AIM ImmunoTech Inc. is initiating a plan to further develop Ampligen as a vaccine adjuvant for avian influenza. The company has engaged Amarex Clinical Research to manage an Investigational New Drug (IND) application for a combination therapy study involving Ampligen and AstraZeneca’s FluMist. AIM is actively pursuing grants to support the study’s costs.
This development is crucial because avian influenza poses a significant and growing threat to public health. A successful combination therapy could offer broader protection and easier administration (intranasal) compared to current influenza vaccines. This approach has the potential to address a critical unmet need for a more effective and accessible preventative measure against avian flu, which could significantly impact public health outcomes globally.
This planned IND builds upon previous clinical research at the University of Alabama-Birmingham, where intranasal Ampligen administration following FluMist amplified the immune response to seasonal influenza strains and induced cross-reactive antibodies against highly pathogenic avian influenza strains (H5N1, H7N9, and H7N3). Prior pre-clinical studies demonstrated Ampligen’s ability to induce cross-reactive antibodies against H5N1 in mice when administered with a trivalent flu vaccine and also showed protective effects against H5N1 in non-human primates. A human safety study confirmed that repeated intranasal Ampligen administration was well-tolerated.
This initiative marks a critical step in advancing a potential solution for the increasing threat of avian influenza. The combination of Ampligen and FluMist offers a promising approach to enhance vaccine efficacy and broaden protection. The planned clinical trial, along with continued research and development, could lead to a significant advancement in preventing avian influenza and safeguarding public health.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
