Introgen anticipates BLA filing for Advexin in early 2008
This article was originally published in Pharmaceutical Approvals Monthly
Introgen Therapeutics will include additional patient tissue samples from Phase III trials to strengthen regulatory filings in the U.S. and Europe for its targeted oncologic Advexin, based on recommendations from external advisors, firm announces Dec. 20. The additional data will strengthen correlation data between p53 biomarker analyses - abnormalities and protein levels - and tumor response or increased survival following treatment with Advexin. Introgen expects to submit a BLA and marketing authorization application, as well as announce top-line Phase III data, in early 2008. The Phase III trial evaluated Advexin in head and neck cancer patients...
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