AIM ImmunoTech Inc (NYSEAMERICAN:AIM) revealed on Thursday that it has struck a clinical trial agreement (CTA) with Roswell Park Comprehensive Cancer Center to support its Phase 1/2a trial of Ampligen (rintatolimod) in combination with interferon alfa-2b, in cancer patients with COVID-19, the disease caused by the SARS-CoV-2 coronavirus.
Funding for the clinical trial is being provided, in part, through grants from the National Cancer Institute and AIM, as well as institutional support from Roswell Park.
In a statement, AIM ImmunoTech CEO Thomas K Equels said: "We are excited to team up with Roswell Park, a leading cancer research center, to test Ampligen as part of an antiviral treatment combination for COVID-19 among cancer patients.”
He added: “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.”
Equels said the immuno-pharma company looked forward to leveraging the “important clinical trial” for cancer patients with COVID-19, if successful, into tests of Ampligen in other “high-risk and immunocompromised COVID-19 groups."
"We are very grateful for AIM's participation and collaboration in this study, which represents an important potential treatment option for cancer patients with COVID-19," said Pawel Kalinski, who is the vice-chair for translational research at Roswell Park, and scientific lead on the new clinical trial as well as five other related studies.
"The trial is a signature element of Roswell Park's work to optimize 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."
Patient enrollment, which will be conducted at Roswell Park under the clinical leadership of Brahm Segal, chair of internal medicine at the Buffalo, New York-based cancer center, is expected to begin within 30 days.
Roswell Park is the sponsor of the new clinical trial, which will test the safety and effectiveness of this combination regimen to clear the SARS-CoV-2 virus from the upper airway in patients with cancer and mild to moderate COVID-19. The initial Phase 1 portion of the study will evaluate 12-24 patients receiving both Ampligen and interferon alfa-2b at escalating doses.
Once the Phase I portion is complete, the Phase 2a portion of the study will be initiated with patients randomized into two arms: one receiving the two-drug combination and a control group who will not receive Ampligen or interferon alfa-2b, but will receive best available care.
Ocala, Florida-based AIM ImmunoTech is helping to fund the study and will provide its drug Ampligen (rintatolimod) at no charge for the study.
As announced in May, the US Food and Drug Administration (FDA) has permitted the trial to proceed.
Contact the author Uttara Choudhury at [email protected]
Follow her on Twitter: @UttaraProactive