ABVC BioPharma Provides Vitargus Update on Phase II Site Initiation Visit Conducted at Ramathibodi Hospital in Thailand
ABVC BioPharma, a clinical-stage biopharmaceutical company, announced a successful Phase II Site Initiation Visit (SIV) for its product Vitargus® at Ramathibodi Hospital in Thailand on March 22, 2023. This study aims to evaluate the safety and effectiveness of Vitargus® in patients with retinal detachment compared to Sulphur Hexafluoride gas. The company is initiating patient enrollment across multiple sites, targeting at least 40 participants. Early studies show Vitargus® may enhance patient comfort and visual acuity, potentially eliminating the need for additional surgery post-treatment.
ABVC BioPharma is focused on developing innovative solutions in oncology, CNS, and ophthalmology, with an active pipeline of six drugs and the Vitargus® medical device under development.
- Successful Phase II Site Initiation Visit conducted for Vitargus® at Ramathibodi Hospital.
- Initiation of patient enrollment targeting at least 40 patients across four sites.
- Early studies indicate Vitargus® enhances patient comfort and visual acuity during recovery.
- None.
Fremont, CA, April 06, 2023 (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 Vitargus® Phase II Site Initiation Visit (SIV) at Ramathibodi Hospital, Faculty of Medicine, Mahidol University (TH001) in Thailand was successfully conducted on March 22, 2023. The SIV was an organized meeting to discuss the Phase II study protocol with the principal investigator, Duangnate Rojanaporn, M.D. and begin training clinical personnel.
Vitargus® Phase II study with the protocol “A Prospective Multi-Site Open-Label Randomized Controlled Clinical Investigation of the Safety and Effectiveness of ABV-1701 Ocular Endotamponade (OE)” is to demonstrate safety and effectiveness of Vitargus® in patients with Retinal Detachment compared to the commonly used Sulphur Hexafluoride (SF6) Gas OE. The Phase II study screening and enrollment has been initiated and will aim to enroll at least 40 patients across all four sites in Australia and Thailand. More information on the clinical trial (NCT05414747) can be found here.
Early clinical studies done by the Company indicate Vitargus® has unique properties that could eliminate the need for patients to remain in a face-down position post-surgery, while significantly improving patient comfort and visual acuity during surgical recovery compared to current products available on the market. Vitargus® is believed to be the first biodegradable vitreous substitute to eliminate the need for an additional surgery to remove surgical fluids.
“We are pleased to see the SIV completed successfully with Dr. Duangnate Rojanaporn, M.D. and her clinical team at Ramathibodi Hospital, Faculty of Medicine, Mahidol University (TH001), and are ready for patient screening and enrollment,” said Dr. Howard Doong, Chief Executive Officer of the Company. “We are currently enrolling patients at Srinagarind Hospital, Khon Kaen University (TH002), which completed its SIV on March 10, 2023. The SIVs at Sydney Eye Hospital (AU001) and East Melbourne Eye Group (AU002) in Australia are expected to be conducted shortly.”
According to iHealthcareAnalyst, Inc., the global market for retinal surgery devices is expected to reach
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, the company utilizes in-licensed technology from its network of world-renowned research institutions to conduct proof-of-concept trials through Phase II of clinical development. The company’s network of research institutions includes Stanford University, University of California at San Francisco, and Cedars-Sinai Medical Center. For Vitargus®, the company intends to conduct global clinical trials through Phase III.
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. None of the outcomes expressed herein are guaranteed. 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:
Tom Masterson
Email: tmasterson@allelecomms.com
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