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Ainos, Inc. Receives IRB Approval From National Taiwan University Hospital for HIV-Oral Warts Clinical Trial, Highlighting Value of FDA-Designated Orphan Drug VELDONA
Ainos, Inc. (NASDAQ:AIMD) has received Institutional Review Board (IRB) approval from the National Taiwan University Hospital for its clinical trial on VELDONA®, a low-dose oral interferon formulation for treating oral warts in HIV-positive patients. The trial, involving 40 participants, will evaluate VELDONA®'s efficacy in combination with antiretroviral therapy. VELDONA® has received orphan drug designation from the FDA, highlighting its potential in addressing an unmet medical need.

The next step is obtaining approval from the Taiwan Food and Drug Administration (TFDA). The application was submitted on August 28, 2024. The Site Initiation Visit is expected in November 2024, with patient enrollment lasting one year. The study is anticipated to conclude by July 2026.
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