Srinagarind Hospital

ABVC BioPharma Provides Vitargus Update on Phase II Site Initiation Visit Conducted at Ramathibodi Hospital in Thailand

Retrieved on: 
Thursday, April 6, 2023

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.

Key Points: 
  • 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.
  • 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.
  • “We are currently enrolling patients at Srinagarind Hospital, Khon Kaen University (TH002), which completed its SIV on March 10, 2023.

ABVC BioPharma Receives Australian TGA Approval to Initiate Phase II Study of Vitargus®

Retrieved on: 
Tuesday, February 21, 2023

FREMONT, CA, Feb. 21, 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 approval to initiate the Phase II study of its Vitargus® medical device, in Australia, was received from the Australian Therapeutic Goods Administration (TGA) on February 9, 2023.

Key Points: 
  • FREMONT, CA, Feb. 21, 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 approval to initiate the Phase II study of its Vitargus® medical device, in Australia, was received from the Australian Therapeutic Goods Administration (TGA) on February 9, 2023.
  • “We are pleased to receive Vitargus Phase II study approval from Australian TGA to enable initiating the study at two prestigious Australian sites,” said Dr. Howard Doong, Chief Executive Officer of the Company.
  • Matthew Simunovic in New South Wales and East Melbourne Eye Group & East Melbourne Retina directed by Dr. Elvis Ojaimi in East Melbourne, will participate in the study.
  • Along with Thai FDA approved Ramathibodi Hospital and Srinagarind Hospital in Thailand, the study will enroll a total of at least 40 subjects.

ABVC BioPharma Provides Vitargus® Update - Phase II Vitargus® Study Protocol Received Thai FDA Approval

Retrieved on: 
Thursday, November 17, 2022

FREMONT, CA, Nov. 17, 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 Thailand Food and Drug Administration (FDA).

Key Points: 
  • FREMONT, CA, Nov. 17, 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 Thailand Food and Drug Administration (FDA).
  • We are pleased that our two Vitargus Phase II study sites in Thailand have received Import licenses from the Thai FDA and can begin the study before the end of this year, said Dr. Howard Doong, Chief Executive Officer of the Company.
  • 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 Vitargus, the company intends to conduct the clinical trials through Phase III at various locations throughout the globe.

ABVC BioPharma Selects Additional Vitargus® Phase II Study Site

Retrieved on: 
Friday, September 9, 2022

FREMONT, CA, Sept. 09, 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 a new clinical site in Australia has been selected to participate in the Phase II clinical study of Vitargus®, the first bio-degradable vitreous substitute to facilitate retina re-attachment surgery. The new site, located at the Sydney Eye Hospital in Sydney, New South Wales, will join East Melbourne Eye Group in East Melbourne, Victoria, Australia and Ramathibodi Hospital and Srinagarind Hospital in Thailand, to participate in the study.

Key Points: 
  • FREMONT, CA, Sept. 09, 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 a new clinical site in Australia has been selected to participate in the Phase II clinical study of Vitargus, the first bio-degradable vitreous substitute to facilitate retina re-attachment surgery.
  • We are pleased to confirm that the Sydney Eye Hospital will join our Phase II clinical study.
  • 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 Vitargus, the company intends to conduct the clinical trials through Phase III at various locations throughout the globe.

ABVC BioPharma Provides Vitargus® Update

Retrieved on: 
Thursday, August 18, 2022

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.

Key Points: 
  • In parallel, Vitargus Phase II Study protocol documents have been submitted to the Australian Bellberry Human Research Ethics Committee (HREC).
  • 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 Vitargus, the company intends to conduct the clinical trials through Phase III at various locations throughout the globe.
  • The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

ABVC BioPharma Provides Vitargus® Update

Retrieved on: 
Tuesday, August 2, 2022

FREMONT, CA, Aug. 02, 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 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.

Key Points: 
  • FREMONT, CA, Aug. 02, 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 Ethics Committee (EC) of Srinagarind Hospital, Khon Kaen University of Thailand approved the Vitargus Phase II Clinical Study Protocol (ABV-1701-02).
  • In addition, Vitargus Phase II Clinical Study protocol documents are now under review by the Australian Bellberry Human Research Ethics Committee (HREC).
  • ABVC BioPharma is a clinical-stage biopharmaceutical company with an active pipeline of six drugs and one medical device (ABV-1701/Vitargus) under development.
  • The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

ABVC BioPharma Provides Vitargus® Update

Retrieved on: 
Thursday, June 30, 2022

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.

Key Points: 
  • 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.
  • 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 Vitargus, the company intends to conduct the clinical trials through Phase III at various locations throughout the globe.
  • The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

ABVC BioPharma Selects Additional Vitargus® Phase II Study Sites

Retrieved on: 
Wednesday, January 5, 2022

Fremont, CA, Jan. 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 two clinical sites in Thailand have been selected to participate in the Phase II clinical study of Vitargus®, the first bio-degradable vitreous substitute intended to facilitate retina re-attachment surgery. The new sites, located at the Ramathibodi Hospital at Mahidol University and the Srinagarind Hospital at Khon Kaen University, will join two planned Australian sites already selected to participate in the study. The Company expects the Thailand Food and Drug Administration (“FDA”) and the Australian Therapeutic Goods Administration to approve the study sites and principal investigators in Q1 of 2022 with first patient enrollments beginning during Q2 of 2022.

Key Points: 
  • Fremont, CA, Jan. 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 two clinical sites in Thailand have been selected to participate in the Phase II clinical study of Vitargus, the first bio-degradable vitreous substitute intended to facilitate retina re-attachment surgery.
  • The new sites, located at the Ramathibodi Hospital at Mahidol University and the Srinagarind Hospital at Khon Kaen University, will join two planned Australian sites already selected to participate in the study.
  • During the year, we intend to keep big pharma companies that have expressed an interest in distributing Vitargus apprised of the study data as it becomes available.
  • For Vitargus, the Company intends to conduct the clinical trials through Phase III at various locations throughout the globe.