Vitargus® Receives Phase II Thailand Central Research Ethics Committee Approval
Fremont, CA - (NewMediaWire) - June 30, 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 Central Research Ethics Committee (CREC) of The National Research Council of Thailand. The approval encompasses the study protocol as well as the Master Informed Consent Form (Master ICF), Case Report Form (CRF) and the Investigator’s Brochure (IB), along with other relevant documents.
ABVC has selected the Thailand, Ramathibodi Hospital, Mahidol University located in Bangkok and Srinagarind Hospital, Khon Kaen University located in Khon Kaen Province to initiate the study subject to local Ethics Committee (EC) approval and receipt of a Thai FDA study product import license. It is expected that a total of 20 or more patients undergoing vitreo-retinal surgery will be included in the study at the selected sites.
“We are pleased to receive this key approval to proceed with the Vitargus® Phase II study in Thailand,” said Dr. Howard Doong, Chief Executive Officer of the Company. “The two prestigious Thailand clinical sites will run in parallel with the Australian study sites to provide more patient results sooner than we had anticipated.” Dr. Doong further noted that, “According to iHealthcareAnalyst, Inc., the global market for retinal surgery devices is expected to reach $3.7 billion by 2027 driven by a rising geriatric population worldwide.”
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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