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OBI Pharma receives FDA orphan drug designation for HCC therapy
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OBI Pharma received FDA orphan drug designation for OBI-3424 for the treatment of hepatocellular carcinoma, according to a press release.
OBI-3424 is a first-in-class DNA alkylating cancer therapeutic designed to target aldo-keto reductase 1C3 overexpressing cancers.
“The orphan drug designation for OBI-3424 by the FDA is a significant step in the development of this drug candidate,” Amy Huang, general manager of OBI Pharma, said in the release. “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.”
Researchers at the University of Texas MD Anderson Cancer Center have initiated enrollment of patients with solid tumors from HCC or castrate-resistant prostate cancer in a phase 1/2 study of OBI-3424.
Reference: www.obipharma.com