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hey many drugs moving up fast here Incyte Corporation (Nasdaq:INCY) today reported first quarter 2009 financial results and provided an update on its highest priority clinical programs.
“We continued to make good progress in our lead clinical programs during the first quarter. Thus, over the next few months we expect a number of key events, including the initiation of Phase III trials for INCB18424 in patients with myelofibrosis, the report of final results from the Phase IIb trial for topical INCB18424 in psoriasis, the start of a 6-month multiple-dose trial for INCB28050 in rheumatoid arthritis and the report of final results from our Phase IIb trial for INCB13739 in type 2 diabetes,” stated Paul A. Friedman, M.D., Incyte’s President and Chief Executive Officer. Below is a summary of recent developments for our most advanced product candidates: Janus Kinase (JAK) Inhibitor Program INCB18424: (oral formulation) Myelofibrosis (MF), Polycythemia Vera (PV) and Essential Thrombocythemia (ET) Resubmitted the Special Protocol Assessment to the U.S. Food and Drug Administration (FDA) for treatment in MF. If the FDA agrees with our response we intend to begin our Phase III trials in the second quarter of the year. Submitted the Phase III clinical trial application to Ethics Committees and Competent Health Authorities in Europe. This trial is also expected to begin in the second quarter of the year. Recruitment of approximately 70 clinical sites in the U.S. and Canada, and an equal number in Europe, for the two Phase III registration trials. INCB18424: (topical formulation) Psoriasis and Other Inflammatory Conditions of the Skin Completed enrollment of a three-month multiple-dose Phase IIb trial in patients with mild to moderate psoriasis. Results from this trial are expected in the summer of 2009. INCB28050: JAK Inhibitor Compound for Rheumatoid Arthritis and Other Inflammatory Conditions Completed the required preclinical and clinical trials to support initiation of a double-blind placebo-controlled dose-ranging Phase II program in approximately 100 rheumatoid arthritis patients. This six-month Phase II trial is expected to include clinical sites in the U.S. and Europe and is scheduled to begin enrolling patients in the second quarter of the year. 11beta-HSD1 Inhibitor Program INCB13739: Type 2 Diabetes Completed enrollment of a 3-month placebo-controlled, dose-ranging Phase IIb clinical trial in patients with type 2 diabetes to evaluate the safety and efficacy of once-daily INCB13739 when added to failing metformin monotherapy. Final results from this trial are expected in June 2009 and, if positive, our objective is to secure a partner for this program. Sheddase Inhibitor Program INCB7839: Breast Cancer Continued enrollment of a Phase II trial in combination with Herceptin(R) in breast cancer patients with final results expected in the second half of 2009. Sentiment : Buy Rating :
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