Clinical Trial Using Rexin-G(TM), a Targeted Injectable Gene Delivery System
SAN MARINO, Calif. — Epeius Biotechnologies Corporation announced today that an advanced Phase I/II clinical trial using intravenous Rexin-G(TM) for pancreatic cancer that is refractory to standard chemotherapy will open in the summer of 2007 in Los Angeles, California. Rexin-G is the world’s first tumor-targeted injectable gene delivery system that is designed to seek out and destroy both primary tumors and metastatic cancers that have spread throughout the body. Recently, the FDA granted Orphan Drug Status for Rexin-G for the treatment of pancreatic cancer while the Philippine BFAD granted Expanded Access Use of Rexin-G for the treatment of all chemo-resistant solid tumors.
According to Erlinda M. Gordon, M.D., Medical Director of Epeius, the upcoming clinical trial incorporates a Phase II component that will evaluate the efficacy of Rexin-G using an adaptive trial design. Each treatment cycle will be six weeks: four weeks of treatment and two weeks of rest. Unlike a standard Phase I protocol, eligible patients may have repeat cycles after the safety data and objective tumor response/s are recorded.
Continued Rexin-G treatment will enable the targeted nanomedicine to catch up with tumor growth, halt disease progression, and reduce tumor burden with a new dosing paradigm (called “the Calculus of Parity”) described by Gordon et al. (Int’l J Oncol, Vol. 29, pp. 1053-1064, 2006). The treatment strategy is to achieve tumor control as quickly as safely possible. The goal of the adaptive trial design is to confirm the overall 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 registration protocol.
The clinical trial using Rexin-G for pancreatic cancer is the third of three advanced Phase I/II protocols that will be conducted by Sant P. Chawla, M.D., in the Epeius Clinical Research Unit in San Marino, CA, and in the Sarcoma Oncology Center in Santa Monica, CA. Two other trials for sarcoma and breast cancer have been approved by the FDA. Dr. Sant P. Chawla, who trained at the University of Texas M.D. Anderson Cancer Center, is a renowned expert in sarcoma, and has agreed to serve as principal investigator for all three clinical trials. For further information concerning these clinical trials, please contact Dr. Gordon at egordon@epeiusbiotech.com.
About Epeius Biotechnologies
Epeius Biotechnologies Corporation is a privately held biopharmaceutical company dedicated to the advancement of genetic medicine with the development and commercialization of its proprietary targeted delivery systems.
Credited with innovations ranging from oncogene discovery, to designer therapeutic genes, to pathotropic (disease-seeking) targeting, to high-performance vector engineering, advanced biopharmaceutical manufacturing and bioprocess development, Epeius Biotechnologies is well positioned to “launch” its enabling platform technologies for the benefit of cancer patients worldwide.
Rapid advances in clinical drug development provide Epeius with a unique opportunity for early revenues from the exportation and sale of its lead product to the Philippines and reciprocating Southeast Asian countries-thus demonstrating the high growth potential of a small biotechnology company while maintaining the lowered risk profile of a biopharmaceutical company with a high-value, late-stage product.
To learn more about Rexin-G and Epeius’ pipeline of proprietary compounds currently available for partnership or clinical trials, please visit us at http://www.epeiusbiotech.com
[tags]Epeius Biotechnologies Corporation, biopharmaceutical manufacturing, genetic medicine, designer therapeutic genes[/tags]
