US biotechnology company Exelixis has filed an investigational new drug application with the FDA for its novel anticancer compound.
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Exelixis said that in preclinical studies the compound, XL019, had shown to be a potent, selective and orally available small molecule inhibitor of the cytoplasmic tyrosine kinase JAK2.
Mutations of the JAK2 enzyme are present in some cancers and are frequently observed in patients with myeloproliferative disorders such as myelofibrosis, polycythemia vera and essential thrombocythemia, the company said.
Gisela Schwab, senior vice president and chief medical officer at Exelixis, said: “XL019 is a potent inhibitor of the JAK/STAT signaling pathway, which plays a critical role in cell growth and survival in a number of diseases where few clinical options currently exist.”
Ms Schwab continued: “We believe that evaluation of XL019 in such indications may allow us to early on in clinical development observe biologic activity and potentially affect clinical outcome.”
This is Exelixis’ fourth IND application so far in 2007, and the company now has 14 compounds in clinical development.