Pharma Focus Asia

OBI Pharma Granted FDA Orphan Drug Designation for OBI-3424 for the Treatment of Hepatocellular Carcinoma (HCC)

Monday, July 09, 2018

OBI Pharma, Inc., a Taiwan biopharma company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for OBI-3424 for the Treatment of Hepatocellular Carcinoma (HCC). OBI-3424 is a first in class DNA alkylating cancer therapeutic agent targeting aldo-keto reductase 1C3 (AKR1C3) overexpressing cancers.

A Phase 1/2 study of OBI-3424 in patients with solid tumors, including hepatocellular carcinoma (HCC) and castrate-resistant prostate cancer (CRPC), has commenced enrollment at the University of Texas M.D. Anderson Cancer Center.

Amy Huang, General Manager of OBI Pharma, noted, "The orphan drug designation for OBI-3424 by the FDA is a significant step in the development of this drug candidate. OBI-3424 is intended to treat a devastating form of Liver Cancer with limited therapeutic options. We are excited that the FDA has recognized the need to develop novel targeted therapeutic agents such as OBI-3424 in the fight against this disease."

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