ABVC BioPharma Provides Vitargus® Update - Phase II Vitargus® Study Protocol Received Thai FDA Approval
ABVC BioPharma (NASDAQ: ABVC) announced the approval of its Vitargus® Phase II Clinical Study Protocol by the Thailand FDA. Import licenses for the Vitargus device and SF6-Gas comparator have been issued for the two study sites in Thailand, enabling the initiation of the study by year-end 2022.
Twenty patients are expected to participate in the vitreo-retinal surgery study. Additionally, Australian sites are anticipated to receive approvals from the TGA in early 2023, with plans for further international study sites later in the year.
- Approval of Vitargus Phase II Clinical Study Protocol by Thailand FDA.
- Import licenses issued for Vitargus and SF6-Gas at two study sites.
- Expecting to initiate the study with 20 patients by the end of 2022.
- Potential for expansion with additional study sites in Australia and other countries.
- Dependence on successful regulatory approvals for further trials.
- Risk of delays in obtaining approvals from additional regulatory bodies.
FREMONT, CA, Nov. 17, 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 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.
Forward-Looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential,” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified, and, consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to proceed to the next level of the clinical trials or to market our product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
Contact:
Leeds Chow
CFO
Email: leedschow@ambrivis.com
FAQ
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