• Anthera Pharmaceuticals Inc., of San Mateo, Calif., started enrolling patients with stable coronary artery disease in its Phase II trial of A-002, an inhibitor of secretory phospholipase A2 (sPLA2). The PLASMA (Phospholipase Levels And Serological Markers of Atherosclerosis) study will randomize about 200 subjects to receive either placebo tablets or one of four orally active doses of A-002 for eight weeks. The study's goal will be to determine A-002's ability to target sPLA2, enzymes that lead to the release of damaging free fatty acids and lysophospholipids, both of which are involved in the inflammatory process.

• Ceregene Inc., of San Diego, confirmed that enrollment is under way in its Phase II trial of CERE-120, a gene therapy product in development for Parkinson's disease. A total of 51 patients with advanced Parkinson's will be involved in the study, with two-thirds to receive CERE-120 via stereotactic neurosurgery and one-third to get placebo. Patients will be followed for 12 months for safety and efficacy results. CERE-120 is composed of an adeno-associated virus vector carrying the gene for neurturin, a naturally occurring protein known to repair damage and dying dopamine-secreting neurons.

• Genmab A/S, of Copenhagen, Denmark, initiated a Phase II study of HuMax-EGFr (zalutumumab) in combination with chemo-radiation to treat non-small-cell lung cancer. The study will include up to 270 previously untreated patients with advanced NSCLC. The first part of the open-label study will include at least 24 patients treated with the drug, chemotherapy and radiation therapy. The study will evaluate safety and efficacy of the combination vs. chemo-radiation alone. The primary endpoint is progression-free survival from randomization until disease progression or death.

• Idenix Pharmaceuticals Inc., of Cambridge, Mass., and Novartis AG, of Basel, Switzerland, reported results from a comparative study showing that their hepatitis B drug, Sebivo (telbivudine), provided more rapid and profound viral suppression than adefovir both in newly diagnosed HBeAg-positive patients and in those who switched from adefovir to Sebivo. Data also showed that, regardless of treatment, a substantial early reduction in virus level correlated with better outcomes, including maintained undetectable levels of virus (PCR-negativity), HBeAg seroconversion and ALT normalization, at one year. A significantly greater percentage of Sebivo patients achieved PCR-negativity (38 percent) compared to adefovir-treated patients (12 percent) by six months. Findings were presented at the European Association for the Study of the Liver meeting in Barcelona, Spain.

• Intarcia Therapeutics Inc., of Mountain View, Calif., disclosed final results of a Phase II study of omega interferon with or without ribavirin in treatment-naive patients with genotype 1 chronic hepatitis C virus. Results demonstrated the combination was well tolerated and showed robust antiviral activity, comparable to published data on the use of alpha interferon plus ribavirin in similar patients. Omega interferon was delivered with Duros technology, which is designed to deliver a continuous and consistent dose of omega interferon for three months via an implantable device.

• MediGene AG, of Martinsried, Germany, initiated a Phase II trial of EndoTAG-1 in triple receptor-negative breast cancer, with the goal of evaluating the product's efficacy. Patients will be randomized into three groups - treatment with EndoTAG-1 only, treatment with EndoTAG-1 in combination with chemotherapy and treatment with chemotherapy only. The primary endpoint is progression-free survival rate after 16 weeks. Results are expected in 2009. EndoTAG-1, a combination of paclitaxel and a delivery system made up of cationic lipids, is designed to specifically destroy the blood vessels of tumors. MediGene also has an ongoing Phase II study of the product in pancreatic cancer.

• ViroPharma Inc., of Exton, Pa., said additional data from a Phase Ib study of HCV-796, an oral HCV polymerase inhibitor, in combination with pegylated interferon alfa-2b demonstrated additive antiviral effects of the drug across multiple genotypes of hepatitis C virus in treatment-naïve adults with chronic HCV infection. HCV-796 dosed twice daily, plug Peg-IFN, showed clinical antiviral activity that is greater than that of HCV-796 or peg-IFN alone. Final safety and tolerability data showed that the drug is generally well tolerated and no dose-limiting toxicities were observed in the range of study doses. Those results were presented at the European Association of the Study of the Liver in Barcelona, Spain. ViroPharma and partner, Madison, N.J.-based Wyeth Pharmaceuticals, are evaluating HCV-796 in an ongoing Phase II study.