AIM ImmunoTech Inc (NYSEAMERICAN:AIM) (FRA:HXB2) has entered into a two-year agreement extension with Shenzhen Smoore Technology Limited (Smoore) with the goal of developing Ampligen as a potential inhalation therapy for coronavirus (COVID-19) and other respiratory viral diseases.
In April 2020, AIM entered into the material transfer and research agreement to study the utilization of an innovative Smoore inhalation delivery device and Ampligen as a potential treatment approach for the SARS-CoV-2 pandemic.
On parallel paths, over the past year, AIM said Smoore has focused on the development of a personal inhalation device designed to administer Ampligen, given temperature parameters of dsRNA. Smoore is a subsidiary of Smoore International Holdings Limited.
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Contemporaneously, AIM has studied the safety and efficacy of Ampligen, using an ex vivo 3D model in primary human respiratory epithelial cells at the Utah State University, which showed that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels.
Ocala, Florida-based AIM noted that it hopes to commence inhalation safety testing before year-end.
"With Smoore’s concept for an Ampligen inhalation delivery device ready to be developed, and Ampligen’s track record of both safety and efficacy, we believe AIM is well positioned to move forward with our goal of developing Ampligen as a potential inhalation therapy for COVID-19 and potentially other respiratory viral diseases,” said AIM CEO Thomas Equels in a statement.
"We are in the process of planning a Phase 1/2 inhalation clinical study on a parallel track with Smoore’s device development testing.”
Dr Zhiqiang Shi, chief scientist and director of global R&D at Smoore, added: “Application of vaping technology in healthcare and pharmaceutical fields is one of our R&D focus. We are really happy to partner with AIM to explore applications of advanced atomization technology in medical inhalation therapy. We will coordinate our device development work along with our partner’s plan and the regulation needs to move into next phase testing on schedule.”
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