AIM ImmunoTech has signed a clinical trial agreement (CTA) with Roswell Park Comprehensive Cancer Center for a Phase I/IIa clinical trial of Ampligen (rintatolimod) in combination with interferon alfa-2b for the treatment of Covid-19 patients with cancer.
Funding for the study is partially supported by grants from the National Cancer Institute and AIM, with institutional support from Roswell Park.
The trial will be performed at Roswell Park and is set to begin enrolment in one month.
During the study, the safety and effectiveness of the Ampligen combination for clearing the SARS-CoV-2 virus from the upper airway will be assessed in cancer patients with mild to moderate Covid-19.
Roswell Park Molecular Therapeutics and Translational Research professor Pawel Kalinski said: “The trial is a signature element of Roswell Park’s work to optimise immune-based approaches for treating cancer and infectious diseases, and AIM’s support for our vision helped ensure that we could bring this novel approach to patients.”
The trial’s Phase I part is expected to involve 12 to 24 patients who will be given Ampligen and interferon alfa-2b at escalating doses.
After the Phase I part is complete, the study’s Phase IIa portion will be commenced. In the this portion, patients will receive the combination regimen or best available care.
AIM expects Ampligen plus interferon alfa-2b to benefit cancer patients with Covid-19.
Based on the the immuno-oncology data of this combination in previous cancer trials, the company hopes for an early innate immune response in cancer patients, while limiting viral replication and preventing transmission to other cells.
AIM ImmunoTech CEO Thomas Equels said: “Based on the preclinical studies, we are encouraged by the potential for an effective early-onset treatment against this new and deadly virus especially for cancer patients, who face significantly increased risk of severe symptoms or death.”
The company plans to leverage data from this trial for testing Ampligen in other high risk and immunocompromised Covid-19 patient populations.