SAN MARINO, Calif. — Epeius Biotechnologies Corporation announced today the expansion of ongoing clinical trials using Rexin-G(TM) in the United States to include breast cancer and all types of sarcomas that have failed standard chemotherapy. Following on the heels of their landmark clinical trials in the United States and abroad, the US 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.
Rexin-G is the world’s first tumor-targeted nanomedicine – a targeted gene delivery system that seeks out and destroys both primary tumors and metastatic cancers that have spread throughout the body. Delivered by simple intravenous infusion, Rexin-G has demonstrated unprecedented single-agent efficacy against a broad spectrum of solid tumors where chemotherapy, radiotherapy and other targeted therapies have failed.
According to Dr. Erlinda M. Gordon, M.D., Medical Director of Epeius, “In advancing these new trials in the United States, we are keeping our promise to the Food and Drug Administration, who originally granted us permission to make Rexin-G available to foreign countries with the proviso that we would “open clinical trials in the United States as soon as practicable.”
With more than three years of clinical experience with Rexin-G in an increasing number of otherwise intractable cancers in the Philippines, Japan and the US, we have gained valuable insights into the general safety, optimal dosing parameters, and best treatment regimens that provide the greatest benefits for the cancer patient without compromising safety. In addition, we have brought the formulation of Rexin-G to its highest clinical potency, enabling treatments of only two or three simple infusions per week.”
The clinical trials of Rexin-G for breast cancer and sarcoma will initially be centered in San Marino CA, where Epeius Biotechnologies Corp. has its headquarters, and in Santa Monica CA at the Sarcoma Oncology Center. Dr. Sant P. Chawla, M.D., who trained at the University of Texas M.D. Anderson Cancer Center, is a renowned expert on malignant sarcomas, and has agreed to serve as Principal Investigator (PI) for both clinical trials. With the global demand for Rexin-G increasing, Epeius is actively engaged in the development of additional trials and the establishment of treatment centers in the United States and around the world.
For further up-to-date information concerning the clinical trials, treatment options, and/or eligibility requirements, interested persons may contact Dr. Gordon at emgordon@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, to 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]Erlinda Gordon, clinical trials RexinG, breast cancer and sarcomas, Epeius Biotechnologies Corporation, biopharmaceutical company[/tags]
