• Alexza Pharmaceuticals Inc., of Mountain View, Calif., has completed enrollment of its second Phase III trial of AZ-004 (Staccato, loxapine), an inhalation product being developed for the treatment of acute agitation in patients with schizophrenia or bipolar disorder. In September, Alexza announced positive results from the first of two planned AZ-004 Phase III studies showing that both the 5-mg and 10-mg doses met the primary endpoint of statistically significant reduction in agitation from baseline to the two-hour postdose time point, compared with placebo. The second AZ-004 Phase III trial is similar in design and scope.

• Cougar Biotechnology Inc., of Los Angeles, announced positive results from an ongoing Phase II trial of investigational drug CB7630 (abiraterone acetate) in prostate cancer. Of the 41 evaluable patients, 21 patients (51 percent) experienced a confirmed decline in prostate-specific antigen (PSA) levels of greater than 50 percent with a median duration of six-plus months. In addition, five patients (12 percent) experienced PSA declines of greater than 90 percent, and 24 (59 percent) experienced an improvement in performance status. Of the 16 evaluable patients with bone metastases, after six months of treatment, four patients (25 percent) showed an improvement in their bone scan and 11 patients (69 percent) showed a stable bone scan. Also, five of five patients with lymph node metastases showed stable disease after six months of treatment and one of two patients with liver metastases demonstrated a partial radiological response (as measured by the RECIST criteria).

• Crucell NV, of Leiden, the Netherlands, and the Aeras Global TB Vaccine Foundation have started a Phase I trial in Kenya of the jointly developed tuberculosis vaccine candidate AERAS-402/Crucell Ad35. The main parameters of the study will be to test the safety of the candidate in healthy adults, all of whom have been vaccinated previously with the Bacille Calmette-Guerin vaccine and a subset of whom have evidence of having been exposed to TB. They also have started a Phase II study of AERAS-402/Crucell Ad35 in Cape Town, South Africa,. Screening of volunteers has begun, and immunization is scheduled to start soon. The candidate will be tested in 82 adults who have had active TB.

• Novo Nordisk Inc., of Princeton, N.J., said a Phase IIIb study (LEAD 6) comparing investigational drug liraglutide to exenatide showed that liraglutide, a human GLP-1 analogue, was significantly more effective at improving blood glucose control (as measured by HbA1c) than exenatide, a GLP-1 mimetic. Fasting plasma glucose also was reduced significantly more with liraglutide, and liraglutide was associated with higher HOMA-B values, an assessment of beta-cell function. The 26-week study included 464 people with Type II diabetes who were randomized to treatment with either liraglutide 1.8 mg once daily or exenatide 10 mcg twice daily, both as an add-on to their existing treatment consisting of metformin and/or a sulphonylurea. Nausea was the most common side effect for both treatments and was reported at a level of 25.5 percent in the liraglutide group and 28 percent in exenatide group (percent of all study participants reporting nausea at least once). However, in the liraglutide group, the percentage of patients reporting nausea in each week fell to 8 percent after five weeks, 4 percent after 10 weeks and 3 percent after 26 weeks. In the exenatide group, reports of nausea fell to 13 percent after eight to 10 weeks of treatment and remained above 10 percent for more than 20 weeks. Data were presented at the Canadian Diabetes Association Congress in Montreal.