Almirall SA, of Barcelona, Spain, and Forest Laboratories Inc., of New York, began a Phase III trial of a fixed-dose combination of aclidinium bromide and formoterol fumarate via the Genuair inhaler for chronic obstructive pulmonary disease (COPD). The trial will enroll 3,500 people with COPD who will receive the drug combination for 24 weeks. An additional safety study will run for 52 weeks. The studies will evaluate bronchodilation parameters, symptoms, health status and COPD exacerbations.
Amgen Inc., of Thousand Oaks, Calif., published results from a Phase III trial of Xgeva (denosumab) for bone metastases of prostate cancer in The Lancet. The study enrolled 1,432 men with hormone-refractory, castration-resistant prostate cancer with no bone metastases at baseline. It showed that Xgeva significantly prolonged bone metastasis-free survival by 4.2 months, delayed bone metastasis by 3.7 months and reduced symptoms of bone metastasis by 33 percent.
Bionovo Inc., of Emeryville, Calif., reported that the first patient was randomized and will begin dosing in a Phase III pivotal trial evaluating the safety and efficacy of two doses (5 g/day and 10 g/day) of Menerba (MF101) in 1,200 postmenopausal women for the treatment of menopausal hot flashes. Efficacy will be measured by the reduction of moderate to severe hot flushes from baseline to 12 weeks of treatment.
BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., published additional data from its pharmacokinetic study of LibiGel showing that the drug increases free testosterone in the serum of postmenopausal women to the normal range for premenopausal women. BioSante is developing LibiGel for female sexual dysfunction. The study is published in The Lancet.
GlaxoSmithKline plc, of London, said top-line data from the first of eight Phase III studies of albiglutide, a once-weekly glucagon-like peptide-1 agonist, failed to meet the primary endpoint of noninferiority to Victoza (liraglutide, Novo Nordisk A/S), though it did demonstrate a statistically significant reduction in HbA1c from baseline (p < 0.001). The 32-week, 841-patient study, designated Harmony 7, was designed to test albiglutide against once-daily GLP-1 Victoza in adults with Type II diabetes. The remaining seven studies are ongoing and are testing albiglutide as a monotherapy and as add-on therapy compared to placebo and/or active comparators.
Nile Therapeutics Inc., of San Mateo, Calif., released top-line data from a Phase I trial of cenderitide in chronic heart failure. The drug was given to 12 patients by two subcutaneous bolus injections in part A of the trial, and in part B, 34 patients were given a 24-hour continuous subcutaneous infusion of a weight-based dose of cenderitide or placebo. The trial showed that weight-based doses of cenderitide achieved target PK levels when delivered by subcutaneous pump, and that it was well tolerated, bioavailable and reduced PK variability compared to a fixed-dose regiment.