• Aastrom Biosciences Inc., of Ann Arbor, Mich., said results from a Phase I/II clinical trial designed to collect safety and efficacy data utilizing bone repair cells for treating severe non-union fractures found that patients with non-union tibia, humerus or femur fractures that had failed to heal after one or more medical procedures showed an overall healing rate of 91 percent after one year. The company said 36 eligible patients with severe long-bone non-union fractures of the tibia, humerus or femur, that had failed to heal with one or more prior medical procedures, were enrolled in the study. Of those, 33 patients were followed for 12 months.

• Barrier Therapeutics Inc., of Princeton, N.J., disclosed promising results from its ongoing Phase IIa proof-of-concept study with pramiconazole, its novel oral broad-spectrum antifungal product candidate, in patients with onychomycosis (fungus) of the toenails. Pramiconazole has previously demonstrated positive results in clinical studies in tinea pedis (athlete's foot), tinea corporis (ringworm), tinea cruris (jock itch), tinea versicolor, vaginal candidiasis and seborrheic dermatitis. Results in 18 patients at week 16 of the study showed, one month after completing once-weekly treatment for 12 weeks, a marked onset of clinical improvement in total signs and symptoms (p=0.001) of onychomycosis as measured by nail plate thickening, discoloration and overall appearance of the affected toenail. Highlights from the study were presented at the 26th anniversary Fall Clinical Dermatology Conference in Las Vegas.

• Hoffmann-La Roche Inc., of Nutley, N.J., noted that results from a pivotal study published in The Lancet showed that dialysis patients were effectively switched from frequently-dosed anemia drugs to Mircera, administered up to once every four weeks. The MAXIMA study is the first randomized, comparative study to investigate the direct conversion of dialysis patients with chronic kidney disease from treatment with erythropoiesis-stimulating agents given one to three times a week to intravenous Mircera given once every two weeks or once every four weeks. The results showed that Mircera maintained hemoglobin concentrations within the target range as effectively as ESAs epoetin alfa or beta, which typically are given three times a week.

• MediciNova Inc., of San Diego, reported that results from a Phase IIa clinical study of its insomnia product candidate MN-305 failed to achieve statistical significance in its primary endpoint of reducing wake-after-sleep onset. The randomized, double-blind, placebo-controlled, four-period crossover dose-response Phase IIa study included 90 patients with primary insomnia characterized by sleep maintenance difficulties at 10 clinical centers in the U.S. The firm said it planned to terminate the evaluation of MN-305 in insomnia and would focus on out-licensing the product for psychiatric disorders.