• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., filed a clinical trial application with the Medicines and Healthcare products Regulatory Agency for a Phase I trial of ALN-PCS, an RNAi therapeutic for treating severe hypercholesteremia. About 32 healthy volunteers with elevated baseline LDL cholesterol (> 116 mg/dL) will be enrolled, and the primary objective is to evaluate safety and tolerability of a single dose. Secondary objectives include characterization of plasma and urine pharmacokinetics, and assessment of pharmacodynamic effects on plasma PCSK9 protein and LDL levels measured from serial blood samples prior to and following dosing. Data are expected before the end of this year.

• Celsion Corp., of Columbia, Md., said the independent data monitoring committee recommended continuation of the firm's Phase III study of ThermoDox in combination with radiofrequency ablation in primary liver cancer following a review of 535 randomized patients. The company also reported that enrollment in the trial, dubbed HEAT, has reached 98 percent of the 600 patients necessary for the study. Progression-free survival is the primary endpoint. ThermoDox is a heat-activated liposomal encapsulation of doxorubicin.

• SuppreMol GmbH, of Martinsried, Germany, initiated a Phase IIa trial of SM101, a recombinant human soluble Fcy receptor IIb, in systemic lupus erythematosus (SLE). The study is expected to enroll 50 SLE patients with or without a history of lupus nephritis and a SELENA-SLEDAI score of greater than or equal to 6 and active serological status. The primary endpoint is safety. Efficacy will be determined by overall and renal disease score assessments, proteinuria, urine sediment, a number of biochemical, biological and molecular markers and the use of rescue medication. Data are expected in 2013.