• AVIR Green Hills Biotechnology AG, of Vienna, Austria, has begun a Phase II study for the seasonal vaccine deltaFLU, which will be carried out at the Medical University of Vienna. Positive results from the Phase I study will be published Jan. 15, 2010, in the Journal of Infectious Diseases. The aim of the Phase II study is to optimize the vaccine dose and to substantiate the efficiency of the vaccine and its ability to trigger an immune response. The study will evaluate GHB11L1, an improved H1N1 vaccine that is expected to trigger an even better immune response than the one tested in previous Phase I studies while being equally safe and well tolerated.

• CytRx Corp., of Los Angeles, plans to initiate a Phase II proof-of-concept trial to evaluate the efficacy and safety of bafetinib (formerly known as INNO-406) in patients with high-risk B-cell chronic lymphocytic leukemia. In the trial, about 20 patients who have failed treatment with first-line agents will be administered daily oral doses of bafetinib. Patients will be monitored for clinical response, time to disease progression and cancer progression-free survival. Based on trial results, CytRx plans to conduct a larger comparative trial to further determine efficacy of the agent.

• Emisphere Technologies Inc., of Cedar Knolls, N.J., said that Novo Nordisk AS, of Copenhagen, Denmark, has initiated a Phase I trial with a long-acting oral glucagon-like peptide-1 (NN9924). The milestone releases a $2 million payment from Novo Nordisk to Emisphere, whose Eligen Technology is used in the formulation of NN9924. The aim of the trial, which is being conducted in the UK, is to investigate the safety, tolerability and bioavailability of NN9924 in healthy volunteers. The trial will enroll about 155 individuals, and results are expected in 2011.

• TCA Cellular Therapy, of Covington, La., said the FDA approved its adult stem cell protocol to conduct Phase I trials to treat amyotrophic lateral sclerosis. In the trial, adult stem cells will be taken from the patient's bone marrow in an outpatient procedure, processed in TCA-CT's GMP laboratory and administered to the patient by spinal tap in one of TCA-CT's facilities. Recruitment of patients will begin in the next few weeks, and the company anticipates moving into Phase II within a year. This is the second FDA-approved stem cell trial for ALS. In September, Neuralstem Inc., of Rockville, Md., received an FDA go-ahead.