Read Zacks_Analysts' blog in RSS
June 9, 2010
Share This
Keryx Biopharmaceuticals Inc. (KERX) presented encouraging data from a mid-stage study for KRX-0401 (perifosine), which is being developed for treating advanced metastatic colorectal cancer, at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago. KRX-0401 has been in-licensed by Keryx from Canadian drugmaker Aeterna Zentaris Inc. (AEZS) in the US, Canada and Mexico.
The randomized, double-blind, placebo-controlled study compared perifosine plus capecitabine (Xeloda) with placebo plus capecitabine in patients with refractory advanced colorectal cancer. The final results from the study demonstrated statistically significant improvement not only in the time to tumor progression but also in the overall survival in the perifosine and capecitabine arm compared with patients in the placebo and capecitabine group.
The mid-stage study (n=38) was conducted at 11 centers across the US and involved heavily pre-treated patients suffering from second- or third-line metastatic colorectal cancer. They were randomized to receive capecitabine, marketed by Roche (RHHBY) as Xeloda, on days 1–14 every 3 weeks in addition to either perifosine or placebo daily.
Keryx has started a late-stage study of perifosine for the same indication, based on the encouraging mid-stage data, under the US Food and Drug Administration’s (FDA) Special Protocol Assessment (SPA) program. The company is enrolling patients for the study at multiple centers throughout the US.
Apart from colorectal cancer, perifosine is being studied in a phase III trial under an SPA for the treatment of relapsed/refractory multiple myeloma. Furthermore, the candidate is in early-stage development for other forms of cancer.
Despite the presence of many products such as Sanofi-Aventis’ (SNY) Eloxatin (oxaliplatin), Roche’s Avastin (bevacizumab) and Pfizer’s (PFE) Camptosar (irinotecan) in the field of colorectal cancer, the demand still remains 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.
Read the full analyst report on "KERX"
Read the full analyst report on "AEZS"
Read the full analyst report on "PFE"
Read the full analyst report on "RHHBY"
Read the full analyst report on "SNY"
Zacks Investment Research