ABVC BioPharma Provides Vitargus® Update
ABVC BioPharma has received approval from the Thailand Central Research Ethics Committee for its Vitargus® Phase II Clinical Study. This approval includes the study protocol and other essential documents. The trials will take place at Ramathibodi Hospital and Srinagarind Hospital, with over 20 patients expected to participate. The clinical studies in Thailand will run parallel to Australian sites, aiming for expedited patient results. The global market for retinal surgery devices is projected to reach $3.7 billion by 2027, driven by an aging population.
- Approval from Thailand's Central Research Ethics Committee for Vitargus® Phase II study.
- Studies will proceed at prestigious hospitals in Thailand, enhancing credibility.
- The global retinal surgery device market projected to reach $3.7 billion by 2027, indicating strong market potential.
- None.
Vitargus® Receives Phase II Thailand Central Research Ethics Committee Approval
FREMONT, CA, June 30, 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 Central Research Ethics Committee (CREC) of The National Research Council of Thailand. The approval encompasses the study protocol as well as the Master Informed Consent Form (Master ICF), Case Report Form (CRF) and the Investigator’s Brochure (IB), along with other relevant documents.
ABVC has selected the Thailand, Ramathibodi Hospital, Mahidol University located in Bangkok and Srinagarind Hospital, Khon Kaen University located in Khon Kaen Province to initiate the study subject to local Ethics Committee (EC) approval and receipt of a Thai FDA study product import license. It is expected that a total of 20 or more patients undergoing vitreo-retinal surgery will be included in the study at the selected sites.
“We are pleased to receive this key approval to proceed with the Vitargus® Phase II study in Thailand,” said Dr. Howard Doong, Chief Executive Officer of the Company. “The two prestigious Thailand clinical sites will run in parallel with the Australian study sites to provide more patient results sooner than we had anticipated.” Dr. Doong further noted that, “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, 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
FAQ
What recent approval did ABVC BioPharma receive for Vitargus®?
Where will the Vitargus® Phase II study take place?
How many patients are expected to participate in the Vitargus® study?
What is the projected market size for retinal surgery devices by 2027?
