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Ainos’ VELDONA Granted Orphan Drug Designation by U.S. FDA for Potential Treatment of Oral Warts in HIV-Seropositive Patients
VELDONA® positioned as a potential treatment option for over 24,000 HIV-seropositive AmericansSAN DIEGO, CA / ACCESSWIRE / September 18, 2023 / Ainos, Inc.
About this update from Ainos, Inc.
[{"type":"text","content":"VELDONA® positioned as a potential treatment option for over 24,000 HIV-seropositive AmericansSAN DIEGO, CA / ACCESSWIRE / September 18, 2023 / Ainos, Inc. (NASDAQ: AIMD, AIMDW) (\"Ainos\", or the \"Company\"), a diversified healthcare company focused on the development of AI-powered point-of-care testing, low-dose interferon therapeutics, and synthetic RNA-driven preventative medicine, announced today that the United States Food and Drug Administration (the \"U.S. FDA\") granted Orphan Drug Designation (\"ODD\") for the Company's VELDONA® low-dose oral interferon formulation as a potential treatment for oral warts in HIV-seropositive patients. Ainos plans to pursue a pre-IND meeting with the U.S. FDA in advance of planned Phase III clinical studies for the drug candidate.Mr. Chun-Hsien (Eddy) Tsai, Chairman of the Board, President, and Chief Executive Officer of Ainos, commented, \"We are deeply excited that VELDONA® may be able to improve the quality of life of many people living with HIV. Of the estimated 1.2 million HIV-seropositive people in the United States, about 24,000 of them suffer from HIV-related oral warts, representing approximately 2% of the HIV-seropositive population. It is estimated that oral warts affected around 1.2 million HIV patients worldwide in 2022. Oral warts can significantly reduce a person's quality of life, causing discomfort during routine activities such as eating and talking, and affecting a person's appearance. We are optimistic that VELDONA® will serve as a new option for HIV-seropositive individuals seeking relief from oral warts.\"Human immunodeficiency virus, more commonly known as HIV, is a disease which destroys the body's CD4 cells, which are crucial to immune function. It can increase a patient's susceptibility to opportunistic infections such as human papillomavirus (\"HPV\"), tuberculosis, and fungal and bacterial infections. HPV infection has been identified as the most significant risk factor in the development of oral lesions among the HIV-seropositive population. Viral lesions on the mouths of HIV patients are common and may be indicative of disease progression.Current treatment options for HIV-related oral warts are limited. Pharmacological treatment of intraoral and labial warts is not well established, with no clinical trials specifically targeting this indication. Only a hand...