• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., initiated a Phase I trial of an RNAi treatment for respiratory syncytial virus (RSV) infection, ALN-RSV01, in the U.S. The inhaled treatment will be administered in a nebulized formulation on healthy adults. Two previous Phase I studies tested the drug in an intranasal form.
• Aspreva Pharmaceuticals Corp., of Victoria, British Columbia, reported data from an 80-patient investigator initiated trial at Duke University Medical Center with The Muscle Study Group, a consortium of academic centers in Durham, N.C. The double-blind, placebo-controlled trial, supported by Aspreva, the FDA and Aspreva's partner, F. Hoffmann-La Roche Ltd., of Basel, Switzerland, evaluated the effect of the start of treatment with prednisone and CellCept (mycophenolate mofetil, or MMF) compared to prednisone alone on the signs and symptoms of myasthenia gravis in patients who were not on corticosteroids and had not previously received other immunosuppression. After 12 weeks of treatment, the efficacy of MMF and 20 mg of prednisone was no different from the efficacy of 20 mg of prednisone alone.
• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., said data reported at the North American Menopause Society meeting in Nashville, Tenn., showed a clear dose response to Bio-E-Gel (transdermal estradiol gel) in reducing the number and severity of hot flashes in the low, mid and high doses tested.
• CoGenesys Inc., of Rockville, Md., dosed the first patient in a Phase I/II trial with Cardeva, a long-acting form of B-type natriuretic peptide being developed for heart failure. The ascending, repeat-dose safety and tolerability trial will enroll up to 80 stable subjects with Class II or Class III heart failure, and subjects will receive one or two doses of Cardeva or vehicle control.
• Osiris Therapeutics Inc., of Baltimore, won regulatory approval to expand patient enrollment into Canada for its ongoing Phase III pivotal trial evaluating Prochymal for the treatment of graft vs. host disease.
