OPORF - AIM ImmunoTech inks clinical trial agreement for Phase 2a Human Challenge Trial of Ampligen
AIM ImmunoTech (NYSE:AIM) and hVIVO, a subsidiary of Open Orphan (OTCPK:OPORF) have a signed Clinical Trial Agreement for a Phase 2a Human Challenge Trial (HCT) to test AIM's drug Ampligen as a potential intranasal prophylactic using a human rhinovirus (HRV-16, a common cold virus) and influenza A virus (H3N2). This antiviral study is expected to start in Q4 2021. In Phase 2a HCT study of Ampligen administered intranasally, healthy participants will be intentionally exposed to particular diseases to test how the diseases will respond to potential therapeutics. A total of 64 participants are planned to participate; 32 will be randomized and inoculated with influenza A/Perth/16/2009 (H3N2) and 32 with HRV-16. In each group, 16 participants will be receiving Ampligen and 16 will receive placebo. An HCT will allow AIM to expedite the development process for Ampligen by ensuring full exposure of both the control group and the Ampligen group, so as to assess
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AIM ImmunoTech inks clinical trial agreement for Phase 2a Human Challenge Trial of Ampligen