The content above comes from the network. if any infringement, please contact us to modify.

ImmunotherapyClinical ResultOrphan Drug

29 Jul 2025

·www.globenewswire.com

AIM ImmunoTech Announces Pricing of $8.0 Million Public Offering

OCALA, Fla., July 29, 2025 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (the “Company”), today announced the pricing of a public offering of an aggregate of 2,000,000 shares of its common stock (or pre-funded warrants in lieu thereof), Class E warrants to purchase up to 2,000,000 shares of common stock, and Class F warrants to purchase up to 2,000,000 shares of common stock, at a combined public offering price of $4.00 per share (or $3.999 per pre-funded warrant) and accompanying warrants. The warrants will have an exercise price of $4.00 per share, will be exercisable immediately upon issuance. The Class E warrants will expire on the fifth anniversary of the original issuance date, and the Class F warrants will expire on the eighteen-month anniversary of the original issuance date. The closing of the offering is expected to occur on or about July 30, 2025, subject to the satisfaction of customary closing conditions. Gross proceeds, before deducting placement agent fees and offering expenses, are expected to be approximately $8.0 million. Maxim Group LLC is acting as sole placement agent in connection with this offering. The securities described above are being offered pursuant to a registration statement on Form S-1, as amended (File No. 333-284443) (the “Registration Statement”), which was declared effective by the Securities and Exchange Commission (the "SEC") on July 28, 2025. The offering is being made only by means of a prospectus which is a part of the effective Registration Statement. A preliminary prospectus relating to the offering has been filed with the SEC. Copies of the final prospectus relating to this offering, when available, will be filed with the SEC and may be obtained from Maxim Group LLC, 300 Park Avenue, 16th Floor, New York, NY 10022, at (212) 895-3745. This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. About AIM ImmunoTech Inc. AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19. The Company’s lead product is a first-in-class investigational drug called Ampligen® (rintatolimod), a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system. For more information, please visit aimimmuno.com and connect with the Company on X, LinkedIn, and Facebook. Cautionary Statement This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “continue,” “believe,” “potential,” “upcoming” and other variations thereon and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. The Company urges investors to consider specifically the various risk factors identified in the Registration Statement, the Company’s most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Among other things, for those statements, the Company claims the protection of the safe harbor for forward-looking statements contained in the PSLRA. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Investor Contact: JTC Team, LLC Jenene Thomas (833) 475-8247 AIM@jtcir.com

Immunotherapy

100 Deals associated with Rintatolimod

External Link

KEGG	Wiki	ATC	Drug Bank
D09661	Rintatolimod	L03A	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Fatigue Syndrome, Chronic	Argentina	AIM ImmunoTech, Inc.	01 Jan 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Pancreatic Adenocarcinoma	Phase 2	United States	AIM ImmunoTech, Inc.	01 Jul 2025
Metastatic Pancreatic Cancer	Phase 2	Netherlands	AstraZeneca PLC	09 Jan 2024
Metastatic Pancreatic Cancer	Phase 2	Netherlands	AIM ImmunoTech, Inc.	09 Jan 2024
Metastatic Pancreatic Ductal Adenocarcinoma	Phase 2	Netherlands	AIM ImmunoTech, Inc.	09 Jan 2024
Metastatic Pancreatic Ductal Adenocarcinoma	Phase 2	Netherlands	AstraZeneca PLC	09 Jan 2024
Post Acute COVID 19 Syndrome	Phase 2	United States	AIM ImmunoTech, Inc.	30 Jun 2023
Colorectal Cancer	Phase 2	-	AIM ImmunoTech, Inc.	11 Apr 2022
acute leukemia	Phase 2	United States	Roswell Park Comprehensive Cancer Center	17 Nov 2020
Chronic Lymphocytic Leukemia	Phase 2	United States	Roswell Park Comprehensive Cancer Center	17 Nov 2020
COVID-19	Phase 2	United States	Roswell Park Comprehensive Cancer Center	17 Nov 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05927142 (DURIPANC, GlobeNewswire) Manual	Phase 2	Metastatic Pancreatic Cancer	14	rintatolimod + durvalumab	wssxnbmmai(evipaudhrl) = emnzwckgws xyxyqeytqg (zbrqvyoxwt ) View more	Positive	28 Jul 2025
NCT03734692 (CTgov)	Phase 1/2	Recurrent ovarian cancer	24	cisplatin+Rintatolimod+Pembrolizumab	qnurctgaoi = ifswqfvqpe dmfewtccka (slyfpnavzv, ezpqmsgjzy - yovaqvxteu) View more	-	20 Jul 2025
NCT05592418 (AMP-518, CTgov)	Phase 2	Post Acute COVID 19 Syndrome	80	Rintatolimod (Ampligen / Rintatolimod)	eliwzfuoih(ckocfagqpb) = gorgbgzkft oduasetvjd (ikmladlehr, 9.31) View more	-	22 Jan 2025
NCT05592418 (AMP-518, CTgov)	Phase 2	Post Acute COVID 19 Syndrome	80	Placebo / Normal Saline (Placebo / Saline)	eliwzfuoih(ckocfagqpb) = fdezvbotcp oduasetvjd (ikmladlehr, 7.51) View more	-	22 Jan 2025
NCT05592418 (AMP-518, Corporate Publications) Manual	Phase 2	Post Acute COVID 19 Syndrome	66	Ampligen	zkncwiocqc(vlxyetqmjv) = between the Ampligen and placebo groups reached or approached statistical significance at several timepoints during the treatment phase. sstcsfrdgt (ppxeywfsqj ) View more	Positive	08 Feb 2024
NCT05592418 (AMP-518, Corporate Publications) Manual	Phase 2	Post Acute COVID 19 Syndrome	66	Placebo		Positive	08 Feb 2024
NCT03734692 (GlobeNewswire) Manual	Phase 2	Recurrent ovarian cancer	-	Ampligen+pembrolizumab	tgqwaypjvy(imysewuhnb) = Longitudinal comparison of biomarkers in tumor microenvironment showed a gradual, durable response over time in T lymphotactic CXCR3 ligands and cytolytic factors yxuuceamep (azpibcxtto )	Positive	08 Nov 2023
NCT04081389 (Phase I study, CTgov)	Phase 1	Triple Negative Breast Cancer \| Early Stage Breast Carcinoma	9	Interferon Alpha-2b (Arm 1: Interferon Alpha-2b at DL 1)	uqblmncpku = syhjkszdae bnwtgqjxqc (nlashjbwtw, rfjhjyqvpy - ybblyyoayo) View more	-	11 Sep 2023
NCT04081389 (Phase I study, CTgov)	Phase 1		9	Interferon Alpha-2b (Arm 2: Interferon Alpha-2b at DL 2)	uqblmncpku = vnfgfotqwz bnwtgqjxqc (nlashjbwtw, xunfpigyoo - aydmctxebt) View more	-	11 Sep 2023
Corporate Publications Manual	Phase 1	-	40	Rintatolimod	btjpqeytqu(zaubfblqnn) = kkuepwykiv vlkqwcpdvg (yxdufmunhc )	Positive	08 Dec 2022
Corporate Publications Manual	Phase 1	-	40	Placebo	btjpqeytqu(zaubfblqnn) = ckqwozsjgb vlkqwcpdvg (yxdufmunhc )	Positive	08 Dec 2022
NCT04081389 (SITC2022) Manual	Phase 1	Triple Negative Breast Cancer ER Negative \| HER2 Negative \| PR Negative	9	celecoxib+interferon (IFN)-α2b+rintatolimod	akupuasfri(pdpxcneinp) = nuseewkfgp gcoqazxqqb (tjziyirowa ) View more	Positive	01 Nov 2022
NCT00215813 (AMP-511, Biospace) Manual	Not Applicable	Post Acute COVID 19 Syndrome	4	Rintatolimod	ppzgauzser(nfhlruqmrp) = The preliminary data from this uncontrolled clinical trial found that patients reported statistically significant improvements in chronic fatigue after treatment with Ampligen pchphmofoq (aphimovtrd )	Positive	28 Jul 2022
NCT03403634 (AACR2022) Manual	Phase 2	Colorectal Liver Metastases Microsatellite Stable (MSS)	12	celecoxib+IFNα2b IV+rintatolimod	mjcpfycfrz(zsrgnaxrmp) = increased uqfcmjsrsq (ihrnzgusjt ) Met View more	Positive	15 Jun 2022

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