Fremont, CA - (NewMediaWire) - April 10, 2023 - ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical-stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced that the Phase 1 Site Initiation Visit(SIV) of ABV-1601 was successfully conducted at Cedars-Sinai Medical Center (CSMC) in West Hollywood,California on March 31, 2023. The SIV was an organized meeting to discuss Phase I study protocol with the principal investigator, Scott A. Irwin, M.D., Ph.D. and begin training clinical personnel.
ABV-1601,the Phase I open-label study 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, in cancer patients.
“We are pleased to see the ABV-1601 Site Initiation Visit successfully completed at Cedars-Sinai Medical Center (CSMC) with Dr. Scott Irwin M.D., Ph.D. and his clinical team,” said Dr. Howard Doong, Chief Executive Officer of the Company. “To facilitate the patient enrollment, three investigators from Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute will also join this study.”
ABVC expects to initiate the Phase II study of ABV-1601 in the fourth quarter of 2023 and then compare the results to Wellbutrin XL, a commonly used medicine to treat cancer patients suffering with depression. The Phase II study is to determine the most effective dosages using a randomized, double-blind, non-inferiority trial protocol of PDC-1421 vs. Wellbutrin XL.
The Company’s previous clinical study of PDC-1421, the primary active ingredient in ABV-1504 as well, included a Phase II study of ABV-1504 for the treatment of patients with major depressive disorder (MDD). The study demonstrated a clinically meaningful 13.2-point reduction in Montgomery-Asberg Depression Rating Scale (MADRS) in the Intention-To-Treat (ITT) high-dose group, compared to a 9.2-point reduction in the placebo group. The study also showed the drug products, both high and low doses, were safe and well tolerated with no serious adverse event (SAE) over the 6-week treatment period.
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, the company utilizes in-licensed technology from its network of world-renowned research institutions to conduct proof-of-concept trials through Phase II of clinical development. The company’s network of research institutions includes Stanford University, University of California at San Francisco, and Cedars-Sinai Medical Center. For Vitargus®, the company intends to conduct global clinical trials through Phase III.
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