Incyte Corporation,, Wilmington, announced that a Phase III trial of ruxolitinib fared well when compared to best available therapy in patients with polycythemia vera, a blood disorder.
“One out of four patients with polycythemia vera remain uncontrolled despite existing standard therapies, and these patients face a profound symptom burden and are at greater risk of cardiovascular complications. These Phase III data give us confidence that ruxolitinib may offer a welcome new treatment option,” said Herve Hoppenot, the new CEO of Incyte.
The global, Phase III trial, called RESPONSE, was conducted at 109 sites and included 222 patients with polycythemia vera resistant to a primary form of treatment.
Results will be presented to the Food and Drug Administration, which will determine whether the drug can go on the market. Ruxolitinib, sold under the name Jakafi, is now used to treat a form of blood cancer that affects an estimates 16,000 to 18,000 US residents.
Incyte will move into a new headquarters and research center at the former Wanamaker building near Wilmington. Polycythemia vera is characterized by an overproduction of normal red blood cells and often occurs in older patients.
Symptoms include fatigue, night sweats, bone pain, fever and weight loss. In patients who experience severe and burdensome symptoms, data show that the disease causes a significant erosion of quality of life, especially in cases where patients have enlarged spleens. About 100,000 persons in the U.S. Are believed to have the disease.
