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Medical Technology and Biotech News
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Edited by Christopher Simmons, senior news editor
EPEIUS BIOTECHNOLOGIES CORPORATION GAINS FDA ORPHAN DRUG APPROVAL FOR
REXIN-G, THE WORLD'S FIRST TARGETED INJECTABLE GENE THERAPY VECTOR, FOR
PANCREATIC CANCER
LOS ANGELES, Calif. - Sept. 8, 2003 (Send2Press Newswire) -- 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.
Company Website:
www.epeiusbiotech.com
Source of News:
Epeius Biotechnologies Corporation
California Business Newswire
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Medical Technology Newswire
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