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Latest New Medical Therapy Trial Results
Following are the most recent results for new drug therapies currently in clinical trials worldwide. Results
are also searchable by therapeutic area beginning with the most recent updates.
Week of May 20, 2013
Creabilis released results from a phase IIb trial of CT327 for the treatment of chronic pruritus in psoriasis. This randomized, double-blind, placebo-controlled study enrolled 160 patients with chronic pruritus in psoriasis. Subjects received CT327 ointment at 0.05%, 0.1% and 0.5% administered twice daily for eight weeks. Data demonstrated patients receiving CT327 showed a statistically significant and clinically meaningful reduction in pruritus compared to blinded placebo vehicle. Pruritus was measured using a visual analogue scale (VAS), the accepted regulatory endpoint. The reduction from baseline in pruritus VAS reached 60% for CT327 compared to 20% for vehicle alone (p<0.05). A clinically meaningful reduction in pruritus (VAS=20mm) was seen in up to 79% of patients for CT327 compared to 36% for vehicle alone (p<0.05). At baseline, 69% of patients reported at least moderate pruritus (VAS>40mm). An improvement was also seen in the CT327 treated groups versus vehicle in mPASI (modified Psoriasis Area and Severity Index) in all subjects. The drug was safe and well tolerated. Subjects receiving CT327 reported fewer adverse events and withdrawals due to pruritus than the vehicle treated patients.
Idera Pharmaceuticals reported results from a phase II trial of IMO-3100 for the treatment of plaque psoriasis. This randomized, double-blind, placebo-controlled study enrolled 44 patients with moderate to severe plaque psoriasis. Subjects received 0.16mg/kg or 0.32mg/kg or IMO-3100, or placebo, by subcutaneous injection once weekly for four weeks, with a follow-up period through day 57. Results showed on day 57, 48% of patients treated with either dose of IMO-3100 demonstrated statistically significant improvements of 35% to 90% from baseline Psoriasis Area Severity Index (PASI) scores compared with 0 in the placebo cohort (p<0.005). Additionally, analysis of biopsy samples collected from patients during the trial indicated PASI score improvements were associated with significant improvement of psoriasis disease-associated gene profile, including down regulation of activated genes in the IL-17 pathway,which is central to the pathogenesis of psoriasis. IMO-3100 was well tolerated at both dose levels. Based on these data, Idera Pharmaceuticals is planning a 12-week phase II trial of IMO-8400 in psoriasis to initiate in the second half of 2013.
Syndax Pharmaceuticals published results from a phase II trial of entinostat for the treatment of estrogen receptor-positive (ER+) breast cancer in the Journal of Clinical Oncology. This randomized, double-blind, placebo-controlled study, ENCORE 301, enrolled 130 postmenopausal women with ER+ breast cancer whose cancer had progressed after treatment with a nonsteroidal aromatase inhibitor. Subjects received 25mg exemestane daily plus 5mg entinostat once per week, or 25mg exemestane plus placebo. Based on intent-to-treat analysis, patients treated with entinostat saw improved median progression-free survival to 4.3 months versus 2.3 months in patients treated with placebo (hazard ratio 0.73; 95% confidence interval, 0.50 to 1.07; one-sided p=.055; two-sided p=.11). Overall survival was an exploratory endpoint, and median survival improved to 28.1 months in entinostat-treated patients versus 19.8 months in placebo-treated (hazard ratio 0.59; 95% confidence interval, 0.36 to 0.97; p=.036). Entinostat was well tolerated. The most frequent adverse events were fatigue and neutropenia. Based on this data, Syndax Pharmaceuticals is working to move entinostat into a confirmatory pivotal study this fall.