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Celgene Corp. (CELG) Message Board

  • rob_cos rob_cos Sep 24, 2013 3:48 PM Flag

    Barclays "Significant improvements in ACR20 scores were seen across three PALACE trials...safety/efficacy comparable to competition-52 week

    Barclays " ACR abstracts- positive efficacy/safety results over 52 weeks in 3 Phase III trials (PALACE 1, 2, 3) - Significant improvements in ACR20 scores were seen across three PALACE trials..."

    Abstracts from the upcoming American College of Rheumatology (ACR) meeting demonstrate long-term safety and efficacy of apremilast in psoriatic arthritis (PsA): ACR meeting abstracts were released which showed positive efficacy and safety results over 52 weeks in three Phase III trials (PALACE 1, 2, 3) involving patients with active PsA despite prior use of DMARDs and/or biologics.

    Significant improvements in ACR20 scores were seen across three PALACE trials. In the PALACE-3 study, apremilast (20mg BID and 30mg BID) treated patients saw continued improvements in their ACR20 scores, from 25-45% responding in week 16 to 55-60% by week 52. In the PALACE-2 trial, a similar trend was observed, however ACR20 response rates began to stabilize to approximately 50% by week 40. Furthermore, pooled data from all three PALACE studies shows the 30mg BID dose led to significant improvements in the Health Assessment Questionnaire-Disability Index and physical function at week 24 and 52.

    Apremilast proves tolerable even after 1-year of therapy: A total of 1,493 patients were randomized and received either placebo or apremilast (20mg or 30mg) in the three PALACE studies. The most common adverse events (AEs) were mild to moderate in severity, including diarrhea (14.3%), nausea (12.6%) and headache (10.1%). Discontinuations due to AEs were 7.5% in the 20mg group and 8.3% in the 30mg group. Overall, no new safety concerns arose from week 24 to week 52 of treatment on apremilast.

    continued in reply or see Investor Village CELG board board for full report

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    • Very positive. Still nothing yet on Yahoo, perhaps tomorrow morning.

    • Apremilast proves tolerable even after 1-year of therapy: A total of 1,493 patients were randomized and received either placebo or apremilast (20mg or 30mg) in the three PALACE studies. The most common adverse events (AEs) were mild to moderate in severity, including diarrhea (14.3%), nausea (12.6%) and headache (10.1%). Discontinuations due to AEs were 7.5% in the 20mg group and 8.3% in the 30mg group. Overall, no new safety concerns arose from week 24 to week 52 of treatment on apremilast.

      Results from PALACE trials appear competitive to currently approved agents: In a Phase III randomized study, Enbrel demonstrated an ACR20 response rate of 50% (versus 13% for placebo) in patients with active PsA. We believe apremilast can be a competitive therapy in the market place with consistent safety profile, oral formulation, and similar efficacy to the TNF inhibitors such as Enbrel and Humira

 
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