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Aeterna Zentaris Inc.
AEZS
today announced that it has reached an agreement
with the U.S. Food and Drug Administration ("FDA") on a Special Protocol
Assessment ("SPA") for an upcoming Phase 3 registration trial in endometrial
cancer with its doxorubicin peptide conjugate, AEZS-108. The SPA agreement
states that the proposed trial protocol design, clinical endpoints and planned
analyses are acceptable to the FDA to support a regulatory submission.
Study Design
This will be an open-label, randomized, multicenter Phase 3 trial conducted in
North America and Europe, comparing AEZS-108 with doxorubicin as second line
therapy for locally-advanced, recurrent or metastatic endometrial cancer. The
trial will involve approximately 500 patients and the primary efficacy
endpoint is improvement in median Overall Survival.
About Special Protocol Assessments ("SPA")
The SPA process is a procedure by which the FDA provides official evaluation
and written guidance on the design and size of proposed protocols that are
intended to form the basis for a Biologics License Application ("BLA") or New
Drug Application ("NDA"). Final marketing approval depends on the results of
efficacy, the adverse event profile and an evaluation of the benefit/risk of
treatment demonstrated in the Phase 3 trial.
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