Introgen's Advexin Found Effective in Phase II Cancer Trial
Posted on: Monday, 14 April 2008, 09:01 CDT
Introgen Therapeutics has reported that Advexin Phase III clinical trial data in patients with recurrent head and neck cancer confirm earlier Phase II results of Advexin efficacy.
The data were generated from a Phase III study that prospectively evaluated patients with biomarkers identified from earlier clinical studies. These results confirm the predictive value of p53 biomarkers hypothesized from previous Phase I and II Advexin clinical trials.
In the Phase III recurrent head and neck cancer trial, 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 squamous cell carcinoma of the head and neck (SCCHN) patients treated with Advexin monotherapy in Phase I, II and III trials showed tumor response in 79% of patients with p53 biomarkers favorable for Advexin efficacy compared to 25% of patients with unfavorable p53 biomarkers for Advexin.
Robert Sobol, senior vice president, medical and scientific affairs, Introgen, said: "Advexin provides therapeutic benefit by restoring p53 tumor suppressor function which is blocked in the majority of head and neck cancers. The strength of these p53 biomarker data provides important insights to help guide the future use of Advexin treatment while advancing the field of personalized cancer care."
Source: Datamonitor
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