The USA's Introgen Therapeutics, a developer of targeted molecular therapies for cancer, has reported additional efficacy data from recent regulatory filings seeking approval of Advexin (contusugene ladenovec).
These findings resulted from supportive statistical analyses based on data from the Phase III clinical trial of Advexin in patients with recurrent, refractory head and neck cancer. These evaluated length of survival in patients in the biomarker population receiving Advexin compared to those treated with methotrexate. Results showed that patients with p53 tumor profiles positive for Advexin efficacy demonstrated statistically-significant increased survival benefit (p = 0.0265). These data were presented at the American Association for Cancer Research conference held in Monterey, California.
"These analyses were conducted as part of Introgen's recent regulatory approval application submission process in the USA and Europe and add to the previously reported findings of Advexin efficacy," said Max Talbot, Introgen's senior vice president of commercial development. "We will continue to identify and utilize relevant opportunities to publish and present more detailed findings from our regulatory submissions," he added.
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