Introgen Reports Updated Phase 2 ADVEXIN® Data Correlating Improved Survival, Tumor Responses and Predictive p53 Biomarker
6/5/2007 Chicago, IL press release BusinessWire (home.businesswire.com) Abnormal p53 Predicts Increased Tumor Responses and Survival Introgen Therapeutics, Inc. and the Company’s clinical collaborators today reported updated Phase 2 data demonstrating a significant correlation between abnormal p53, tumor responses and increased survival following ADVEXIN® therapy in patients with recurrent squamous cell carcinoma of the head and neck. The data (Abstract #6057) were presented today at the annual meeting of the American Society of Clinical Oncology in Chicago. Tumor responses were assessed in 112 patients with recurrent head and neck cancer who received ADVEXIN. Overall, the percentages of patients with tumor responses defined by reductions in bi-dimensional tumor area on CT scan of 50 percent, 25 percent, 10 percent or stable disease for more than 2 treatment cycles were 6 percent, 7 percent, 12 percent and 22 percent, respectively. Median survival for these responder populations were 41, 17, 15 and 10 months, respectively. There was a statistically significant increase in median survival for each of the responder populations compared to the 6 month median survival of the non-responders (p < 0.0016). “The 41 month median duration of survival for the patients with a 50 percent or greater reduction in tumor size is very impressive and significantly greater than the six month median survival of non-responders that is typical for patients with recurrent tumors,” said John Nemunaitis, M.D., Medical Director, Mary Crowley Medical Research Center. “Our findings are also consistent with a growing body of data that even smaller reductions in tumor size [...]