Phase II Vitargus® Clinical Trial Receives Local Ethics Committee Approval in Thailand
FREMONT, CA, Aug. 18, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire – ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical-stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced that, on August 2, 2022, approval was received from the Ethics Committee (EC) of the Ramathibodi Hospital, Mahidol University to conduct the Vitargus Phase II Study Protocol (ABV-1701-02). This follows a similar approval received on July 18, 2022, by Srinagarind Hospital, Khon Kaen University of Thailand.
Both hospitals now expect to receive a Thai FDA investigational product (IP) import license within the next 30 days, which will allow them to initiate the clinical study in Thailand entitled “A Prospective Multi-Site Randomized Controlled Clinical Investigation of the Safety and Effectiveness of the ABV1701 Ocular Endotamponade (OE).”
In parallel, Vitargus Phase II Study protocol documents have been submitted to the Australian Bellberry Human Research Ethics Committee (HREC). Upon approval by the HREC, ABVC will submit an application to the Australian Therapeutic Goods Administration (TGA) for a Clinical Trial Notification (CTN) of the study, which is the final step before the three selected study sites in Australia can begin the trial.
“We continue to move closer to initiation of Vitargus Phase II clinical trials in Thailand and Australia,” said Dr. Howard Doong, Chief Executive Officer of the Company. “And, we expect to begin clinical trials in other Asia-Pacific countries before the end of 2022.” Dr. Doong further noted, “Animal studies requested by the United States FDA in connection with Vitargus are going well, making it likely that Phase II studies can be conducted in the US starting in 2024.”
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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