From Send2Press® Newswire » Story Permalink
Drugs and Pharmaceuticals News
Clinical Studies Validate Cancer Gene Delivery Platform:
Landmark Publication Confirms Rexin-G Effectively Targets
Metastatic Cancers and Improves Patient Survival
Edited by Carly Zander
Mon, 22 Jun 2009, 12:45:51 EDT
SAN MARINO, Calif., June 22 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies (epeiusbiotech.com) stuns the medical
and scientific communities with a dramatic demonstration of single-agent efficacy with its lead product, Rexin-G, for metastatic
cancer. The landmark article (accessible online as of June 16, 2009 in Molecular Therapy, the Official Journal of The American
Society of Gene Therapy, www.nature.com/mt/) documents the results of two related studies using Rexin-G, a tumor-targeted
anti-cancer agent designed to seek-out and destroy metastatic cancers that have spread throughout the body, while sparing
normal cells and healthy tissues and organs.
Following the FDA's designation of Rexin-G as an Orphan Drug for the treatment of soft
tissue sarcoma and osteosarcoma in 2008, the results of these two independent studies
represent a major step toward gaining Accelerated Approval of Rexin-G for osteosarcoma
in the United States.
"It took several years of painstaking safety studies, followed by gradual, progressive dose
escalations, to the point where tumor control was consistently demonstrated, said Dr.
Erlinda M. Gordon, Medical Director of Epeius Biotechnologies.
Yet the progressive development strategy has finally paid off with real dividends: (1) By
establishing the overall safety of the tumor-targeted gene delivery platform first and
foremost, (2) By establishing critical pharmacological thresholds of bioactivity and dose-dependent efficacy for a new class of
biological anti-cancer agents in otherwise intractable cancers, and (3) By validating the potential of Rexin-G to control
metastatic cancer with single-agent efficacy, whereas other targeted therapies must be used in