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news.Keryx Biopharmaceuticals has received FDA fast track designation for KRX-0401 (perifosine), the company's novel, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, for the treatment of refractory advanced colorectal cancer.
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KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris, in the US, Canada and Mexico.
A randomised, double-blind Phase 3 trial investigating Perifosine in combination with capecitabine (Xeloda) versus placebo in combination with capecitabine in patients with refractory advanced colorectal cancer is expected to commence in the second quarter of 2010 under a special protocol assessment (SPA) with the FDA.
In addition to colorectal cancer, Perifosine is currently in a Phase 3 trial, under SPA, for the treatment of relapsed/refractory multiple myeloma, with orphan drug status and fast track designation granted.
Ron Bentsur, CEO at Keryx Biopharmaceuticals, said: “We believe that this Fast Track designation adds substantial value to Perifosine’s development in refractory advanced colorectal cancer. We intend to initiate the Phase 3 colorectal study in the second quarter, with study completion expected in the second half of 2011.
“With the SPA and Fast Track designation in place, we believe that commercialisation of Perifosine in this indication could potentially commence by mid-2012.”