Cedars-Sinai Medical Center Joins Phase I Clinical Study of ABVC BioPharma’s Medication for Treating Depression in Cancer Patients
02 November 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
the Cedars-Sinai Medical Center (CSMC, West Hollywood CA)
Institutional Review Board (IRB) has approved their
institution joining the Phase I study of ABV-1601 for treating
depression in cancer patients. The Principal Investigator of the
CSMC study will be Dr. Scott A. Irwin, MD, PhD., an eminent
Professor of Psychiatry & Behavioral Neurosciences.
The Phase I study is open label and will be conducted with 12
cancer patients with moderate to severe depressive symptoms. The
main objective of the study is to evaluate the safety of PDC-1421,
the primary active ingredient in ABV-1601. The second objective is
to determine the most effective dosages for a randomized,
double-blind, non-inferiority Phase II trial of PDC-1421 that ABVC
expects to initiate in 2023. The Company then intends to compare
results of the Phase II study of ABV-1601 to Wellbutrin XL, a
commonly used medicine to treat cancer patients suffering with
depression.
“We are delighted to receive IRB approval from Cedars-Sinai
Medical Center, a prestigious hospital in the United States, for
the Phase I study of ABV-1601 for depression in cancer patients,”
said Dr. Howard Doong, ABVC BioPharma’s chief executive officer.
“We can now schedule the site initiation visit (SIV) in November or
December of this year.”
According to Annals of Oncology 29:101m 2018, 40% to 60% of all
cancer patients suffer emotional distress needing clinical
attention and a formal diagnosis of psychiatric disorder can be
made in about 25% to 30%.
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 Chow – Chief Financial
Officer510-668-881press@ambrivis.com
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