TARGETED GENE DELIVERY IN VIVO: Rexin-G Monotherapy Reveals Significant Biological Activity without Toxicity in Chemo-Resistant Metastatic Breast Cancer (ASCO 2008)

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SAN MARINO, Calif., May 22 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies announced today the promising results of an on-going United States-based Phase I/II study of Rexin-G(R) for metastatic breast cancer that is refractory to conventional chemotherapy (J Clin Oncol 26:14509, 2008). This clinical trial employed intra-patient dose-escalations of Rexin-G given i.v. two to three times a week for 4 weeks, with doses ranging from 2 x 10e11 cfu to 6 x 10e11 cfu per week. The goal of the adaptive trial design is to confirm the over-all safety of Rexin-G and to determine the optimal dosing regimen for Rexin-G that would document the significant clinical benefits required to support a Phase II pivotal study.

Caption: Rexin-G cancer clinical trialThe interim 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 rapidly progressive chemo-resistant breast cancer. Once the general safety of repeated infusions of Rexin-G was documented, the FDA approved across the board intra-patient dose-escalations in order to gain better tumor control.

These escalating doses of Rexin-G were associated with stabilization of disease, using both RECIST and International PET criteria, significant reductions in CA 15.3 levels, a median progression-free survival of 6 months (RECIST) and a median over-all survival of greater than 7 months with all patients surviving at the 8-month follow-up period. No dose-limiting toxicity was observed, even at the higher doses of Rexin-G, thus confirming that repeated infusions of Rexin-G are safe and well-tolerated.

According to Dr. Erlinda M. Gordon, Medical Director of Epeius, "The importance of these dose-escalation studies-which clearly establish safety before escalating to more potent tumoricidal levels-is a primary concern in the development of a new genetic medicine like Rexin-G."

Taken together with the results of previous studies, the current on-going Phase I/II study confirms the exemplary safety and therapeutic potential of Rexin-G in chemotherapy-resistant metastatic breast cancer.

For more information about Rexin-G, on-going clinical trials in the USA and abroad, and/or Epeius pathotropic (disease-seeking) gene delivery systems, please contact Dr. Erlinda M. Gordon at

Epeius Biotechnologies:

Rexin-G is a reg. trademark.

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REFERENCES: pharma gene delivery systems, Epeius Biotechnologies Corporation, Epeius Biotechnologies Corporation, Rexin-G for metastatic breast cancer, pathotropic disease-seeking gene delivery systems, Dr. Erlinda M. Gordon, ASCO 2008, refractory to conventional chemotherapy, RECIST and International PET criteria, news, press release from Epeius Biotechnologies Corporation, May 22, 2008, Drugs and Pharmaceuticals, , , , , TARGETED GENE DELIVERY IN VIVO: Rexin-G Monotherapy Reveals Significant Biological Activity without Toxicity in Chemo-Resistant Metastatic Breast Cancer (ASCO 2008)