• Aeolus Pharmaceuticals Inc., of Mission Viejo, Calif., reported preliminary results from a pilot study of AEOL 10150 and G-CSF drug Neupogen (filgrastim, Amgen Inc.), which confirmed that AEOL 10150 does not interfere with the positive effects of Neupogen on the hematopoietic syndrome of acute radiation syndrome. The two products in combination were safe and well tolerated. AEOL 10150 is a broad-spectrum catalytic antioxidant designed to neutralize reactive oxygen and nitrogen species.

• Cytokinetics Inc., of South San Francisco, said it started a second cohort of an ongoing Phase II trial of CK-2017357, a fast skeletal muscle troponin activator, in patients with amyotrophic lateral sclerosis. That cohort, or Part B, is designed to evaluate the safety and tolerability of multiple doses of CK-2017357 in patients who also are receiving riluzole. About 24 patients are expected to be enrolled. Secondary objectives will measure the ALS Functional Rating Scale-revised, other measures of pulmonary function, muscle strength and fatigue and physician and patient global assessments.

• DARA BioSciences Inc., of Raleigh, N.C., reported data from a Phase Ib trial showing that DB959, a peroxisome proliferator activated receptor-delta/gamma agonist, had a safety profile comparable to placebo when given as once-daily doses for seven sequential days and was safe and well tolerated throughout the 40-fold dose range tested. Results of steady-state pharmacokinetic measurements indicated that the compound is highly likely to meet the target dosing regimen of once per day. DB959 is in development for Type II diabetes. Detailed data from the study are anticipated in the first half of 2012.

• Nuron Biotech Inc., of Exton, Pa., said it started a pivotal, Phase III trial of NU100, a recombinant human interferon beta-1b (IFN beta-1b), in patients with relapsing-remitting multiple sclerosis. The study is expected to involve 500 patients randomized to receive NU100, a marketed IFN beta-1b or placebo over a 12-month period. Data are anticipated in late 2013.

• Santarus Inc., of San Diego, said an analysis of pooled data from its two Phase III studies indicated that budesonide MMX 9 mg taken once daily for the induction of remission of mild or moderate active ulcerative colitis was statistically superior to placebo. Pooled data from 672 patients showed clinical and endoscopic remission for budesonide MMX of 17.7 percent vs. 6.2 percent for placebo (p = 0.0002), while symptom resolution was 26.3 percent for the treatment group vs. 14.3 percent for the placebo group (p = 0.0015.) Those and other data were presented at the American College of Gastroenterology meeting in Washington. Santarus also said it selected Uceris as the trade name for budesonide MMX.

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