• Aradigm Corp., of Hayward, Calif., said the FDA conferred orphan drug status on a liposomal formulation of ciprofloxacin for cystic fibrosis. The product, an aerosolized formulation of the anti-infective drug, is designed to increase its residence time in the lung and prolong its anti-infective properties in order to treat related infections.

• Bascom Palmer Eye Institute at the University of Miami reported one-year results of a 40-patient study of South San Francisco-based Genentech Inc.'s Lucentis (ranibizumab) ocular injection in neovascular age-related macular degeneration. Results from the PrONTO (Prospective Optical Coherence Tomography Imaging of Patients with Neovascular Age-Related Macular Degeneration Treated with Intra-Ocular Lucentis) showed that the average patient received five or six injections over a one-year period, with retreatment determined with OCT imaging technology. Overall, average vision improved in the treated eye almost two lines after one year, and 82 percent of patients had the same or better vision after one year. About 35 percent experienced a twofold improvement in vision, as defined by gaining three lines of vision on a standardized visual acuity chart. Lucentis, an investigational drug designed to bind and inhibit VEGF-A, is under review at the FDA in wet AMD.

• Eisai Medical Research Inc., a subsidiary of Eisai Co. Ltd., of Tokyo, is beginning an initial Phase I trial of E2012, a gamma secretase modulator that is being evaluated as a treatment for Alzheimer's disease. In preclinical research, the new chemical entity has shown some potential to reduce the production of beta-amyloid by modulating the function of gamma secretase.

• Gendux AB, of Stockholm, Sweden, submitted an orphan drug designation request to the European Medicines Evaluation Agency for the use of Advexin p53 therapy in cancer patients with Li-Fraumeni syndrome. The rare inherited genetic disorder increases the risk of developing several types of cancer, typically with initial occurrence at a young age. Gendux is a wholly owned subsidiary of Introgen Therapeutics Inc., of Austin, Texas.

• Genitope Corp., of Redwood City, Calif., said a Phase I/II study of MyVax has gotten under way in chronic lymphocytic leukemia patients. Enrollment will include about 70 patients who will receive a series of 16 injections of their custom-made vaccine over a 52-week period. The idiotype immunotherapy is based on the genetic makeup of a patient's tumor to activate the individual's immune system.

• Nutra Pharma Corp., of Boynton Beach, Fla., said its holding, ReceptoPharm, received approval from the Medicines Health and Regulatory Agency within the British Department of Health for clinical trials in adrenomyeloneuropathy, a rare inherited metabolic disorder that can lead to neurological disability. ReceptoPharm's drug candidate, RPI-78M, was found to be safe and well tolerated in a 2003 study in the UK. The upcoming trial, set to begin by the end of the summer, is intended also to provide additional safety data in support of other trials, such as Phase I/II studies of the drug in multiple sclerosis.

• Scios Inc., of Fremont, Calif., said findings reported at the Scientific Forum on Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke meeting in Washington showed that the maximum mean increase in serum creatinine (SCr) from baseline was 0.15+/-0.29 mg/dL in Natrecor (nesiritide) patients compared to 0.34+/-0.48 mg/dL in placebo patients (p<0.001). The difference was even greater in patients who had some degree of renal dysfunction before surgery. Also, the maximum decrease in glomerular filtration rate from baseline was -10.8 mL/min/1.73 m2 in nesiritide patients compared to -17.2 mL/min/1.73 m2 in placebo patients (p=0.001). Scios is part of Johnson & Johnson, of New Brunswick, N.J.