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ABVC BioPharma Provides Vitargus Update

By: NewMediaWire

August 02, 2022 at 08:30 AM EDT

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.

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:

ICR, LLC

Lucy Peng

Phone: +1 646-677-1872

Email: Lucy.Peng@icrinc.com

View the original release on www.newmediawire.com

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ABVC BioPharma Provides Vitargus Update

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