Pharmaceutical Business review

Exelixis seeks FDA approval to develop cancer compound

XL184 is the seventh drug to reach clinical development from the company’s internal discovery program within two years. Pending FDA clearance, Exelixis intends to initiate a phase I clinical trial of the formulation.

In preclinical studies, XL184 has shown potent inhibition of the hepatocyte growth factor receptor (Met) and vascular endothelial growth factor receptor 2 (VEGFR2 [KDR]) receptor tyrosine kinases (RTKs), proteins, which are believed to play synergistic roles in promoting tumor growth and angiogenesis.

Additionally, XL184 has exhibited potent inhibition of other important RTKs that have been implicated in various forms of cancer including mast/stem cell growth factor (KIT), FMS-like tyrosine kinase 3 (Flt3) and tyrosine-protein kinase receptor (Tie-2). In preclinical efficacy studies, XL184 prevented tumor growth and induced the regression of large tumors in a broad range of human tumor xenograft models including breast cancer, lung cancer and glioma.

The company currently has ongoing phase I clinical trials for a number of other compounds and expects to initiate phase II and III studies by the end of the year.