Fremont, CA - (NewMediaWire) - November 17, 2022 - ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced that the Vitargus® Phase II Clinical Study Protocol has been approved by the Thailand Food and Drug Administration (FDA). Import licenses for the Vitargus medical device and SF6-Gas used as a comparator in the clinical study were issued to both TH001 and TH002 study sites in Thailand on November 2, 2022.
Vitargus medical devices and SF6-Gas comparators will be shipped to Ramathibodi Hospital, Mahidol University located in Bangkok (TH001) and Srinagarind Hospital, Khon Kaen University located in Khon Kaen Province (TH002) in preparation for the Site Initiation Visit (SIV) of the study planned to begin before the end of 2022. It is expected that a total of 20 or more patients undergoing vitreo-retinal surgery will be included in the study at the two selected sites.
“We are pleased that our two Vitargus Phase II study sites in Thailand have received Import licenses from the Thai FDA and can begin the study before the end of this year,” said Dr. Howard Doong, Chief Executive Officer of the Company. “We also note that our two Australian sites are soon expected to receive the green light from the Australian Therapeutic Goods Administration (TGA) allowing us to proceed with the Australian study in early 2023.” Dr. Doong further noted that “more study sites will be added in other countries later in 2023.”
About ABVC BioPharma
ABVC BioPharma is a clinical-stage biopharmaceutical company with an active pipeline of six drugs and one medical device (ABV-1701/Vitargus®) under development. For its drug products, it is focused on utilizing its licensed technology to conduct proof-of-concept trials through Phase II of the clinical development process at world-famous research institutions (such as Stanford University, University of California at San Francisco, and Cedars-Sinai Medical Center). For Vitargus®, the company intends to conduct the clinical trials through Phase III at various locations throughout the globe.
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