ABVC BioPharma Announces Vitargus® Phase II Study Plan Approved by HREC in Australia
05 October 2022 - 11:30PM
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. 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 Stephanie OshchepkovPhone: +1 (203)
682-7175Email: Stephanie.Oshchepkov@icrinc.com
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