Clinical Trial for Pancreatic Cancer Opens at Mayo Clinic Using Tumor-Targeted Gene Therapy Vector

Main Category: Pancreatic Cancer
Article Date: 20 Jul 2005 - 9:00 PDT

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Epeius Biotechnologies Corporation announced that a Phase I clinical trial has opened at Mayo Clinic Cancer Center, Rochester, Minnesota to test the safety of Rexin-G(TM), the first tumor-targeted gene therapy vector to gain Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.

The clinical protocol has passed the rigorous reviews of the FDA, the NIH/Recombinant Advisory Committee, and the Institutional Review Board of Mayo Clinic. A maximum of 24 eligible patients will be entered into the study. Interested persons may call Mayo Clinic Cancer Center at Tel. No.: 507-538-7623 to determine eligibility and potential participation in the study.

ABOUT THE REXIN-G CLINICAL TRIAL:

This is a dose-seeking study that will test the safety of increasing doses of Rexin-G(TM), given intravenously, in patients with advanced or metastatic pancreatic cancer who have failed standard chemotherapy. Rexin-G(TM) is a tumor-targeted gene therapy vector that contains a "killer" gene that blocks the action of the human cyclin G1 gene. Cyclin G1 is a cell cycle control element that plays an important role in cancer cell growth. When injected into a vein, the Rexin-G(TM) vector seeks out and accumulates in cancerous tumors, therefore, increasing the concentration of the drug in the cancerous tumors and not in normal neighboring organs.

ABOUT EPEIUS:

Epeius Biotechnologies Corporation is a privately held biopharmaceutical company that was formed to develop and commercialize the first truly effective Targeted Gene Delivery System (TDS) that can be injected directly into a vein to deliver genetic medicine preferentially to cancerous tumors that have spread throughout the body (metastatic cancer). Recently, Epeius was granted the approval to provide "Expanded Access to Rexin-G(TM)" by the Philippine Bureau of Food and Drugs for pancreatic and breast cancer. This means that Rexin-G(TM) is now available on a limited commercial basis for the treatment of pancreatic and breast cancer in Manila, Philippines.

http://www.epeiusbiotech.com

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