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Ainos Announced Plan to Initiate Taiwan Clinical Study for VELDONA as Potential Treatment of Oral Warts in HIV-Seropositive Patients, an Orphan Drug Designated by the FDA
Ainos Plans To Conduct the Study at National Taiwan University Hospital, a Premier Taiwanese Medical Center for HIV ManagementThe U.S. FDA Have Granted Orphan
About this update from Ainos, Inc.
[{"type":"text","content":"Ainos Plans To Conduct the Study at National Taiwan University Hospital, a Premier Taiwanese Medical Center for HIV ManagementThe U.S. FDA Have Granted Orphan Drug Designation (ODD) for the Company's VELDONA® Low-Dose Oral Interferon Formulation as a Potential Treatment for Oral Warts in HIV-Positive Patients SAN DIEGO, CA / ACCESSWIRE / September 17, 2024 / Ainos, Inc. (NASDAQ:AIMD)(NASDAQ:AIMDW) (\"Ainos\" or the \"Company\"), an innovative healthcare company focused on advanced AI-driven point-of-care testing (POCT) and low-dose interferon therapeutics, is pleased to announce that its plans to initiate a clinical study for very low-dose interferon alpha (VELDONA) on treating Human immunodeficiency virus (HIV)-related oral warts at the National Taiwan University Hospital. The study aims to evaluate the efficacy of VELDONA®, a low-dose oral interferon-alpha formulation, in treating oral warts in HIV-positive patients undergoing combination antiretroviral therapy. VELDONA® has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for this indication, offering new hope to HIV-positive individuals suffering from oral warts.Overview of the Clinical StudyThis clinical study will be conducted by the Infectious Disease Department at National Taiwan University Hospital, one of Taiwan's 25 designated medical centers for HIV management. The hospital oversees nearly 4,000 HIV-positive patients, approximately 11.2% of Taiwan's total HIV cases. The study will enroll 40 participants who will be randomized in a 1:3 ratio to receive either a placebo or VELDONA® in a double-blind trial. Participants will take VELDONA® or a placebo sublingually every day for 24 weeks.The primary objective of the study is to evaluate the reduction in oral warts' surface area. A successful response is defined as a reduction of 75% or more in the surface area of oral warts compared to baseline, while a non-responsive result indicates less than 75% reduction.The secondary objectives include evaluating oral wart surface area reduction by 50% or more, as well as participant self-assessments through questionnaires comparing oral health to baseline conditions. The study's Principal Investigator (PI) will also objectively assess the participants' oral conditions.This clinical study will be conducted in accordance with Good Clinical Pra...