Incyte Corporation, Wilmington, reported disappointing results in a clinical trial that used ruxolitinib to treat a blood disorder.
Incyte, which is moving its operations to a site near the city developed Jakafi ruxolitinib. It continues to look for treatment options for the drug.
While positive trends were observed, the RELIFE trial did not result in a 50% reduction in symptoms that included tiredness, itching, muscle aches, night sweats and sweats associated with polycythemia vera.
“RELIEF was designed to provide us with additional information regarding symptom improvement and is not required for FDA approval. The patients recruited into the RELIEF study had less advanced PV compared to those in RESPONSE, our larger pivotal Phase III study which formed the basis of the sNDA, and which met the primary endpoint of improved hematocrit control and reduced spleen size in patients with uncontrolled PV,” stated Richard Levy, M.D., executive vice president, chief drug development & medical officer of Incyte.
Further analyses of RELIEF are underway.
Hervé Hoppenot, CEO of Incyte, commented, “One in four patients with PV remain uncontrolled despite best available therapies. Such patients may have severe disease-related symptoms and elevated blood counts which put them at greater risk of cardiovascular complications such as stroke, pulmonary embolism, deep vein thrombosis and heart attack. Based on the positive and statistically significant results from the pivotal Phase III RESPONSE trial, as presented at ASCO last month, we remain confident that ruxolitinib has the potential to become an important new treatment for PV patients who are no longer responding to, or are intolerant of, hydroxyurea.”
Polycythemia vera (PV) is characterized by an overproduction of normal red blood cells, white blood cells and platelets PV may occur at any age but often presents later in life, with a median age at diagnosis of 60 years. Approximately 100,000 patients in the U.S. have the disorder.
