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Novartis' myelofibrosis drug shows promise

Novartis has announced that a phase III trial of ruxolitinib has met its primary endpoint of significantly reducing spleen size in patients with myelofibrosis

Novartis has announced that a phase III trial of ruxolitinib (INC424), its investigational Janus kinase (JAK) inhibitor, has met its primary endpoint of significantly reducing spleen size in patients with myelofibrosis (MF), a rare blood cancer.

The trial, which was the second phase III study of INC424, took place in Europe. It showed treatment with INC424 provided a statistically significant reduction in spleen size in patients with primary MF, post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF), when compared with best available therapy, administered at doses and schedules determined by the investigator. The safety profile of INC424 was consistent with previous studies.

A previous phase III trial conducted by collaboration partner, Incyte Corporation, took place in the US, Canada and Australia and compared treatment with INC424 to placebo in patients with MF at 24 weeks. The results were consistent with those of the European study.

Hervé Hoppenot, president, Novartis Oncology said: "INC424 illustrates our mission to turn the promise of innovative, pathway-based compounds into the reality of therapies for patients with unmet medical needs."

Myelofibrosis is a rare blood cancer characterised by bone marrow failure, an enlarged spleen and several debilitating symptoms including pruritus, fatigue, weight loss and shortened survival. There are currently limited treatment options for myelofibrosis.

INC424 has been licensed to Novartis from Incyte for development and potential commercialisation outside the US. Rights for the development and potential commercialisation in the US were retained by Incyte. The therapy has been granted orphan drug status for myelofibrosis by both the US Food and Drug Administration (FDA) and the European Commission (EC).

15th March 2011

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