Fremont, CA - (NewMediaWire) - November 02, 2022 - 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 IRBapproval 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.
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Leeds Chow – Chief Financial Officer