Epeius Biotechnologies: FDA orphan drug approval for world's first targeted injectable gene therapy vector for pancreatic cancer

10-Sep-2003
Epeius Biotechnologies Corporation 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."

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Topic world Gene therapy

Genetic diseases once considered untreatable are now at the center of innovative therapeutic approaches. Research and development of gene therapies in biotech and pharma aim to directly correct or replace defective or missing genes to combat disease at the molecular level. This revolutionary approach promises not only to treat symptoms, but to eliminate the cause of the disease itself.

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Topic world Gene therapy

Genetic diseases once considered untreatable are now at the center of innovative therapeutic approaches. Research and development of gene therapies in biotech and pharma aim to directly correct or replace defective or missing genes to combat disease at the molecular level. This revolutionary approach promises not only to treat symptoms, but to eliminate the cause of the disease itself.