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July 9, 2014
07:04 EDTCELGCelgene says OTEZLA did not achieve primary endpoint in Phase III trial
Celgene Corporation announced results of its phase III POSTURE study evaluating OTEZLA, the company’s oral, selective inhibitor of phosphodiesterase 4, in patients with active ankylosing spondylitis. The OTEZLA arms did not achieve statistically significant improvement versus the placebo arm for the primary endpoint, the percentage of patients who achieve an ASAS 20 response at week 16. However, in a prespecified analysis, meaningful efficacy was observed at Week 24 in a large subset of patients with early-stage disease. Evaluation of the efficacy results is ongoing. An independent data monitoring committee recommended that the study proceed unchanged, based on an assessment of the safety and efficacy data at week 24. According to the protocol, magnetic resonance imaging data will be collected in a subgroup of subjects at week 52 and at additional time points, and radiographs will be taken on all study patients at week 104 and at additional time points. The safety and tolerability data observed in the POSTURE study are consistent with previously reported phase II data in ankylosing spondylitis, as well as six phase III studies of OTEZLA in psoriatic arthritis or psoriasis. No new safety signals were observed. The evaluation of safety and efficacy in the treatment arms is ongoing and the results of the study will be presented at an upcoming medical meeting. These results are from an investigational phase III study. OTEZLA is not approved for the treatment of patients with ankylosing spondylitis in any country.
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August 20, 2014
08:02 EDTCELGBristol-Myers, Celgene enter collaboration agreement for OPDIVO, ABRAXANE
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August 19, 2014
09:38 EDTCELGActive equity options trading on open
Active equity options trading on open according to Track Data: AAPL GILD TSLA CELG VLO VZ FB HD
07:33 EDTCELGCelgene announces publication of REVLIMID combination results
Celgene announced that results of a study evaluating the combination of REVLIMID with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate and prednisone in untreated diffuse large b-cell lymphoma were published online ahead of print in the Journal of Clinical Oncology. In a phase II, open label, single arm study, 64 patients with newly diagnosed, untreated, stage II-IV CD20 positive DLBCL received 25 mg of lenalidomide on days 1-10 with standard dose R-CHOP every 21 days for six cycles. All patients received pegfilgrastim on day two of each cycle and aspirin prophylaxis throughout. The primary endpoint was event-free survival with secondary endpoints of progression free survival and overall survival. A one-stage binomial design was used to assess the efficacy and tolerability of REVLIMID with R-CHOP. Of the 64 patients enrolled, 60 were eligible for response evaluation. In these patients, the overall response rate was 98% with 80% achieving a complete response. The 24-month EFS, which was identical to PFS, and OS rates were 59% and 78%, respectively. The company said, "This study demonstrated that the addition of lenalidomide to conventional R-CHOP resulted in similar PFS rates and OS rates between sub-types. This is intriguing as patients with the non-GCB phenotype have traditionally experienced poorer outcomes. The results of this study support further evaluation of this regimen in this sub-type of DLBCL.”

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