Keryx Biopharmaceuticals (KERX) received fast track status from the US Food and Drug Administration (FDA) for KRX-0401 (perifosine), which is being studied for treating refractory advanced colorectal cancer. This status is granted to drugs with the potential to treat serious or fatal conditions and qualify for a faster review process.
Keryx plans to initiate a phase III trial of perifosine in the second quarter of 2010 under the FDA’s Special Protocol Assessment (SPA) program. The trial aims at comparing perifosine in combination with capecitabine (Xeloda) versus placebo plus capecitabine in patients with refractory advanced colorectal cancer. The study is expected to be completed in the second half of 2011. Keryx plans to launch the drug by mid 2012.
Although perifosine is the lead candidate at Keryx, it is also developing Zerenex (ferric citrate), which has completed a phase II study for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with final-stage renal disease. The phase III trial is yet to begin under an SPA agreement with the FDA.
Apart from colorectal cancer, perifosine is being studied in a phase III trial under an SPA for the treatment of relapsed/refractory multiple myeloma. Keryx has orphan drug status and fast track designation for this study. Keryx does not have any marketed product at present and is heavily dependent on the successful commercialization of perifosine.
Despite the presence of many products such as Sanofi-Aventis’ (SNY) Eloxatin (oxaliplatin), Roche’s (RHHBY) Avastin (bevacizumab), Merck KGaA’s Erbitux (cetuximab), Pfizer’s (PFE) Camptosar (irinotecan) in the field of colorectal cancer, the demand remains still unmet. According to the American Cancer Society, colorectal cancer is the third most common form of cancer diagnosed in the US with over 49,000 casualties in 2009.