Taiwan biopharma company OBI Pharma Inc (TPEx:4174) disclosed on Monday the receipt of US Food and Drug Administration (FDA) Orphan Drug Designation for OBI-3424 for the treatment of Hepatocellular Carcinoma (HCC).
According to the company, the OBI-3424 is a first in class DNA alkylating cancer therapeutic agent targeting aldo-keto reductase 1C3 (AKR1C3) overexpressing cancers. OBI-3424 is a first-in-class novel small-molecule prodrug that selectively targets cancers overexpressing the enzyme aldo-keto reductase 1C3 (AKR1C3) and selectively releases a potent DNA alkylating agent in the presence of the AKR1C3 enzyme.
In conjunction with the approval, a Phase 1/2 study of OBI-3424 in patients with solid tumours, including hepatocellular carcinoma (HCC) and castrate-resistant prostate cancer (CRPC), has begun enrolment at the University of Texas M.D. Anderson Cancer Center, added the company.
Additionally, the company holds worldwide rights for OBI-3424 with the exception of the following countries, whose rights are held by Ascenta Pharma: China, Hong Kong, Macao, Taiwan, Japan, South Korea, Singapore, Malaysia, Thailand, Turkey and India.
Hepatocellular Carcinoma (HCC) is a form of liver cancer associated with various stages of malignant growth in the liver. It is considered a lethal cancer, with a survival rate of around 12.2% for five years and the third major leading cause of cancer-related deaths worldwide.
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