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Drugs and Pharmaceuticals News
Epeius Biotechnologies' Rexin-G Receives FDA Fast Track
Designation for the Treatment of Pancreatic Cancer
Edited by Debra Tone
Wed, 17 Jun 2009, 06:00:17 EDT
SAN MARINO, Calif., June 17 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies (www.epeiusbiotech.com) announced
today that its lead product, Rexin-G®, has been granted Fast Track designation by the U.S. Food and Drug Administration
(FDA) for use as a second-line treatment for advanced or metastatic pancreatic cancer. The FDA Fast Track program, like
Priority Review and Accelerated Approval, was implemented to facilitate the development and expedite the review of
potentially important new drugs.
The Fast Track Product designation, in particular, is granted following a critical evaluation of
the "seriousness" or life-threatening nature of the unmet medical need, namely pancreatic
cancer, and the potential of Rexin-G and its progressive clinical development to address
this unmet need.
"This is an excellent affirmation of all that we have worked for," says Dr. Erlinda Maria
Gordon, Medical Director of Epeius Biotechnologies, "and an important validation of our
medical mission." Indeed, Rexin-G is the first in an entirely new class of targeted anti-
cancer agents, with a sophistication that goes well beyond a simplistic antibody. Rexin-G is
the flagship of tumor-targeted genetic medicine: "smart," "stealth," "selective" and "potent"
nano-medicine that not only seeks out and accumulates in cancerous lesions that have
spread throughout the body, but delivers a tumor-killing designer gene where it is needed most, selectively destroying tumor
cells and their attendant blood supply, while sparing normal cells and healthy tissues.
As presented at the 2009 ASCO G.I. Symposium, "Rexin-G Shrinks Metastatic Tumors and Triples Survival Time in
Chemotherapy-Resistant Pancreatic Cancer," documenting survival benefits, without toxicity, as monotherapy, wh