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ABVC BioPharma Provides 2023 Pipeline Update
FREMONT, CA, Feb. 28, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical stage biopharmaceutical company developing
About this update from Abvc Biopharma, Inc.
[{"type":"text","content":"FREMONT, CA, Feb. 28, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today provided an update to drug and medical device developments expected in 2023. Major Depressive Disorder: ABVC’s MDD medicine, ABV-1504, has successfully completed Phase II at the Stanford University Medical Center and five major medical centers in Taiwan. Later this year, with the help of Dr. Maurizio Fava and Dr. Thomas Laughren, the company expects to conclude discussions with the US FDA on acceptable protocols for Phase III trials for MDD, allowing ABVC to seek potential distribution partners active in manufacturing and distributing Central Nervous System (CNS) medicines. Dr. Fava is Psychiatrist-in-Chief of the Massachusetts General Hospital (MGH), executive director of the Clinical Trials Network and Institute, (CTNI), 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. Dr. 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 approvals before U.S. commercialization. ADHD: The company’s ADHD medicine ABV-1505, is currently in Phase II, part 2, clinical trials at five prestigious medical centers in Taiwan. In addition, in the next several months the part 2 study will begin at the University of California, San Francisco (UCSF) Medical Center. This study is expected to eventually enroll approximately 100 patients in Taiwan and the United States. Since results of the first subject treated in Taiwan were reported on May 10, 2022, 42 subjects have now been enrolled in the study from a total of 64 subjects screened. 36 of the enrolled participants have already completed the 8-week treatment in accordance with the study design. Cancer Patient Depr...