Last week, Keryx Biopharmaceuticals, Inc. (KERX) announced that its renal cancer drug KRX-0401 (perifosine) met both primary and secondary endpoints in a mid-stage trial. KRX-0401 is in-licensed by Keryx from Aeterna Zentaris Inc. (AEZS) in the US, Canada and Mexico. The data was presented at the eighth International Kidney Cancer Symposium in Chicago.

The candidate demonstrated efficacy, safety and tolerability in metastatic renal cell carcinoma (RCC) patients whose disease progressed after failing treatment with both a VEGF (vascular endothelial growth factor) receptor inhibitor and an mTOR (mammalian target of rapamycin) inhibitor. Even though the drug was well-tolerated, the most common adverse events were gastrointestinal discomfort and fatigue.

RCC is the most common of all kidney tumors, accounting for 85% of the cases. The advanced form of the disease is resistant to standard therapies such as radiation and chemotherapy.

The initial treatment in most cases is removal of the kidney by surgery. The five-year survival rate is 60% to 70% in the event of cancer being confined to the kidney. However, the survival rate drops significantly otherwise.

Although several biological therapies for the treatment of advanced metastatic RCC have been approved, the incidence of RCC continues to be on the rise according to the National Cancer Institute. The incidence and mortality rates are more than twice as high in men as in women.

Recently, KRX-0401 was granted orphan-drug status by the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma.

We believe that these positive results provide a significant boost to its pipeline as Keryx aims to develop and commercialize pharmaceutical products for the treatment of life-threatening diseases, including renal disease and cancer.

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