EPEIUS WINS FDA GRANT FOR TRIALS OF TUMOR-TARGETED GENE THERAPY

Epeius Biotechnologies announced it has received a R01 grant from the FDA to assist in the evaluation of a Phase I/II clinical trial using Rexin-G for advanced or metastatic pancreatic cancer. The ongoing clinical study, centered at the Mayo Clinic, will examine the safety and potential efficacy of repeated intravenous infusions of Rexin-G, the first tumor-targeted gene delivery vehicle, in the treatment of intractable pancreatic cancer.

Rexin-G, the company's lead gene therapy product, has received orphan drug status based on demonstrations of single-agent efficacy in this type of cancer. Designed to function in the context of the human circulatory system, Rexin-G seeks out, accumulates in and selectively delivers a tumor-killing designer gene to primary and metastatic cancers that have spread throughout the body.

Rexin-G has recently been approved for the treatment of all solid tumors in the Philippines and is currently in clinical trials in the U.S.