Giving Head & Neck Cancer a Cold (INGN)
Introgen Therapeutics Inc. (NASDAQ: INGN) has made a fairly important filing with the FDA this week, yet the importance of the filing has been overlooked. Maybe it’s a shortened work week, maybe it is a bear market, or maybe we are just stretching for key biotech news. It could even be a combination of all three.
All joking aside, Introgen has asked the FDA to give its Biologic License Application (”BLA”) a priority review for its gene-based therapy called Advexin for head and neck cancer.
This apparently culminates in some cases 14 years of research. This may be a major milestone as this appears to be a filing of the first application for a gene-based therapy. The company is already seeking an approval in Europe.
Advexin is supposed to work by using inactivated cold virus cells to deliver the p53 suppressor gene into cancer cells. The data indicates that the drug only or mainly works on people with low levels of the p53 gene. Apparently two thirds of patients with head and neck cancer were able to take the drug in clinical trials.
Delivering gene function into the tumor could be treating a disease at its most basic and fundamental level. Whether or not this is approved and whether or not this works as well as some hope, that is a different issue entirely.
Shares barely traded above average showing yesterday with 287,300 shares trading hands for a gain of less than 2% to $1.55. Today isn’t much better with another 1.9% gain to $1.58 on 237,00 shares (1:30 PM EST). Introgen’s 52-week trading range is $1.47 to $4.85, and its current market cap is $69.5 million.
Jon Ogg
July 1, 2008