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Latest New Medical Therapy Results
Agennix reported positive long-term results from a phase II trial of oral talactoferrin alfa for the treatment of severe sepsis. This randomized, double-blind, placebo-controlled study enrolled 190 adult subjects with sepsis, and at least one organ dysfunction due to sepsis, in the US. The subjects received standard therapy and either talactoferrin alfa (1.5 g) or placebo three times a day for up to 28 days or until discharge from the intensive care unit, whichever occurred first. The primary endpoint, a reduction in 28-day all-cause mortality, was achieved. These data show that talactoferrin alfa also reduced all-cause mortality compared to placebo at three and six months. At three months, all-cause mortality was 29.3% in the placebo arm compared to 18.1% in the talactoferrin alfa arm (p%equiv;0.07). At six months, all-cause mortality was 35.2% in the placebo arm compared to 21.3% in the talactoferrin alfa arm (p≡0.04). The absolute reduction in six-month all-cause mortality of 14% was greater than the absolute reduction seen in 28-day all-cause mortality (which was 12%, from 26.6% in the placebo arm to 14.6% in the talactoferrin alfa arm).
Dendreon released positive long-term results from a phase III trial of Provenge, an immunotherapy for the treatment of prostate cancer. This multi-center, randomized, double-blind, placebo-controlled study, dubbed IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment), enrolled 512 subjects with asymptomatic or minimally symptomatic, metastatic, castrate-resistant prostate cancer. According to long term follow-up data (36.5 months and 349 deaths), Provenge increased three-year survival by 40% compared to placebo (32.1% versus 23%). The median survival difference of Provenge compared to placebo was maintained at 4.1 months, with a 24.1% reduction in the risk of death (p≡0.017).
Merck issued positive results from a phase III trial evaluating their sublingual grass allergy immunotherapy tablet. This North-American, randomized, placebo-controlled trial enrolled 345 subjects, ages 5-17 years old, with allergic rhinoconjunctivitis caused by pollen from Timothy grass. The subjects received daily treatment with the grass immunotherapy tablet (15mcg of Phl p5, which is a formulation of the timothy grass allergen) or placebo, at least eight weeks prior to and throughout the 2009 grass pollen season. The primary efficacy endpoint was the total combined score, comprised of total daily symptom score and total daily medication score. The allergy immunotherapy tablet showed a 26% greater improvement in the total combined score (daily symptom score and daily medication score), compared to placebo (p≡0.001). Treatment was generally well tolerated and there were no unexpected adverse events.
Sanofi-aventis issued positive results from a phase III trial of cabazitaxel for the treatment of prostate cancer. This global trial, TROPIC, enrolled 755 subjects with metastatic hormone-refractory prostate cancer whose disease had progressed despite previous docetaxel-based chemotherapy. The subjects were randomized to receive cabazitaxel plus prednisone/prednisolone or mitoxantrone plus prednisone/prednisolone for up to a maximum of 10 cycles. The primary endpoint was overall survival. Results showed that the combination of cabazitaxel and prednisone/prednisolone significantly reduced the risk of death by 30% (p<0.0001) with a clinically meaningful improvement in the median overall survival of 15.1 months in the cabazitaxel combination arm versus 12.7 months in the mitoxantrone combination arm. The secondary endpoint of progression-free survival was also reached. The combination treatment with cabazitaxel resulted in a significant increase in median progression-free survival compared to mitoxantrone (2.8 months versus 1.4 months; p<0.0001).
