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First gene therapy product to gain FDA orphan drug designation for pancreatic cancer

  September, 14 2003 15:04
your information resource in human molecular genetics
LOS ANGELES, California, August 22, 2003 - Epeius Biotechnologies Corporation ("Epeius" www.epeiusbiotech.com) today announced that the FDA has approved REXIN-G, the world's first tumor-targeted injectable gene therapy vector, as an orphan drug for pancreatic cancer. The FDA's decision to approve REXIN-G was based on objective demonstrations of medical plausibility of REXIN-G as an effective treatment for pancreatic cancer. The major benefit to the company is market exclusivity for the REXIN-G product for all types of pancreatic cancer. This represents a highly significant milestone for Epeius Biotechnologies since its lead product, REXIN-G, is the first gene therapy product to gain FDA orphan drug designation for pancreatic cancer.

Epeius also announced that the Company has executed a screening agreement with the National Cancer Institute wherein NCI scientists will evaluate the activity of REXIN-G and other promising targeted gene therapy products at the NCI. In an interview with Dr. Frederick L. Hall, President and CEO of Epeius Biotechnologies, Dr. Hall emphasized that "Federal and State support is vital to an emerging biotech company like Epeius, to expedite the advancement of REXIN-G and other targeted genetic medicines to the clinic for the benefit of cancer patients. The screening agreement is an important first step.

ABOUT EPEIUS: The mission of Epeius Biotechnologies is to develop and commercialize the first truly effective Targeted Delivery System (TDS) that can be injected directly into a vein to deliver genes and molecular therapeutics preferentially to cancerous tumors that have spread throughout the body (metastatic cancer), without eliciting systemic side effects or organ damage. REXIN-G is the first targeted injectable gene therapy vector that has been approved by both the U.S. FDA and the Philippine BFAD (FDA counterpart) for use in Phase I/II cancer clinical trials. The encouraging results of the first human experience using REXIN-G as intravenous infusions for advanced pancreatic cancer will be presented at the SRI Nucleic Acid World Summit meeting in Boston on September 16, 2003 by Dr. Erlinda M. Gordon, Medical Director of Epeius.

Message posted by: Frank S. Zollmann

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