Phase II Vitargus® Clinical Study Protocol Receives Local Ethics Committee Approval
Fremont, CA - (NewMediaWire) - August 02, 2022 - ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced that the Ethics Committee (“EC”) of Srinagarind Hospital, Khon Kaen University of Thailand approved the Vitargus Phase II Clinical Study Protocol (ABV-1701-02). Srinagarind is one of two sites in Thailand that have agreed to participate in the study. The other site, Ramathibodi Hospital, Mahidol University, expects to receive EC approval in the near future. It is anticipated that a total of 20 or more patients undergoing vitreo-retinal surgery will be included in the studies at the selected sites. The final step prior to initiating the two studies is the issuance of an EC investigational product (IP) import license by the Food and Drug Administration of Thailand.
In addition, Vitargus Phase II Clinical Study protocol documents are now under review by the Australian Bellberry Human Research Ethics Committee (“HREC”). Upon approval, a Clinical Trial Notification (“CTN”) of the study will be issued leading to a final review by the Australian Therapeutic Goods Administration (“TGA”). Upon TGA approval, the clinical trial will begin in Australia at the previously selected sites.
“We are pleased to receive quick EC approval of the Vitargus Phase II study by Srinagarind Hospital, Khon Kaen University of Thailand,” said Dr. Howard Doong, Chief Executive Officer of the Company. “These two prestigious Thai clinical sites, plus the originally-planned Australia sites, are key to reaching our overall enrollment goals for the Phase II study of Vitargus.”
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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