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12:00 AM
May 28, 2007
 |  BioCentury  |  Product Development

Antigenics getting the message

Despite reporting positive updated data from a Phase III trial last week, Antigenics Inc. is not optimistic about taking its Oncophage vitespen vaccine to FDA based on post hoc analyses of failed pivotal trials. While it plans to discuss with FDA the feasibility of an Oncophage BLA submission in renal cell carcinoma, the company said that neither it nor its investors are interested in running a prospective confirmatory trial typically required to garner U.S. approval, which probably would take up to a decade in this patient population.

Absent some shorter route for RCC in the U.S., AGEN intends to pursue regulatory submissions in off-shore markets to buy time and funding to move the vaccine forward in the clinic for glioma, an indication in which it could have a greater chance for U.S. approval.

In March 2006, AGEN (New York, N.Y.) reported data from the Phase III C-100-12 trial in renal cell carcinoma (RCC) showing that Oncophage missed the primary endpoint of recurrence-free survival (RFS) because it turned out that it was harder than anticipated to identify patients who met the enrollment criteria of no residual disease or metastases at baseline. It...

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