• Avir Green Hills Biotechnology, of Vienna, Austria, has started the first clinical Phase I study for its influenza vaccine FluVacc, which is based on the deletion of the NS1 gene. The first eight volunteers were vaccinated in collaboration with the Medical University Vienna at the General Hospital. The study will investigate the pharmacological effect of the vaccine obtained in animal models, in humans. The main aim is to test the safety of that type of vaccine administered as a single immunization in the form of a nasal spray.

• BioLineRx Ltd., of Jerusalem, said it has begun a study to determine the clinical binding properties of BL-1020 to the dopamine receptors in the human brain. The trial, being conducted under an investigational new drug application with the FDA, is a single-center, randomized, open-label, sequential cohort clinical study to be conducted at Uppsala, Sweden. The results will provide further data related to the anticipated efficacy of the BL-1020 compound - the first GABA enhanced antipsychotic clinical candidate for the treatment of schizophrenia. The trial also will supply additional safety, tolerability and pharmacokinetic data. The company expects to initiate its Phase II maximal tolerated dose clinical trial for BL-1020 by the end of June. The Phase II trial sites will already will been selected in Romania and Israel, and an investigator meeting is planned for mid-June.

• Can-Fite BioPharma, of Petach Tikva, Israel, has received Ministry of Health and EC approval at several medical centers to begin phase II clinical trials with its leading drug CF101 in patients with psoriasis. The trial will involve approximately 60 patients, who will be treated for about 12 weeks at four medical centers. It is the third indication for CF101, in addition to rheumatoid arthritis and dry eye syndrome, which already are in advanced clinical trial phases. The company expects that the trial will be completed in the first quarter of 2008. In addition, the company reported the completion of the Phase IIb clinical trial with CF101 for the treatment of rheumatoid arthritis. The data obtained in the trial currently are subjected to statistical analysis by ABR New Jersey, and Can-Fite plans to release a final report of study results this summer.

• Cardium Therapeutics Inc., of San Diego, started recruiting patients for its Phase III AWARE (Angiogenesis in Women with Angina pectoris who are not candidates for Revascularization) trial of Generx (alferminogene tadenovec, Ad5FGf-4) in women for the potential treatment of myocardial ischemia. The randomized, placebo-controlled, double-blind trial is expected to enroll about 300 patients with recurrent stable angina pectoris who are receiving optimal drug therapy. The primary endpoint is the improvement in time to onset of electrocardiogram changes diagnostic of myocardial ischemia during exercise treadmill testing at six months following administration. Secondary endpoints are the improvement in myocardial blood flow within the affected heart muscle measured by adenosine SPECT (single photon emission computed tomography) imaging and improvements in other measures of angina. Generx is an angiogenic therapeutic designed to promote the heart's natural response of collateral growth and to increase blood flow in the microcirculation.

• Celgene Corp., of Summit, N.J., said the Southwest Oncology Group (SWOG) permanently closed enrollment in a federally funded Phase III clinical trial comparing a standard drug therapy, dexamethasone, with a combined therapy of dexamethasone plus Revlimid (lenalidomide) for patients newly diagnosed with multiple myeloma. Additionally, SWOG announced that current participants in the SWOG study, called S0232, be given the choice of switching to Revlimid with dexamethasone. According to SWOG, the 198 patients enrolled in the trial, prior to the closure, are sufficient to provide data analysis and evaluate the primary endpoint of progression-free survival (PFS) in the two arms of the trial.

• Genzyme Corp., of Cambridge, Mass., completed enrollment of its ongoing Phase II trial of Genz-112638, an oral therapy in development for Gaucher's disease, and based on positive results seen to date, the company intends to meet with regulatory agencies in the coming weeks to discuss an expedited development strategy. Initial observations from the first five patients suggested that the drug might produce a rapid and meaningful impact on clinical endpoints such as reductions in spleen and liver volume and an increase in platelet counts and hemoglobin concentration. Full trial results are expected in mid-2008. Genz-112638 is a ceramide analogue designed to inhibit the enzyme glucosylceramide synthase to reduce the production of the glucocerebroside that builds up in the cells and tissues of Gaucher's disease patients.

• InterMune Inc., of Brisbane, Calif., completed patient enrollment for CAPACITY, its Phase III clinical program to evaluate pirfenidone for patients with idiopathic pulmonary fibrosis (IPF). The enrollment was finished seven months ahead of schedule and with 194 more patients than planned. The program includes two multinational, randomized, double-blind, placebo-controlled Phase III trials, CAPACITY 1 and CAPACITY 2, designed to evaluate the safety and efficacy of pirfenidone in IPF patients with mild to moderate lung function impairment. The primary endpoint of both trials is lung function. The two trials have enrolled a total of 779 patients at 110 centers in North America and Europe. Top-line results are expected around the end of 2008. IPF is a disabling and ultimately fatal disease that affects approximately 83,000 people in the U.S., with about 30,000 new cases developing each year. There are no drugs approved in the U.S. or Europe for the treatment of IPF.

• Obecure Ltd., of Ramat Gan, Israel, launched a Phase II trial to test OBE101 in improving the plasma lipid profiles of patients treated with Simvastatin, a generic cholesterol-lowering drug. The company believes OBE101, which is in development for weight management, could benefit patients taking Simvastatin by providing an anti-fat craving effect. The four-week study is expected to enroll about 30 subjects who are treated stably with Simvastatin and randomize them into one of two treatment arms: one to receive the drug twice daily and a control arm to receive a placebo. Primary endpoints will include a statistically significant reduction in LDL levels from baseline in treated patients over placebo, as well as a significant difference between treatment and placebo in the percentage of patients whose LDL levels are reduced by greater than 10 percent. OBE101 also is in two ongoing trials, one in obesity and one to prevent weight gain in patients taking the antipsychotic drug Zyprexa.

• Trophos Sa, of Marseille, France, enrolled the first patients in its Phase IIa trial of TRO19622, its lead product identified using the neuronal cell screening platform, in diabetic neuropathy. The 180-patient study is designed to compare the efficacy of TRO19622 to placebo after six weeks of treatment, with the primary endpoint defined as symptomatic pain relief as measured on the 11-point Likert scale on daily diary, as well as a number of other pain scales. Trophos expects to complete the study in the first half of 2008.