Introgen presents additional efficacy data for Phase III tumor drug

These findings resulted from supportive statistical analyses based on data from the pivotal Phase III clinical trial of Advexin in patients with recurrent, refractory head and neck cancer. These analyses evaluated the length of survival of patients in the biomarker population receiving Advexin as compared to patients in the biomarker population receiving methotrexate.

Results showed that patients with p53 tumor profiles positive for Advexin efficacy demonstrated statistically significant increased survival benefit at both six months and overall following treatment with Advexin. Additionally, these analyses showed that for patients with tumor p53 profiles negative for Advexin efficacy, there is a statistically significant increased survival benefit associated with methotrexate treatment.

In conjunction with previously reported findings, Introgen believes these latest results extend and confirm that Advexin, as compared to methotrexate, achieved statistically significant benefits in tumor response rate, six-month survival, and overall survival in the study’s prospectively defined p53 biomarker patient population.

Accordingly, Advexin successfully achieved both the study’s primary and secondary efficacy endpoints in the biomarker patient population which were prospectively designated with the FDA. The primary efficacy endpoint of the Phase III study was survival in either the intent-to-treat (ITT) or biomarker patient population. The secondary efficacy endpoint was tumor response in either the ITT or biomarker patient population.

Robert Sobol, senior vice president of medical and scientific affairs at Introgen, said: “We look forward to working with the FDA and European Medicines Evaluation Agency in connection with the approval process of Advexin for patients with recurrent, refractory head and neck cancer.”