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07-04-2010: Æterna Zentaris Inc. announced that its partner, Keryx Biopharmaceuticals, was granted Fast Track designation by the U.S. Food and Drug Administration for perifosine (KRX-0401), the Company's potentially first-in-class, oral anti-cancer agent that inhibits the phosphoinositide 3-kinase (PI3K)/Akt pathway, for the treatment of refractory advanced colorectal cancer. Keryx is Æterna Zentaris' partner and licensee for perifosine in the United States, Canada and Mexico. Æterna Zentaris has also out-licensed perifosine to Handok in South Korea while retaining rights for the rest of the world.
A randomized, double-blind Phase 3 trial investigating perifosine in combination with capecitabine (Xeloda(R)) versus placebo in combination with capecitabine (Xeloda(R)) in patients with refractory metastatic colorectal cancer is expected to commence this quarter under a Special Protocol Assessment (SPA) with the FDA.
Juergen Engel, Ph.D., President and Chief Executive Officer of Æterna Zentaris, commented, "We now look forward to the initiation and sponsorship by our partner, Keryx, of this key registration Phase 3 trial in refractory metastatic colorectal cancer in North America which they expect to complete in 2011, with product launch, in the USA, in 2012. These data will be very supportive of our efforts to register perifosine in the rest of the world, and in some countries, we expect they will be sufficient to do so without any additional studies."
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Aeterna Zentaris Inc. announced that it has received positive Scientific Advice from the European Medicines Agency (EMA) regarding the Phase 3 trial initiated last April for the development of its lead anticancer proprietary compound, perifosine, in refractory advanced colorectal cancer. Th ... more
Aeterna Zentaris Inc. reported final results on the clinical activity of perifosine (KRX-0401), the Company's novel, potentially first-in-class, oral anticancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, in combination with capecitabine (Xeloda(R)) a ... more
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U. S. Food and Drug Administration (FDA)
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