WILMINGTON, Del. (AP) – Incyte Corp. said its primary drug candidate succeeded in a late-stage clinical trial that tested the drug as a treatment for myelofibrosis, a cancer of the blood.
The company said 42 percent of patients treated with INCB18424 experienced a significant reduction in swelling of the spleen, which is a common symptom of myelofibrosis. Among patients treated with a placebo, less than 1 percent had a similar reduction. Incyte said this study was the only late-stage trial it is being required to conduct to support approval in the U.S.
Incyte said 309 patients were enrolled in the study, and results were taken 24 weeks after treatment. The most common side effects of treatment with INCB18424 were anemia and thrombocytopenia, or a lack of blood platelets. It said the thrombocytopenia was reversible.
Shares of Incyte picked up 16 cents to close at $15.18 Monday before the test results were issued. The stock rose 67 cents, or 4.4 percent, to $15.85 in aftermarket trading.
The company said there are no approved treatments for myelofibrosis. INCB18424 has received orphan drug status in the U.S. and the European Union. Orphan drug status is given to drugs that could treat rare conditions, and it includes incentives such as extended market exclusivity following approval, assistance in clinical trial design, reduced fees, and tax credits.
Incyte is developing INCB18424 through a partnership with Novartis AG, which is conducting a second late-stage trial in Europe. The company said results from that study are due in early 2011. In addition to myelofibrosis, the drug is being tested as a treatment for the blood disorders polycythemia vera and essential thrombocythemia. It is also being studied against solid tumors and psoriasis.
Date: December 20, 2010
Source: Associated Press