Ph III efficacy for Introgen's Advexin

USA-based Introgen Therapeutics says that Advexin (contusugene ladenovec) Phase III clinical trial data in patients with recurrent head and neck cancer confirm earlier Phase II results of efficacy. Biomarkers of the p53 tumor suppressor gene target of Advexin were predictive in selecting patients more likely to respond to the targeted tumor suppressor therapy, which is being investigated for a number of solid tumor cancers.

In the Phase III trial data, which were presented at the American Association for Cancer Research annual meeting, held in San Diego, tumor response was correlated with a statistically-significant increased survival. Importantly, p53 profiles favorable for Advexin efficacy demonstrated a highly statistically-significant correlation between Advexin efficacy and tumor response. An analysis from recurrent head and neck cancer squamous cell carcinoma patients treated with Advexin monotherapy in trials showed tumor response in 79% of patients with p53 biomarkers favorable for Advexin efficacy compared to 25% with unfavorable p53 biomarkers for Advexin (p=0.004 by Fisher's Exact Test).

A comprehensive analysis of Introgen's Phase III data and additional pivotal studies of Advexin in recurrent head and neck cancer, including prospective biomarker analyses demonstrating statistically-significant correlations between p53 biomarkers and increased response and survival following therapy, will be presented at medical conferences later this year, and will be the basis for regulatory submissions in the USA and Europe, the firm noted.