EXELIXIS FILES IND APPLICATION FOR ANTICANCER COMPOUND

Exelixis has submitted an investigational new drug (IND) application to the FDA to begin trials of XL147, an anticancer compound. XL147 is an orally available small-molecule inhibitor of phosphoinositide-3 kinase (PI3K). Activation of PI3K is a frequent event in human tumors, promoting tumor cell growth, survival and resistance to chemotherapy and radiotherapy, according to the company.

"A growing body of data indicates that inappropriate activation of the PI3K signaling pathway is a common feature of human tumors and may result from dysregulation at multiple points along the signaling cascade," Gisela Schwab, senior vice president and chief medical officer at Exelixis, said. "We are therefore evaluating multiple compounds that inhibit distinct components of the PI3K pathway. With this strategy, we believe that we are well positioned to maximize the potential of inhibiting the PI3K pathway for the treatment of multiple cancers."

In preclinical studies, XL147 slowed tumor growth or caused tumor shrinkage in multiple preclinical cancer models, including breast, lung, ovarian and prostate cancers and gliomas. XL147 has also been shown to enhance the antitumor effects of several chemotherapeutic agents and be an inhibitor of epidermal growth factor receptors.

This is the 12th IND application that Exelixis has filed from its internal discovery and development programs.