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news.Epeius Biotechnologies Corporation has initiated a phase I clinical trial to test the safety of its developmental pancreatic cancer drug, Rexin-G, the first tumor-targeted gene therapy vector to gain orphan drug designation from the FDA.
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A maximum of 24 eligible patients will be entered into this dose-seeking study, which will test the safety of increasing doses of Rexin-G, given intravenously, in patients with advanced or metastatic pancreatic cancer who have failed standard chemotherapy.
Rexin-G is a tumor-targeted gene therapy vector that contains a “killer” gene that blocks the action of the human cyclin G1 gene, which plays an important role in cancer cell growth. When injected into a vein, the Rexin-G vector seeks out and accumulates in cancerous tumors, thereby increasing the concentration of the drug in the cancerous tumors and not in normal neighboring organs.
Recently, Epeius was granted the approval to provide “Expanded Access to Rexin-G” by the Philippine Bureau of Food and Drugs for pancreatic and breast cancer. This means that Rexin-G is now available on a limited commercial basis for the treatment of pancreatic and breast cancer in Manila, Philippines.