Rintatolimod is under clinical development by AIM ImmunoTech and currently in Phase II for Prostate Cancer. According to GlobalData, Phase II drugs for Prostate Cancer have a 24% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Rintatolimod’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Rintatolimod overview

Ampligen is under development for the treatment of pancreatic cancer, HER positive breast cancer, metastatic triple negative breast cancer, colorectal cancer, HIV/AIDS infections, peritoneal cancer, pancreatic ductal adenocarcinoma, melanoma, urothelial cancer, prostate cancer, long COVID complications such as COVId-19 induced myalgic encephalomyelitis or chronic fatigue syndrome (ME/CFS), post COVID -19 cognitive dysfunction (PCCD) and Ebola viral infections. The drug candidate is administered by intravenous, intraperitoneal and nasal routes. It is a synthetic derivative of inosinic acid with antiretroviral and immunomodulatory activities. Ampligen (poly I: poly C12U) is a synthetic specifically configured double-stranded RNA containing regularly occurring regions of mismatching. It acts by targeting toll like receptor 3. The drug candidate is developed based on proprietary technology. It was also under development for the treatment of avian influenza (Japan, Canada), Ebola viral infections, West Nile virus infection, virus Zika infections, ovarian cancer, HIV infections H5N1, H7N9 influenza infections, renal cell carcinoma, metastatic melanoma, severe acute respiratory syndrome, non-small cell lung cancer and pandemic influenza.

AIM ImmunoTech overview

AIM ImmunoTech, formerly Hemispherx Biopharma, is an immuno- pharma company. The company focuses on the research and development of therapeutics for the treatment of multiple types of cancers, viruses and immune-deficiency disorders. Its flagship products include Ampligen (rintatolimod) sterile solution which is indicated for the treatment of patients with chronic fatigue syndrome; and Alferon N Injection used for the treatment of refractory or recurrent external condylomata acuminate. The company’s pipeline products are intended to treat various types of cancers, including ovarian, breast, colorectal, renal cell carcinoma, melanoma, pancreatic, bladder cancers, MERS and influenza virus. The company operates a production facility in New Brunswick, New Jersey. AIM ImmunoTech is headquartered in Ocala, Florida, the US.

For a complete picture of Rintatolimod’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.