Boston, MA 06/04/2014 (wallstreetpr) – Incyte Corporation (NASDAQ:INCY) reported the results for its RESPONSE trail today, the first fundamental Phase III study estimating a JAK1/JAK2 inhibitor in polycythemia vera treatment.
Ruxolitnib was observed to show better results than the best available treatments. It enhanced hematocrit control that is, resulted in an enhanced volume of red blood cells without the patient having to undergo phlebotomy, which requires removing blood from the body in order to decrease the RCS count. The drug was also effective in decreasing the size of spleen in patients with unmanageable PV and those who are intolerant of or resistant to hydroxyurea.
Trail Data
The RESPONSE study showed that 77% patients who received the ruxolitinib treatment successfully achieved at least one key endpoint component. The same was observed on only 20% of BAT patients. The endpoints under measurement were either hematocrit control between the eighth to thirty- second week of therapy and a reduction in spleen size of at least 35%. The percentage of patients who reached the composite key endpoint after this treatment was 21%, while percentage for equivalent BAT treated patients was only 1%.
The data from the trail additionally also demonstrated enhanced symptoms including fatigue and itching, added Srdan Verstovsek, who is an M.D., Ph.D., and a Professor at the Department of Leukemia in the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. He also said that data also showed decreased thrombosis rate.
The detailed data will sustain global regulatory filings which are expected this year and it is also anticipated to be submitted to the U.S. Food and Drug Administration later this month. The Wilmington, Delaware based drug manufacturer is to present the findings of the study at the 50th Annual Meeting of the American Society of Clinical Oncology, which is scheduled to be held in Chicago.
