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Incyte achieves main goal of European phase 3 study for myelofibrosis drug

Published: 12:33 15 Mar 2011 EDT

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Incyte Corp (NASDAQ:INCY) said Tuesday that it has acheived the main goal of its European phase 3 trial for ruxolitinib, a drug to treat myelofibrosis, which is a rare type of blood cancer.

The second phase 3 trial, called Comfort-II, "significantly" reduced the spleen size in patients with the disease when compared to the best available therapy, the Delaware-based company said. Myelofibrosis occurs when the bone marrow is replaced by scar tissue, causing enlargement of the spleen.

The primary goal of the study was to reduce the size of the spleen by 35% or more from baseline to week 48, as measured by an MRI scan.

"The positive results...confirm the data from the US trials and further strengthen our confidence that ruxolitinib has the potential to provide myelofibrosis patients...a new approach to effectively manage this debilitating, life-threatening disease," said president and CEO of Incyte, Paul Friedman.

The safety profile was also consistent with previous studies, Incyte said.

The 219-patient Comfort-II trial was conducted by Novartis, as part of a license agreement between itself and Incyte. Global regulatory filings for the drug, based on data from the two Comfort trials, will begin in the US in the second quarter.

Both the FDA and the European Commission have granted ruxolitinib orphan drug status for myelofibrosis.  Additional clinical studies to test the therapy for its potential use in lymphoma and pancreatic cancer are planned for 2011.

Incyte rallied more than 1.5% on Tuesday to trade at $13.57 as of 12:32pm EST.

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