Wednesday, Introgen Therapeutics Inc. (INGN) announced additional efficacy data from the company's recent regulatory filings seeking approval of Advexin in the United States and Europe. The findings stem from supportive statistical analyses on data from the pivotal Phase 3 clinical trial of Advexin in patients with recurrent, refractory head and neck cancer.
The results showed Advexin, a p53 tumor suppressor therapy, with statistically significant and increased overall survival benefit at both six months and overall following treatment.
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.
In conjunction with previously reported findings, Introgen believes that 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, the company said that Advexin achieved both the study's primary and secondary efficacy endpoints in the biomarker patient population which were prospectively designated with the United States Food and Drug Administration.
INGN is currently trading at $1.12, up 8 cents or 7.69%.
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