GenSpera announced that the FDA has been granted Orphan Drug Designation to its lead candidate, G-202, for the treatment of hepatocellular carcinoma (HCC), the most common form of primary liver cancer.
G-202 is activated by the enzyme PSMA, which is found at elevated levels in prostate cancer and in the vasculature of almost all solid tumors. Therefore, G-202 is expected to be effective in a wide variety of tumor types.
Data from the G-202 Phase 1b program in solid tumor patients demonstrated that G-202 is well-tolerated with prolonged disease stabilization. This was observed in several hepatocellular carcinoma patients whose disease had previously worsened on standard therapy. Currently, a Phase 2 clinical trial with G-202 for patients with HCC whose disease has worsened on standard therapy for HCC is underway.
For more information call (210) 479-8112 or visit www.genspera.com.