• Acceleron Pharma Inc., of Cambridge, Mass., initiated a Phase II trial with ACE-031 in patients with Duchenne's muscular dystrophy. ACE-031 is designed to build muscle and increase strength by inhibiting signaling of a cell surface receptor called the activin receptor type IIB. The study is being conducted at multiple sites in Canada. Acceleron is in discussions with regulatory authorities in several other countries regarding possible expansion of the study into those countries.

• Lithera Inc., of San Diego, reported positive results from a Phase IIa study of LIPO-102, its injectable combination of salmeterol xinafoate (SX) and fluticasone propionate (FP) for selective, nonablative fat reduction. The effects of the optimal dose of LIPO-102 (1 mcg SX + 22 mcg FP) on abdominal circumference and volume persisted for six to 12 weeks post-treatment.

• Romark Laboratories LC, of Tampa, Fla., reported results from its STEALTH C-3, a Phase II study of nitazoxanide in treatment-naive patients with genotype 1 chronic hepatitis C. In the study, 112 patients were randomized to receive either nitazoxanide (500 mg twice daily) plus peginterferon alfa-2a (Pegasys, Roche) and ribavirin (Copegus, Roche) or placebo plus Pegasys and Copegus. The primary endpoint of the study was sustained virologic response (SVR, undetectable hepatitis C virus RNA 24 weeks after the end of treatment). SVR occurred in 44 percent of patients treated with nitazoxanide plus standard therapy for 48 weeks vs. 32 percent of patients treated with placebo plus standard therapy. SVR rates were consistently higher in subsets of patients with high baseline viral load (41 percent vs. 29 percent) and in African Americans (38 percent vs. 20 percent). The study results were presented at the American Gastroenterological Association Institute during Digestive Disease Week in New Orleans.

• Scancell Holdings plc, of Nottingham, UK, said that its proposal to conduct a Phase I trial on SCIB1, its DNA ImmunoBody vaccine being developed for the treatment of melanoma, has been approved in the UK by the Gene Therapy Advisory Committee and by the Medicines and Healthcare products Regulatory Agency Medicines Division. In addition, Scancell's U.S. partner, Ichor Medical Systems Inc., of San Diego, has obtained the required parallel approval from the MHRA Devices Division for the use of Ichor's TriGrid electroporation delivery device to administer SCIB1 to patients participating in the trial of SCIB1. Recruitment for the Phase I trial of SCIB1 is expected to commence shortly in the UK.

• Vical Inc., of San Diego, said it has enrolled the first subject in its Phase I trial of the company's Vaxfectin-formulated plasmid DNA pandemic influenza vaccine. The trial will be conducted in collaboration with the U.S. Naval Medical Research Center. The trial will enroll about 30 healthy adult volunteers at a single U.S. clinical site.