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Japanese Study Confirms Safety and Efficacy of Intravenous Rexin-G(TM) as Treatment for Diverse Metastatic Cancers

Wed, 06 Dec 2006, 13:45:00 EDT

Edited by Christopher Simmons

SAN MARINO, Calif. and TOKYO, Japan - Dec. 6 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies announced today the first results of an independent study conducted in Japan that further documents the safety and efficacy of intravenous Rexin-G in a broad spectrum of patients with chemo-resistant metastatic cancer. Although the study began in October, only two months ago, the initial reports are both encouraging and noteworthy. The lead investigator of the Japanese study, Dr. Takaki Imamura, will be presenting his findings and clinical recommendations at a special medical conference to be held in Tokyo, Japan, on December 16, 2006.

The Japanese study proceeded with caution, initially utilizing low doses of Rexin-G (Weekly Dose: 1 x 10e11 Units x 2 weeks; n=6), then rapidly advancing to examine higher doses predicted to be more effective (Weekly Dose: 4 x 10e11 Units x 2 weeks; n=9). Concerning the efficacy of Rexin-G, the results of the study revealed that 33% of patients in the low-dose group, and 56% in the higher-dose group gained significant therapeutic benefit from simple intravenous infusions. Therapeutic efficacy was achieved in a dose-dependent manner. Notable objective responses included tumor regression-confirmed by direct fiberoptic examination-in a patient with laryngeal cancer, and regression of lung metastasis-confirmed by MRI-in another patient with soft tissue sarcoma. In a group of patients with metastatic pancreatic cancer, a significant decrease in ascitic fluid accumulation, a decrease in bilirubin level and improved appetite were noted in two patients, while a significant reduction in tumor markers, relief of intestinal obstruction, relief of pain, and improved quality of life were observed in two other patients. Importantly, the Japanese study included the world's first cancer patient with overt brain metastasis to be treated with Rexin-G. This particular patient, suffering from non-small cell lung cancer with meningeal and brain metastasis, was wheelchair-bound with reduced consciousness prior to treatment, yet experienced an increase in both the level of consciousness and improved ambulation after treatment, enabling this patient to walk again with the assistance of a cane.

Concerning the overall safety of Rexin-G, all 15 patients tolerated the vector infusions well with no associated nausea or vomiting, diarrhea, mucositis, hair loss or neuropathy. There was no significant alteration in hemodynamic function, bone marrow suppression, liver, kidney or any organ dysfunction observed during the treatment period. Mild vague fatigue in ten of 15 (66%) patients and mild constipation in four of 15 (27%) patients were the only side effects noted. The absence of treatment-related adverse events further suggests that Rexin-GTM is a relatively safe therapy.

For more information on the ongoing study and the upcoming medical conference, and also for potential participation in the clinical trials, please visit Dr. Imamura's website at http://2nd-opinion.jp/sinchaku/new.htm

In a statement to the press, Dr. Erlinda Maria Gordon, Vice President of Medical Affairs of Epeius Biotechnologies Corporation commented on these landmark studies in Japan: "We are delighted to have such honorable and conscientious partners as Dr. Imamura and his colleagues in Japan, whose personal efforts have advanced the clinical development of this tumor-targeted genetic medicine decades ahead. We are pleased that Rexin-G continues to perform well-as a highly active and effective agent in a broad spectrum of refractory and chemo-resistant tumors (Int'l J Oncol, 2006). And, of course, we are proud to be part of the international efforts being made to make Rexin-G available to more cancer patients around the world."

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 tumor-targeted delivery systems. Credited with innovations ranging from oncogene discovery, to designer-gene therapy, to pathotropic (disease-seeking) targeting, to high-performance vector engineering, to advanced GMP and bioprocess development, Epeius Biotechnologies is well positioned to "launch" its enabling platform technologies for the benefit of cancer patients worldwide.

To learn more about Rexin-G and Epeius' pipeline of proprietary therapeutics currently available for partnership, please visit us at www.epeiusbiotech.com.

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ADDITIONAL NEWS FROM Epeius Biotechnologies Corporation

» Targeting Metastatic Cancer from the Inside: Epeius Biotech Reveals a New Generation of Tools for Medical Gene Delivery » Epeius Biotechnologies' Lead Product, Rexin-G for Metastatic Cancer, Aptly Highlighted by National Cancer Institute Journal » FDA Grants Epeius Biotechnologies' Rexin-G A Third Orphan Drug Designation, This Time for the Treatment of Soft Tissue Sarcomas » Epeius Biotechnologies' Tumor-Targeted Rexin-G Receives FDA Orphan Drug Designation for The Treatment of Osteosarcoma » Phase I/II Study of Targeted Gene Delivery In Vivo - Intravenous Infusions of REXIN-G

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