• AVEO Pharmaceuticals Inc., of Cambridge, Mass., started patient enrollment in a Phase II exploratory biomarker study of tivozanib, a VEGF inhibitor, in patients with renal-cell carcinoma (RCC). The single-arm trial is designed to evaluate biomarkers of tivozanib in about 100 patients with RCC who had a prior nephrectomy. A primary objective is to evaluate biomarkers in blood and archived tissue samples and their correlation with tivozanib clinical activity and/or drug-related toxicity.

• Bavarian Nordic A/S, of Kvistgard, Denmark, completed a Phase II trial of smallpox vaccine Imvamune in subjects suffering atopic dermatitis, who are at increased risk of severe side effects from conventional replicating smallpox vaccines. The 350-patient study showed that vaccination with Imvamune was well tolerated, and subjects with atopic dermatitis generated strong vaccinia-specific immune responses similar to healthy subjects. Funding came from the National Institute of Allergy and Infectious Diseases.

• Circassia Ltd., of Oxford, UK, said its ToleroMune cat allergy treatment significantly reduced patients' symptoms in a Phase II trial. The study also confirmed that the treatment had a favorable safety profile. A total of 202 cat allergy patients were randomized in the trial to receive either four or eight standardized doses of Circassia's T-cell vaccine or placebo. The key group, which received four doses of the vaccine over a period of 12 weeks, experienced a 55 percent greater improvement in their symptoms despite a higher-than-expected placebo effect.

• Hutchison MediPharma Ltd., of London, a subsidiary of Chi-Med, received investigational new drug application approval from the SFDA of China and began a Phase I trial of its cancer product, fruquintinib, or HMPL-013. The company said the compound suppresses angiogenesis, and it is being developed for hard-to-treat tumors such as pancreatic cancer and melanoma. The open-label, dose-escalation study is being carried out in China. It will investigate the maximum tolerated dose of fruquintinib and assess safety and tolerability.

• Medicago Inc., of Quebec City, reported interim results from a Phase II trial of its H5N1 avian influenza virus-like particle vaccine candidate, showing that it was safe, well tolerated and induced a solid immune response. The study enrolled 135 healthy volunteers immunized with the vaccine at three dosage levels. No serious adverse events were reported and, in those vaccinated in the 18 to 49 age group at the 20 mcg dosage level, 82 percent developed an immune response against the H5N1 virus after the second immunization, while 65 percent of subjects had a fourfold increase in HI titers from baseline and 65 percent had seroprotective antibody titers. Medicago plans to proceed with the second part of its Phase II study, with final data expected in the second half of this year.

• Prima BioMed Ltd., of Melbourne, Australia, said the first seven patients have completed the first treatment cohort in its Phase IIb trial of CVac immunotherapy ovarian cancer vaccine, and no safety data concerns were expressed by the data safety monitoring board. Patient enrollment in the randomized component of the trial is now open, and the firm expects enrollment to the full 60-patient complement.

• VBL Therapeutics Inc., of Tel Aviv, Israel, started two studies of VB-111, a targeted, dual-action anti-angiogenic and vascular disruptive agent, in advanced cancers. The first, a Phase IIa study, will test VB-11 in advanced differentiated thyroid cancer, enrolling up to 82 patients to assess efficacy, safety and tolerability. The second study, a Phase I/II trial, will evaluate the drug in relapsed glioblastoma multiforme. That trial will evaluate progression-free survival at six months, examine the biodistribution of VB-111 in the body and assess safety and tolerability.