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Rintatolimod - AIM ImmunoTech

Drug Profile

Rintatolimod - AIM ImmunoTech

Alternative Names: AMP-516; AMP-518; Ampligen; Atvogen; Mismatched double-stranded RNA - AIM ImmunoTech; Poly I:Poly C12U; Poly I:polyC12U; poly(I) poly(C12,U); Rintamod; Vaccine-adjuvant-poly-I-polyC12U; Vaccine-adjuvant-rintatolimod

Latest Information Update: 28 Mar 2024

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At a glance

  • Originator Hemispherx Biopharma
  • Developer AIM ImmunoTech; Centre for Human Drug Research; Erasmus MC; National Cancer Institute (USA); Roswell Park Cancer Institute; United States Army Medical Research Institute of Infectious Diseases; University of Pittsburgh
  • Class Adjuvants; Antineoplastics; Antiretrovirals; Antivirals; Oligonucleotides
  • Mechanism of Action HIV replication inhibitors; Immunostimulants; Interferon stimulants; Ribonuclease stimulants; RNA synthesis inhibitors; Toll-like receptor 3 agonists; VP35 protein inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Renal cell carcinoma; Pancreatic cancer; Ebola virus infections; Chronic fatigue syndrome; HIV infections; Malignant melanoma
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Marketed Chronic fatigue syndrome; HIV infections; Malignant melanoma; Renal cell carcinoma
  • Phase II Colorectal cancer; Pancreatic cancer; Post acute COVID 19 syndrome; Prostate cancer; Triple negative breast cancer
  • Phase I/II COVID 2019 infections; Influenza virus infections; Ovarian cancer; Peritoneal cancer
  • Preclinical Ebola virus infections
  • No development reported Hepatitis B; Influenza A virus infections
  • Discontinued Smallpox; West Nile virus infections; Western equine encephalitis virus infections; Zika virus infection

Most Recent Events

  • 25 Mar 2024 Interim pharmacodynamics data from an expanded access program in Pancreatic cancer released by AIM ImmunoTech
  • 08 Feb 2024 Efficacy and adverse events data from a phase II trial in Post-acute-COVID-19-syndrome released by AIM ImmunoTech
  • 25 Jan 2024 Hemispherx Biopharma in collaboration with National Cancer Institute and Roswell Park Comprehensive Cancer Center reinitiates a phase II trial in Prostate cancer (Combination therapy, Late-stage disease, Neoadjuvant therapy) in USA (IV) in January 2024 (NCT03899987)
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