Introgen provided an update of data from several studies of the drug, including its effect on tumors and also on which patient populations were most likely to benefit from Advexin.
The patients most likely to benefit from Advexin were determined by biological markers. Biomarkers are tests or measurements that can predict response to treatments targeted for particular individuals. Application of these biomarkers can predict the patients who are most likely to respond to Advexin treatment and those patients most likely to be unresponsive to conventional treatments.
The study determined that patients with abnormally high p53 protein expression levels are most likely to benefit from Advexin therapy, but have poor prognoses with conventional therapies.
Data showed that Advexin shrunk tumors in 26.5% of patients with high p53.
The company is now amending its phase III clinical trial analyses plan to include analysis of these biomarkers.