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March 23, 2014
15:44 EDTCELGCelgene releases new research findings on OTEZLA
Celgene Corporation released new research findings on OTEZLA, apremilast, the company’s oral, selective inhibitor of phosphodiesterase 4, PDE4, from the ESTEEM 1 and 2 phase III studies in patients with moderate to severe plaque psoriasis at the 72nd Annual Meeting of the American Academy of Dermatology, AAD, Annual Meeting in Denver, CO. ESTEEM 1 demonstrated a stable mean PASI improvement of 81 to 88% between weeks 32 and 52 for those patients who were treated for 52 weeks with OTEZLA 30 mg BID and who achieved a PASI-75 score at week 32 . These data are consistent with the mean PASI-75 improvement observed between weeks 16 and 32. In the same group of patients, OTEZLA 30 mg BID continued to demonstrate improvements in difficult-to-treat areas affected by plaque psoriasis...In ESTEEM 2, a significantly higher percentage of patients receiving OTEZLA 30 mg BID achieved a PASI-75 response at week 16, primary endpoint, compared with patients who received placebo. Statistical significance at week 16 was also demonstrated for the major secondary endpoint, static Physician Global Assessment, sPGA, score of clear or almost clear. The beneficial effects of OTEZLA on psoriasis in difficult-to-treat areas of scalp, nails, palms and soles were also demonstrated in ESTEEM 2. After 16 weeks of treatment, OTEZLA 30 mg BID demonstrated significantly higher response rates versus placebo for psoriasis affecting the scalp...“Psoriasis of the nails, scalp and palmoplantar regions is very difficult to treat and can be debilitating for individuals dealing with this chronic disease," said Jennifer Cather, MD, Modern Research Associates, Dallas, Texas. “Results from the 52-week analysis of the ESTEEM program suggest that early responses seen with OTEZLA treatment in multiple efficacy endpoints of plaque psoriasis, including difficult to treat areas, are durable over time. Together with the observed long-term consistent safety and tolerability profile, these findings are encouraging.” A separate analysis of long-term safety and tolerability data from ESTEEM 1 identified no new or unexpected adverse events (AEs) for patients treated with OTEZLA compared with results at week 16...No new or unexpected AEs were identified for patients treated with OTEZLA in ESTEEM 2.
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August 26, 2014
11:20 EDTCELGCelgene added to short term buy list at Deutsche Bank
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09:35 EDTCELGActive equity options trading on open
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August 25, 2014
12:19 EDTCELGOn The Fly: Midday Wrap
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10:40 EDTCELGBiotechs rise after InterMune acquired by Roche
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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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