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.
According to a Brand Essence Research Report, antidepressant market was valued at $13.7 Billion in 2018 and expected to reach $15.9 Billion by 2025 with a CAGR of 2.2% over the forecast period (https://www.medgadget.com/2019/08/antidepressant-drugs-market-size-share-current-trends-opportunities-competitive-analysis-and-forecast-to-2019-2025.html).
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, 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.
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. None of the outcomes expressed herein are guaranteed. 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:
Tom Masterson
Email: tmasterson@allelecomms.com
