ABVC BioPharma (ABVC) Provides Vitargus Update

ABVC BioPharma, Inc. (NASDAQ: ABVC) 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.”

You May Also Be Interested In