ABVC BioPharma Selects Additional Vitargus® Phase II Study Sites
January 05 2022 - 8:30AM
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.
“With the additional Thailand sites, we are pleased to be well
along in our plan to have at least four countries included in the
Vitargus Phase II study by the end of 2022, as we also continue our
discussions with the United States FDA to hopefully include U.S.
patients in the study later this year or in 2023,” said Dr. Howard
Doong, Chief Executive Officer of the Company. “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.”
Early clinical studies indicate that Vitargus® has unique
properties that eliminate the need for post-surgery patient
face-down positioning and significantly improves recovery period
patient comfort and visual acuity compared to existing products.
The objective of the Phase II study, “A Prospective Multi-Site
Randomized Controlled Clinical Investigation of the Safety and
Effectiveness of the ABV-1701 Ocular Endotamponade (OE),” is to
demonstrate the safety and efficacy of Vitargus® as compared to SF6
Gas OE, now commonly used for retina re-attachment. The incident of
retinal detachment in Thailand is about 3% by the age of 851,
compared to the incident of retinal detachment in Australia, which
affects about 1% of the population2.
According to iHealthcareAnalyst, Inc., the global market
for retinal surgery devices is expected to reach $3.7 billion by
2027, driven by a rising geriatric population worldwide.
1 Chokboonpiem J, Akrapipatkul, and Wongkumchang
N; Visual field recovery after pars plana vitrectomy procedure for
rhegmatogenous retinal detachment. EyeSEA 2017; 12(1): 50-56.
Retrieved
from https://he01.tci-thaijo.org/index.php/eyesea/index.
2 Retinal detachment. Chatswood Eye
Specialists. Retrieved from
https://www.chatswoodeye.com/retinal-detachment/.
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
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