• Arena Pharmaceuticals Inc., of San Diego, reported positive results from a single-dose Phase Ia trial of APD791, which showed that doses were well tolerated up to 320 mg, and no maximum tolerated dose could be defined despite achieving high concentrations of the drug in blood. The company intends to move into a multiple-dose Phase Ib trial in up to 50 healthy volunteers to further evaluate APD791's pharmacokinetics and pharmacodynamics. Results are expected in mid-2008. APD791, a selective inverse agonist of the 5-HT2A serotonin receptor, is designed to treat arterial thrombosis.

• DeCODE Genetics, of Reykjavik, Iceland, said results from its Phase IIa clinical trial for DG051, a leukotriene A4 hydrolase inhibitor, confirmed that the compound delivers significant dose-dependent reductions in leukotriene B4 in patients with a history of heart attack or coronary artery disease who were taking a variety of concomitant medications. The pharmacokinetic and safety profiles of the compound were favorable and similar to those seen in previous studies in healthy volunteers. There were no serious adverse events in the study. The firm plans to start a Phase IIb double-blind, placebo-controlled study of 400 patients this spring to further examine DG051's pharmacokinetic and pharmacodynamic parameters and the safety and tolerability of the compound.

• Emergent BioSolutions Inc., of Rockville, Md., said it is progressing into the next stage of the enrollment of patients in its study of a hepatitis B immunotherapy based on recommendations from an independent safety monitoring committee. In the study, 45 patients with chronic hepatitis B virus infection are being randomized within three separate groups to receive immunotherapy or placebo. The immunotherapy uses the company's proprietary spi-VEC delivery system to deliver the hepatitis B core antigen, in order to induce an immune response to the virus. The firm said it anticipates having preliminary top-line safety and efficacy data by the end of 2008 and complete study results by the first half of 2009.

• MethylGene Inc., of Montreal, and Pharmion Corp., of Boulder, Colo., said the first patient has been enrolled in a Phase II clinical trial evaluating MGCD0103, an isotype-selective histone deacetylase inhibitor, in combination with Pharmion's Vidaza (azacitidine for injection), a DNA demethylating agent, in patients with relapsed or refractory Hodgkin's lymphoma or non-Hodgkin's lymphoma. Patients will receive 75 mg/m2 of Vidaza either intravenously or subcutaneously in combination with an oral dose of MGCD0103 in 28-day cycles. Key objectives are the overall response rate, progression-free survival and duration of response. The trial will enroll up to 75 patients at cancer centers in North America and will include a pharmacokinetic equivalency study.

• Rigel Pharmaceuticals Inc., of South San Francisco, said it started enrolling patients in a Phase I study to evaluate the safety and tolerability of R348, an orally available, inhibitor of Janus kinase 3, as a potential treatment for patients with rheumatoid arthritis, psoriasis and other immune disorders. The study will evaluate the safety and pharmacokinetics of R348 in young, healthy males using a double-blind, placebo-controlled, single-dose and multiple-rising doses of R348. Results are expected in mid-2008.

• Tracon Pharmaceuticals Inc., of San Diego, said it has dosed the first three cancer patients in a Phase I clinical trial of TRC105, a first-in-class human chimeric monoclonal antibody that inhibits tumor growth by binding to CD105, a receptor overexpressed on proliferating endothelium that is required for angiogenesis. TRC105 has shown activity, as monotherapy or when combined with chemotherapy, in preclinical studies of breast and colorectal cancer, the firm said, adding that preclinical data also indicated CD105 expression is increased following treatment of human cancer with antivascular endothelial growth factor therapy.

• Vivus Inc., of Mountain View, Calif., initiated a six-month extension study of OB-202, a 28-week, randomized, double-blind, placebo-controlled, efficacy and safety study of Qnexa in the glycemic management of obese patients with Type II diabetes. The newly initiated study, DM-230, will allow participants to continue, in a blinded fashion as randomized, in the study for an additional 28 weeks. The primary endpoint will be improvement of glycemic control as measured by a reduction of glycosylated hemoglobin, or HbA1c, levels. The randomized, double-blind, parallel-designed study also will measure the effects of Qnexa on associated metabolic and cardiovascular risk factors and changes in total body weight, percent of baseline body weight lost and a change in waist circumference.

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