• Argenes Inc., of Tokyo, has started a Phase I clinical study of the novel antirheumatoid arthritis agent ARG098. The study will evaluate the safety and tolerability of ARG098 in the knee joint cavity of RA patients and examine its efficacy and pharmacokinetics. ARG098 is an anti-Fas IgM monoclonal antibody that specifically targets the Fas (also known as APO-1 and CD95) molecule. Argenes licensed rights to develop the compound from Santen Pharmaceutical Co. Ltd., of Osaka, Japan, in October 2004.

• Bayhill Therapeutics Inc., of Palo Alto, Calif., said results from a Phase IIb trial showed that patients with high antimyelin basic protein antibodies in their cerebral spinal fluid had statistically significantly fewer gadolinium-enhancing lesions in their brain after treatment with 0.5 mg of BHT-3009 compared with placebo. Reductions in T2 volumes and T1 black holes also were observed in this same population. The data also demonstrated there were strong trends in those same measures when applied to the trial's intent-to-treat patient population. The Phase IIb trial is a multicenter, randomized, double-blind placebo-controlled trial of 289 patients with relapsing-remitting multiple sclerosis. Patients were dosed monthly for one year with intramuscular injections of the investigational product BHT-3009. The trial's endpoints are brain magnetic resonance imaging measures of disease activity including gadolinium-enhancing lesions, T2 lesions and T1 black holes.

• OxiGene Inc., of Waltham, Mass., reported that an ongoing Phase Ib study of its lead product candidate Zybrestat (combretastatin-A4 phosphate/CA4P), administered in combination with Avastin (bevacizumab, Genentech) to patients with advanced solid tumors appeared safe and well tolerated. It also resulted in significantly enhanced tumor blood-flow reductions as measured by DCE-MRI imaging, and demonstrated early evidence of clinical activity in the absence of concurrent cytotoxic chemotherapy. The open-label, dose-escalation study is designed to evaluate safety and tolerability, pharmacodynamics, pharmacokinetics and biomarkers associated with three dosages, 45 mg/m, 54 mg/m and 63 mg/m, in combination with bevacizumab (10 mg/kg administered every 14 days). OxiGene said it expects to complete enrollment in the current quarter and report further data from all dose cohorts 2008.

• PTC Therapeutics Inc., of South Plainfield, N.J., announced positive data from a Phase II clinical trial of PTC124 in pediatric patients with cystic fibrosis due to a nonsense mutation. The results and information emerging from long-term studies showed that treatment with PTC124 results in statistically significant improvements in a measure of the function of the CF transmembrane conductance regulator (CFTR) protein. The data were presented at the 21st North American Cystic Fibrosis Conference in Anaheim, Calif. PTC is conducting a third, open-label, dose-ranging Phase II clinical trial in pediatric CF patients in Paris to determine whether PTC124 can induce production of active CFTR protein.

• Surface Logix Inc., of Boston, said that data from a Phase I trial indicated SLx-4090, a first-in-class enterocyte-specific microsomal triglyceride transfer protein inhibitor, significantly decreased plasma levels of both triglyceride and LDL-cholesterol compared with placebo. The compound is being developed to treat dyslipidemia, abnormal levels of lipids in the bloodstream. The firm also is exploring the use of SLx-4090 in other metabolic disorders, including obesity and diabetes. The Phase I repeat-dose study is a randomized, double-blind, placebo-controlled, dose escalating/decreasing study in 10 cohorts of 12 healthy male volunteers each. A variety of dosing regimens were included in the study. For subjects receiving SLx-4090, doses ranged from 25 mg to 200 mg, and dosing frequency in active and placebo arms ranged from once daily to three times daily. Treatment periods ranged from five to 14 days.