Introgen files first gene therapy for FDA approval

Introgen Submits ADVEXIN(R) Regulatory Applications in the U.S. and Europe

I find this development interesting in two respects - as a first gene therapy seeking FDA approval and secondly, as another milestone in the personalized medicine since the treatment is tailored only for patients with low levels of p53.
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After 14 years of research, Introgen Therapeutics is asking the FDA to give its BLA for a gene-based therapy for head and neck cancer--Advexin--a priority review. Experts in the field told the Austin American-Statesman that Introgen had reached a major milestone by filing the first application for a gene-based therapy. The company is already seeking an approval in Europe.

Advexin works by using an inactivated cold virus to deliver the p53 suppressor gene into cancer cells. And the data indicates that the drug only works on people with low levels of the p53 gene. Nevertheless, two thirds of patients with head and neck cancer were able to take the drug in clinical trials.

"When you are able to provide and deliver into the tumor the correct gene function that is missing or defective," said Introgen SVP Robert Sobol, "that is treating a disease at its most basic and fundamental level."

http://www.fiercebiotech.com/press-releases/introgen-submits-advexin-r-regulatory-applications-u-s-and-europe
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