• AVI BioPharma Inc., of Portland, Ore., said that the Imperial College of London and UK-based MDEX Consortium have received approval from the UK Medicines and Healthcare Products Regulatory Agency to start screening patients for a proof-of-principle dose-escalating clinical trial of AVI-4658. The trial will include up to nine boys with Duchenne muscular dystrophy, each of whom will receive a single intramuscular administration of the drug. Two to three weeks following the injection, the muscle will be biopsied and examined for molecular evidence of improved dystrophin production.

• CombinatoRx Inc., of Cambridge, Mass., said that results of a Phase IIa of CRx-102 (dipyridamole and prednisolone) showed it is effective at reducing pain in hand osteoarthritis. Based on those results the firm said it recently initiated a Phase IIb trial to evaluate efficacy in subjects with symptomatic knee osteoarthritis. CRx-102, an oral synergistic combination drug candidate with a novel multitarget mechanism that inhibits key cell mediators of inflammation, also will be tested in rheumatoid arthritis in a separate Phase IIb study.

• Favrille Inc., of San Diego, said its independent data monitoring board (DMB) recently assessed time to tumor progression (TTP) for patients in the control group of the firm's pivotal Phase III clinical trial of FavId, an active immunotherapy based on unique genetic information extracted from a patient's tumor. The product is designed to stimulate a patient's immune system to mount a specific and sustained response to disease. Based in part on the guidance provided by the DMB, Favrille said it has determined April 2008 to be the appropriate data cutoff date for the trial. The firm said it anticipates that the analysis of the data will be completed and made available no later than July 2008. The trial is a randomized, double-blind, placebo-controlled study of FavId following Rituxan (rituximab) treatment in patients with follicular B-cell non-Hodgkin's lymphoma.

• LifeCycle Pharma AS, of Horsholm, Denmark, said that interim results of a Phase II trial showed that LCP-Tacro (tacrolimus), a once-a-day immunosuppressant treatment for transplant patients, was superior to Prograf (tacrolimus), a twice-a-day therapy marketed by Japan-based Astellas Pharma. The interim data are from 10 patients. The firm plans to enroll 40 additional patients in the ongoing Phase II trial and plans to initiate a Phase III study in 2008 in de-novo kidney and stable kidney transplant recipients. Top-line results from the Phase II clinical trial are expected by year end or early 2008.

• Panacos Pharmaceuticals Inc., of Watertown, Mass., said that preliminary results from a Phase IIb study showed that patients who received 300 mg of bevirimat (PA-457) had a mean viral load reduction of 1.02 log10 after 14 days of therapy, the primary endpoint of the study. The drug is being tested in patients who failed HIV therapy due to drug resistance. The 300-mg cohort had a greater viral load reduction than the previous cohort where patients were dosed with a 250-mg bevirimat solution, and a mean viral load reduction of 0.68 log10 was observed, the firm reported. Following final review of the safety data and FDA confirmation, Panacos intends to proceed to the next cohort, in which treatment-experienced patients will receive a 350-mg bevirimat solution or placebo on top of their failing background regimen daily for two weeks.