SAN MARINO, Calif. — Epeius Biotechnologies (www.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 combination with one or more toxic agents in order to achieve even marginal results.
The dividends for the cancer patient can now be measured in terms of overall survival, which is considered to be the gold standard in terms of evaluating efficacy.
About Epeius Biotechnologies
Rexin-G(R) is commercially available for the treatment of all solid tumors in the Republic of the Philippines, and has “fast track status” as a treatment for pancreatic cancer in the United States. Epeius Biotechnologies Corporation is a privately held biopharmaceutical company dedicated to the advancement of genetic medicine with the development and commercialization of its high-performance gene delivery systems. To learn more about ongoing clinical trials, licensing and corporate partnering opportunities, please contact Dr. Erlinda M. Gordon at egordon@epeiusbiotech.com, or visit www.epeiusbiotech.com .
