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Threshold
Pharmaceuticals
THLD today announced that the U.S.
Food and Drug Administration (FDA) has reached agreement with the
U.S. affiliate of Merck KGaA, Darmstadt, Germany, Threshold's partner
for the development and commercialization of TH-302, covering a
Special Protocol Assessment (SPA) for a Phase 3 randomized trial of
TH-302 in patients with metastatic or locally advanced unresectable
pancreatic cancer. The trial is designed to evaluate the efficacy and
safety of TH-302 in combination with gemcitabine compared with
gemcitabine therapy alone. Pursuant to Threshold's license and
co-development agreement with Merck, Merck will be responsible for
conducting the Phase 3 study under the SPA.
A Special Protocol Assessment (SPA) is a written agreement with the
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