AIM ImmunoTech Announces Addition of Single-Agent Ampligen Arm to Cancer Center’s Ongoing Study in Cancer Patients with COVID-19

On March 22, 2021 AIM ImmunoTech Inc. (NYSE American: AIM) reported that the Institutional Review Board (IRB) of Roswell Park Comprehensive Cancer Center (Roswell Park) has approved a protocol amendment to Roswell Park’s ongoing Phase 1/2a study evaluating the two-drug combination of AIM’s Ampligen and interferon alpha-2b as a potential early-onset treatment for patients with cancer and mild-to-moderate COVID-19 (Press release, AIM ImmunoTech, MAR 22, 2021, View Source [SID1234576991]).

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The IRB-approved amendment calls for randomization of an additional twenty patients. Ten of these patients will receive a single dose of Ampligen, but no interferon treatment, and the other ten will receive best available care only. Ampligen alone has a generally well-tolerated safety profile with lower risk of adverse events than is generally expected with interferon therapy.

"We are excited to see Ampligen tested not only as part of an antiviral treatment combination for COVID-19 among cancer patients, but also as a possible standalone therapy for this terrible virus," said AIM CEO Thomas K. Equels. "An early-onset treatment is especially critical for cancer patients, who face significantly increased risk of severe symptoms or death."

AIM previously announced in November 2020 that the first patient had been enrolled and received treatment in Roswell Park’s study. Funding for the clinical trial is provided, in part, through grants from the National Cancer Institute and AIM, as well as institutional support from Roswell Park.

Full details about this trial under way at Roswell Park, led by co-Principal Investigators Drs. Brahm Segal and Pawel Kalinski, are available at ClinicalTrials.gov.