Wednesday, Æterna Zentaris Inc. (AEZS, AEZ.TO) said that its partner, Keryx Biopharmaceuticals (KERX), signed an agreement with the U.S. Food and Drug Administration regarding a Special Protocol Assessment on the design of a Phase 3 trial for its PI3K/Akt pathway inhibitor, perifosine, in patients with refractory metastatic colorectal cancer.
The SPA provides agreement that the Phase 3 study design adequately addresses objectives in support of a regulatory submission. Keryx is Æterna Zentaris' partner and licensee for perifosine in the United States, Canada and Mexico. Perifosine is also out-licensed to Handok in South Korea while Æterna Zentaris retains rights for the rest of the world.
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