Ainos Inc (AIMD)

[Maker13]

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



Company Update

Ainos Plans To Conduct the Study at National Taiwan University Hospital, a Premier Taiwanese Medical Center for HIV Management



The 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.



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Overview of the Clinical Study

This 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 Practice (GCP) guidelines by Bestat Pharmaservices Corporation, a TFDA-certified Contract Research Organization (CRO). The study is expected to begin in November 2024, with the first patient visit (FPFV) anticipated in November. Patient enrollment is projected to take one year, with the last patient visit (LPLV) expected in May 2026, and study completion anticipated in July 2026. Protocol of the study is currently being reviewed for Investigational Review Board ("IRB") approval by National Taiwan University Hospital and Taiwan Food and Drug Administration (TFDA).



Data from Prior Studies

Ainos has conducted one pilot study and two phase 2 trials in the U.S. involving 77 HIV-positive patients with multiple oral warts. In these trials, patients were randomized to receive either VELDONA® or a placebo, taking the medication three times daily for 24 weeks. After treatment, patients receiving VELDONA® showed significant reductions in oral wart surface area, with decreases of over 75%, and in some cases up to 99%.



Overview of HIV

Human Immunodeficiency Virus (HIV) is the virus responsible for causing AIDS, with two main types: HIV-1 and HIV-2. HIV-1 is the dominant strain worldwide and is the primary cause of AIDS in most countries. HIV-2, found predominantly in West Africa, is less virulent and less likely to progress to AIDS.

According to the Joint United Nations Programme on HIV/AIDS (UNAIDS), in 2023, there were approximately 39.9 million people living with HIV worldwide, with 1.3 million new infections and about 630,000 AIDS-related deaths.

In Taiwan, there were around 35,500 individuals living with HIV and 940 reported new cases in 2023. There were 666 new reported cases in August 2024.



Challenges in Treating HIV-Related Oral Warts

Currently, treatment options for HIV-related oral warts are limited, and no established pharmacological therapies exist for this condition. Only a few case reports mention the use of drugs such as cidofovir, bleomycin, cimetidine, podophyllum, or intralesional interferon-alpha injections. Surgical removal is possible but comes with the risk of recurrence.

Ainos believes that VELDONA® has the potential to be a safe and effective treatment for oral warts in HIV-positive individuals, offering a meaningful improvement in their quality of life.

"We are excited by the data we've gathered so far and are optimistic about the potential of VELDONA® to benefit many HIV-positive patients. Oral warts can significantly affect daily activities such as eating and speaking, as well as a person's appearance. We are hopeful that VELDONA® will become an important option for those seeking relief from these symptoms," said Chun-Hsien (Eddy) Tsai, Chairman of the Board, President, and Chief Executive Officer of Ainos
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About Ainos, Inc.

Headquartered in San Diego, California, Ainos is a diversified healthcare company focused on novel AI-powered point-of-care testing (POCT) and low-dose interferon therapeutics (VELDONA). The Company's clinical-stage product pipeline includes VELDONA human and animal oral therapeutics, human orphan drugs, and telehealth-friendly POCT solutions powered by its AI Nose technology platform.

The name "Ainos" is a combination of "AI" and "Nose" to reflect the Company's commitment to empowering individuals to manage their health more effectively with next-generation AI-driven POCT solutions. To learn more, visit https://www.ainos.com.

Follow Ainos on X, formerly known as Twitter, (@AinosInc) and LinkedIn to stay up-to-date.




Contact Information

Feifei Shen
[e-mail]

SOURCE: Ainos, Inc.



https://www.accesswire.com/918831/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