The U.S. FDA has granted Orphan Drug Designation (ODD) to GHHCC (antroquinonol) for the treatment of hepatocellular carcinoma (HCC).  Antroquinonol is the pure compound extracted from Antrodia camphorata discovered and developed by a Taiwanese biotechnology company, GoldenBiotech Corp.  This ODD marks the third ODD the company received in 2015.  The other two ODD indications are pancreatic cancer and acute myeloid leukemia.  Although HCC is an uncommon type of cancer, it is the most common primary malignancy of the liver in adults.  It is associated with alcohol-related cirrhosis and hepatitis B/C virus infection.  Surgical resection offers the best treatment option.  However, the tumors are often inoperable and chemo-insensitive representing a challenge in managing this group of patients.  GoldenBiotech has already completed a Phase I trial and is conducting a Phase II trial with antroquinonol in non-small cell lung cancer patients.


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