Introgen presents biomarker data demonstrating abnormal p53 predicts Advexin efficacy in head and neck, lung, prostate and Li-Fraumeni cancers

Co reports the results of new data analysis from multiple Phase 2 clinical studies showing a statistically significant correlation between the abnormal p53 biomarker and tumor response after treatment with Advexin in patients with head and neck, lung, prostate and Li-Fraumeni Syndrome cancers. In 54 late-stage cancer patient samples evaluated from the Company's Phase 2 studies, tumor response after Advexin monotherapy was observed in 35% of patients with the abnormal p53 biomarker and all tumor responses occurred in the abnormal p53 biomarker group (p = 0.0013). The majority of these patients had recurrent disease after receiving standard therapies. INGN has previously reported study results demonstrating a statistically significant correlation between the abnormal p53 biomarker and increased survival after Advexin therapy in head and neck cancer patients. "The results presented today confirm and extend previous biomarker data correlating the abnormal p53 biomarker with increased tumor responses following Advexin treatment and support its use as a biomarker to predict Advexin efficacy," said John Nemunaitis, M.D., a principal investigator of the studies and executive director of the Mary Crowley Medical Research Center. "Importantly, the data from multiple tumor types indicate an absolute correlation of tumor response and abnormal p53 as 100 percent of the responding tumors had the abnormal p53 biomarker."