Epeius announces positive results from Phase I/II cancer trial

Continuing on with the planned dose-escalations of Rexin-G which began in 2005 using lower doses of Rexin-G in a Phase I safety study, the current Phase I/II study employed higher dose-escalations of Rexin-G given i.v. two to three times a week for four weeks, beginning with 8 x 10e11cfu to 6 x 10e12cfu with a goal to safely reach the point where the clinical anti-tumor activity of Rexin-G would be clearly and unequivocally demonstrated.

The results of this Phase I/II study of targeted gene delivery in vivo are very encouraging – intravenous infusions of Rexin-G demonstrated significant biological activity without toxicity in patients with progressive chemo-resistant pancreatic cancer. Once the overall safety record of repeated infusions of Rexin-G was clearly demonstrated, the FDA approved across the board intra-patient dose-escalations to gain better tumor control.

These higher doses of Rexin-G were associated with stabilization of disease, using both Recist and International Pet criteria, significant reductions in CA 19.9 levels, and an increase in median overall survival (greater than six months) which was twice that observed in the low-dose safety study. No dose-limiting toxicity was observed, even at these higher doses of Rexin-G, thus confirming that repeated infusions of Rexin-G are safe and well-tolerated.