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Latest New Medical Therapy Results
AM-Pharma issued positive results from a phase II trial of Alkaline Phosphatase for acute kidney injury. This double blind, placebo controlled, study enrolled 36 subjects with acute kidney injury secondary to sepsis. The subjects received Alkaline Phosphatase intravenously for 48 hours and were followed for 28 days. A composite analysis of all primary renal function efficacy parameters, creatinine clearance, serum creatinine and dialysis requirement showed statistically significant improvement compared to placebo (p≡0.005). Renal creatinine clearance improved more than twice as fast in the treated group during the first 7 days, (p<0.02) resulting in normalization of creatinine clearance for the rest of the 28 days, compared to the placebo group, where creatinine clearance remained impaired (p<0.02). There was a reduction of dialysis requirement after treatment with Alkaline Phosphatase compared to placebo (means: 10 hours versus 53 hours, p≡0.08). Secondary endpoints were also reached with significance. Treatment with Alkaline Phosphatase resulted in shorter stay in the intensive care unit (11 days versus 25 days; p<0.02) and in reduced need for mechanical ventilation (3.9 days versus 6.0 days; p<0.03).
Argos released positive results from a phase I/II trial of AGS-003, a personalized, RNA-loaded, dendritic cell-based immunotherapy for metastatic renal cell carcinoma (mRCC). This open label study enrolled 20 newly diagnosed post-nephrectomy patients with clear cell mRCC. The subjects received intradermal injections of AGS-003 in the following sequence: five biweekly doses, four monthly doses, and one dose every three months until disease progression. Primary endpoints of the study included clinical and immune response. At baseline, the majority of evaluable subjects suffered impaired cellular immunity to RCC tumor antigens. Following AGS-003 treatment, the majority of evaluable patients experienced detectable cellular immunity to these same antigens, demonstrating that AGS-003 induced a tumor-specific immune response. In addition, 50% of subjects had restored T cell-mediated interleukin-2 and interferon-3 responses, indicating general immune reconstitution. Secondary endpoints included progression free survival (PFS). The median length of PFS was 5.6 months, in contrast to the historical median PFS for interferon of 5.1 and 2.5 months for intermediate and poor-risk subjects, respectively. Clinical benefit, defined as either a partial response or stable disease, was reached by 41% of the subjects. AGS-003 was well tolerated, with no drug-related serious adverse events.
Bristol Myers Squibb and Pfizer reported positive results from a phase III trial of apixaban for the prevention and treatment of venous thromboembolism. This head-to-head, randomized, double-blind, safety and efficacy study, dubbed ADVANCE-2, enrolled 3,221 subjects undergoing elective knee replacement surgery. The subjects received 2.5 mg of apixaban orally twice daily or subcutaneous enoxaparin 40 mg once daily, over a 10-to-14 day treatment period. The primary efficacy endpoint was the composite of asymptomatic and symptomatic deep vein thrombosis, non-fatal pulmonary embolism, and death from any cause during study treatment. The primary efficacy endpoint occurred in 15.1% of the apixaban group and 24.4% of the enoxaparin group, resulting in a statistically significant relative risk reduction for apixaban of 38% (p<0.0001). The secondary efficacy endpoint, major venous thromboembolism, occurred in 1.1% of the apixaban group compared with 2.2% of the enoxaparin group (one-sided p≡0.02). The incidences of major bleeding and clinically relevant non-major bleeding were similar between the treatment arms. All other safety parameters were comparable.
