Golden Biotech Signs Agreement with Fortrea Inc. to Request an End-of-Phase 2 (EOP2) Meeting with the US FDA

Golden Biotechnology Corp. (TPEx 4132) ("GoldenBiotech", GBC), an advanced biopharmaceutical development company, announces that it has signed an agreement with Fortrea Inc., a renowned Contract Research Organization (CRO), on May 23, 2024. Under the agreement, Golden Biotech will assign Fortrea Inc. to submit an End-of-Phase 2 (EOP2) meeting request to the FDA.

Golden Biotech's investigational new drug, Antroquinonol (HOCENA^®), in combination with standard pancreatic cancer therapy, is intended for the first-line treatment of metastatic pancreatic cancer.

The EOP2 meeting will provide an opportunity for Golden Biotech to consult with the FDA on the results of its clinical trials. The discussions will focus on the further development and the potential approval of Antroquinonol. Antroquinonol has already received orphan drug designation (ODD) from the FDA and the EC for the treatment of pancreatic cancer.