The U.S. Food and Drug Administration’s Office of Orphan Products Development has granted Orphan Drug Designation to GenSpera’s lead candidate G-202 for the treatment of hepatocellular carcinoma (HCC), the most common form of primary liver cancer.
G-202, currently in a phase 2 clinical trial for patients whose disease has worsened on standard therapy for HCC, is expected to demonstrate efficacy in a wide range of tumor types.
By receiving Orphan drug designation for G-202, GNSZ is granted seven-year U.S. market exclusivity if the company complies with certain FDA specifications. Additional incentives include tax credits for clinical trial expenses, access to funding to support the clinical studies, and a possibility of being exempt from FDA user fees.
“We are excited to receive orphan drug status for G-202, which we feel further enhances the value of the company’s proprietary property once regulatory approval is achieved,” Craig Dionne, PhD, GNSZ’s CEO and president stated in the press release. “We are optimistic that our phase 2 clinical trial with G-202 will soon indicate significant potential benefits for HCC patients.”
For more information, visit www.genspera.com
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