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ASEAN News: Epeius Biotechnologies Gains Commercial Approval for Rexin-G, a Tumor-Targeted Gene-Based Medicine for Metastatic Cancer

Published: Mon, 17 Dec 2007, 14:46:32 EDT

Edited by Carly Zander

SAN MARINO, Calif. - Dec. 17 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies Corporation announced today that the company has received a Certificate of Product Registration for Rexin-G(R) from the Philippine Bureau of Food and Drugs (BFAD), enabling the commercialization of its lead product as a safe and effective treatment for a broad spectrum of intractable cancers. Developed as a tumor-targeted anticancer agent, that actively seeks out and destroys metastatic cancers, Rexin-G exhibits unprecedented single-agent efficacy where other agents, including targeted biologics, have failed. Moreover, Rexin-G has established an exemplary record of clinical safety, virtually eliminating the systemic toxicities routinely encountered with chemotherapies, thus enhancing quality of life.

This recent regulatory approval and licensure of Rexin-G in the Philippines is noteworthy in that Rexin-G(R) is among the first gene-based medicines to be approved anywhere in the world, and remarkable in that it is the first targeted gene delivery system ever developed that actually works in humans. However, such individual accomplishments are rarely heralded by the intrepid physicians and scientists at Epeius Biotechnologies whose mission runs contrary to so many blue-sky biotechnology companies that are quick to "sell (i.e., promote) the story," only to disappoint the patients, who remain the most vulnerable of society.

According to Dr. Frederick L. Hall, President and CEO of Epeius, "It is most fitting that Rexin-G receives its first product registration in the Philippines which brought forth the stellar physician-scientist whose drive and determination to engineer a better medicine made Rexin-G possible, and also it was first in the Philippines where the dedicated clinicians, oncologists, regulatory authorities, and medical institutions worked tirelessly for years to bring this targeted genetic medicine to the bedside."

Now that Rexin-G is commercially available to Philippine physicians and their patients, and to a host of medical tourists from the United States, Europe, and Japan, the next step is to expand its availability to these countries and to ASEAN countries that share cooperative affiliations with the Philippines. Epeius Biotechnologies has intensified its efforts to gain product registration in the United States-following several years of safety studies in the USA, Epeius has formally opened three advanced Phase I/II trials in San Marino and Santa Monica, California, for chemo-resistant pancreatic cancer, breast cancer, and sarcoma. Based again on unprecedented single-agent efficacy and over-all safety, the U.S. FDA recently approved a Phase II Registration Protocol for osteosarcoma which includes participation of children and adolescents.

For additional information about ongoing clinical trials in the United States, contact our Medical Director, Dr. Erlinda M. 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 lead products and proprietary targeted delivery systems. Credited with innovations ranging from gene discovery, to designer therapeutic genes, to pathotropic (disease-seeking) targeting, to ultra 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.

Meanwhile, rapid advances in clinical drug development provide Epeius with a unique opportunity for early revenues from the sale of its lead product to the Philippines and reciprocating ASEAN 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 and/or clinical trials, please visit www.epeiusbiotech.com.

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ADDITIONAL NEWS FROM Epeius Biotechnologies Corporation

» Phase I/II Study of Targeted Gene Delivery In Vivo - Intravenous Infusions of REXIN-G » Targeted Gene Delivery Signals Cancer Vaccination in Vivo » TARGETED GENE DELIVERY IN VIVO: Rexin-G Monotherapy Reveals Significant Biological Activity without Toxicity in Chemo-Resistant Metastatic Breast Cancer (ASCO 2008) » ASCO 2008: Tumor-Targeted Rexin-G Demonstrates Dose-Dependent Anti-Tumor Activity without Toxicity in Metastatic Pancreatic Cancer » Interim Analysis of Phase I/II Study of Rexin-G Confirms Efficacy with No Dose Limiting Toxicity in Metastatic Pancreatic Cancer

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