Monotherapy Reveals Biological Activity Without Toxicity in Breast Cancer

Epeius Biotechnologies achieved favorable results in an ongoing Phase I/II study of Rexin-G for metastatic breast cancer unresponsive to conventional chemotherapy.

Interim results of the study of targeted gene delivery in vivo showed that intravenous infusions of Rexin-G demonstrated significant biological activity without toxicity in patients with rapidly progressive, chemo-resistant breast cancer. After the general safety of repeated infusions of the drug was documented, the FDA approved intrapatient dose escalations to gain better tumor control.

The goal of the trial is to confirm the overall safety of Rexin-G and to determine the optimal dosing regimen that would document the significant clinical benefits required to support a Phase II pivotal study, the company said.