Prestigious Researchers to Provide Consulting Services in Connection with ABVC BioPharma's Depression Medicines
May 23 2022 - 7:30AM
via NewMediaWire -- ABVC BioPharma, Inc. (NASDAQ: ABVC),
a clinical stage biopharmaceutical company developing therapeutic
solutions in oncology/hematology, CNS, and ophthalmology, today
announced that Dr. Maurizio Fava and Dr. Thomas Laughren have
agreed to provide consulting services in connection with clinical
studies of its central nervous system medicines designed to
alleviate symptoms of Major Depression Disorder (MDD) and Adult
Depression Hyperactive Disorder (ADHD). The company’s MDD medicine
has successfully completed Phase II clinical studies which were
accepted by the U.S. Food & Drug Administration in October
2020. Its ADHD medicine successfully completed Phase II, part 1 and
is initiating part 2 at the University of California, San Francisco
Medical Center as well as at five clinical study sites in Taiwan.
Dr. Fava is Psychiatrist-in-Chief of the
Massachusetts General Hospital (MGH), executive director of the
Clinical Trials Network and Institute, (MGH), associate dean for
clinical and translational research and the Slater Family Professor
of Psychiatry at Harvard Medical School. He is a world leader in
the field of depression, has edited eight books and authored or
co-authored more than 900 original articles published in medical
journals with international circulation, articles which have been
cited more than 95,000 times in the literature and with an h index
of over 150. Dr. Fava obtained his medical degree from the
University of Padova School of Medicine and completed residency
training in endocrinology at the same university. He then moved to
the United States and completed residency training in psychiatry at
MGH. He founded and was director of the hospital’s Depression
Clinical and Research Program from 1990 until 2014. Under Dr.
Fava’s direction, the Depression Clinical and Research Program
became one of the most highly regarded depression programs in the
country, a model for academic programs that link, in a
bi-directional fashion, clinical and research work. In 2007, he
also founded and is now the executive director of the MGH
Psychiatry Clinical Trials Network and Institute, the first
academic CRO specialized in the coordination of multi-center
clinical trials in psychiatry.
Dr. Thomas Laughren is Director of
Regulatory for the MGH Psychiatry Clinical Trials Network and
Institute, providing consultations on psychiatric and neurologic
drug development. He retired as Division Director for the Division
of Psychiatry Products, Center for Drug Evaluation and Research at
FDA in December 2012. As Division Director, Dr. Laughren oversaw
the review of all psychiatric drug development activities
conducted under INDs and the review of all NDAs and supplements for
new psychiatric drug claims. Prior to coming to FDA in September
1983, Dr. Laughren was affiliated with the VA Medical Center in
Providence, RI, and was on the faculty of the Brown University
Program in Medicine. He received his medical degree from the
University of Wisconsin in Madison, Wisconsin, and completed
residency training in psychiatry at the University of Wisconsin. He
has authored and co-authored many papers and book chapters on
regulatory and methodological issues pertaining to the development
of psychiatric drugs and is a frequent speaker at professional
meetings on these same topics. Dr. Laughren has received numerous
awards for his regulatory accomplishments.
“We are pleased that Doctors Fava and Laughren
have agreed to provide their invaluable advice as we move our MDD
and ADHD medicines through the clinical study regulatory process,”
said Dr. Howard Doong, Chief Executive Officer of ABVC BioPharma.
“Their experience with psychiatric medicine and the regulatory
process are unmatched in the United States today."
About ABVC BioPharmaABVC 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 StatementsThis 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 PengPhone: +1
646-677-1872Email: Lucy.Peng@icrinc.com
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