ABVC BioPharma Provides Vitargus® Update - Phase II Vitargus® Study Protocol Received Thai FDA Approval
18 November 2022 - 12:30AM
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). Import licenses
for the Vitargus medical device and SF6-Gas used as a comparator in
the clinical study were issued to both TH001 and TH002 study sites
in Thailand on November 2, 2022.
Vitargus medical devices and SF6-Gas comparators will be shipped
to Ramathibodi Hospital, Mahidol University located in Bangkok
(TH001) and Srinagarind Hospital, Khon Kaen University located in
Khon Kaen Province (TH002) in preparation for the Site Initiation
Visit (SIV) of the study planned to begin before the end of 2022.
It is expected that a total of 20 or more patients undergoing
vitreo-retinal surgery will be included in the study at the two
selected sites.
“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. “We also note that
our two Australian sites are soon expected to receive the green
light from the Australian Therapeutic Goods Administration (TGA)
allowing us to proceed with the Australian study in early 2023.”
Dr. Doong further noted that “more study sites will be added in
other countries later in 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 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:Leeds ChowCFOEmail: leedschow@ambrivis.com
ABVC BioPharma (NASDAQ:ABVC)
Historical Stock Chart
From Mar 2024 to Apr 2024
ABVC BioPharma (NASDAQ:ABVC)
Historical Stock Chart
From Apr 2023 to Apr 2024