ABVC BioPharma Announces Vitargus® Phase II Study Plan Approved by HREC in Australia
10/05/2022 - 08:30 AM
FREMONT, CA, Oct. 05, 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 its Vitrargus Phase II study plan was approved by the Australian Bellberry Human Research Ethics Committee (HREC) on September 29, 2022. Subsequently, a Clinical Trial Notification (CTN) was submitted to the Australian Therapeutic Goods Administration (TGA) for the initiation of the study in Australia.
Early clinical studies indicate that Vitargus has unique properties that eliminate the need for positioning patients face-down post-surgery and result in significantly greater patient comfort and visual acuity during surgical recovery than currently available products. The objective of the Phase II study entitled “A Perspective Multi-Site Open Label Randomized Controlled Clinical Investigation of the Safety and Effectiveness of ABV-1701 Ocular Endotamponade (OE)” is to demonstrate the safety and effectiveness of Vitargus for the treatment of uncomplicated retinal detachment when compared to the commonly used SF6 Gas OE. The Phase II study will be conducted in Thailand as well as Australia and will include a total of at least 40 subjects.
“We are pleased to have received approval from the Australian Bellberry Human Research Ethics Committee (HREC) for the Vitargus Phase II study, which follows approval from the Central Research Ethics Committee (CREC) of The National Research Council of Thailand,” said Dr. Howard Doong, Chief Executive Officer of the Company. “We are aiming to conduct site initiation visits (SIVs) next month in both Thailand and Australia so that we can begin the study in early 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 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
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