AIM ImmunoTech Inc (NYSEAMERICAN:AIM) has announced that the Institutional Review Board (IRB) of Roswell Park Comprehensive Cancer Center 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 coronavirus (COVID-19).
AIM ImmunoTech said the IRB-approved amendment calls for randomization of an additional 20 patients. Ten of these patients will receive a single dose of Ampligen, but no interferon treatment. The other 10 only will receive the best available care.
The company noted that Ampligen alone has a generally well-tolerated safety profile with a lower risk of adverse events than is generally expected with interferon therapy.
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"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 ImmunoTech CEO Thomas Equels in a statement.
“An early-onset treatment is especially critical for cancer patients, who face significantly increased risk of severe symptoms or death."
AIM ImmunoTech 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 the company, as well as institutional support from Roswell Park.
Full details about the trial at Roswell Park, led by co-principal investigators - Dr Brahm Segal and Dr Pawel Kalinski - are available at ClinicalTrials.gov.
Contact the author: patrick@proactiveinvestors.com
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