ABVC BioPharma Provides Vitargus® Update

2022年08月18日20:30

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.

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

Stephanie Oshchepkov

Phone: +1 (203) 682-7175

Email: Stephanie.Oshchepkov@icrinc.com

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