www.fdanews.com/articles/124228-keryx-biopharmaceuticals-agrees-to-spa-for-phase-iii-perifosine-trial
Keryx Biopharmaceuticals Agrees to SPA for Phase III Perifosine Trial
February 3, 2010
Keryx Biopharmaceuticals, Inc. announced Wednesday that it has
reached agreement with the U.S. Food and Drug Administration regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial for its PI3K/Akt
pathway inhibitor, KRX-0401 (perifosine), in patients with refractory metastatic colorectal cancer.
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