• Aradigm Corp., of Hayward, Calif., said data from a Phase I study of healthy subjects and a Phase IIa study in cystic fibrosis patients showed that its inhaled liposomal ciprofloxacin demonstrated similar pharmacokinetics, with a long systemic elimination half-life of ~ 10.5 hours supporting a once-daily dosing regimen. Treatment also resulted in significant reduction in the sputum of Pseudomonas Aeruginosa colony-forming units, a measure of the reduction in pulmonary bacterial load in CF patients. Data were presented at the European Cystic Fibrosis conference in Brest, France.

• Biopartners GmbH, of Baar, Switzerland, and LG Life Sciences Ltd., of Seoul, South Korea, presented positive Phase III, placebo-controlled six-month efficacy and safety data in adults with growth hormone deficiency for LB03002, a once-a-week, sustained-release recombinant human growth hormone. Data showed the statistically significant superiority of LB03002 over placebo, with a low incidence of adverse events. Compared to placebo, LB03002 demonstrated superiority in the reduction of fat mass, with positive impact on the reduction of trunk fat mass and an increase in lean body mass. LB03002 was also effective in producing notable increases in serum IGF-1 levels in adult patients with growth hormone deficiency. Data were presented at the annual meeting of the Endocrine Society in Washington.

• Biota Holdings Ltd., of Melbourne, Australia, said it achieved proof of concept in a Phase IIa study of BTA798, an oral inhibitor of human rhinovirus, which showed that the drug was able to reduce the incidence and severity of HRV infection compared to placebo. The study involved 41 healthy male subjects who had no evidence of immunity to the HRV study virus prior to experimental virus exposure. The primary endpoint was the incidence of confirmed HRV infection, with measures of viral count, symptom improvement, safety and pharmacokinetics as secondary endpoints. Biota expects to discuss plans for future studies in patients with naturally acquired HRV infection.

• Enobia Pharma Inc., of Montreal, said positive results were reported from a Phase I safety trial of ENB-0040 in hypophosphatasia in adults, and early safety and efficacy findings from an ongoing study in severely affected infants. After an initial single intravenous dose, the patients received thrice-weekly subcutaneous doses of ENB-0040 for up to six months. So far X-rays at three months showed substantial new mineralization in the ribs, wrists, knees and long bones in the first three of five patients. The patients' overall clinical status also improved with most showing improved growth and requiring less respiratory support. No drug-related serious adverse events were reported in either study, and no patients developed anti-ENB-0040 antibodies. The results were reported at The Endocrine Society's annual meeting in Washington.

• Genetic Immunity LLC, of Budapest, Hungary, said it completed enrollment in a Phase II trial of DermaVir Patch in treatment-naïve HIV-1-infected patients. A total of 36 patients have been recruited in the trial, which is designed to test the safety and tolerability DermaVir Patch, a plasmid DNA-based nanomedicine vaccine candidate, as the primary endpoint. Secondary endpoints include HIV-1 RNA measurements to assess the antiretroviral activity and changes in CD4+ and CD8+ T-cell counts.

• GTx Inc., of Memphis, Tenn., reported positive results from a Phase II trial evaluating Ostarine (MK-2866), a selective androgen receptor modulator, in patients with cancer-induced muscle loss. Ostarine treatment led to statistically significant increases in lean body mass and improvement in muscle performance measured by stair climb compared to baseline in both the Ostarine 1-mg and 3-mg treatment cohorts.

• Medivation Inc., of San Francisco, said it completed patient enrollment in the CONNECTION study, a six-month, confirmatory, pivotal Phase III trial of dimebon in patients with mild-to-moderate Alzheimer's disease. The international, double-blind, placebo-controlled enrolled 598 patients. The company plans to submit a new drug application in 2011. A Phase III safety study being conducted could allow Medivation and partner Pfizer Inc., of New York, to seek marketing approval earlier depending on trial results.

• Neurim Pharmaceuticals, of Seattle, said preliminary results of a large-scale Phase III study of Circadin 2 mg, a prolonged-release melatonin, demonstrated improvements in sleep latency, quality of sleep and morning alertness, particularly in elderly patients, with no withdrawal symptoms and rebound insomnia.

• Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., and its partner Sanofi-Aventis Group, of Paris, said results of a randomized, placebo-controlled Phase II trial showed that patients with recurrent symptomatic malignant ascites receiving aflibercept experienced a statistically significant improvement in mean time to first repeat paracentesis, or removal of fluid from the abdominal cavity, vs. placebo, meeting the primary endpoint. Mean time to first repeat paracentesis following a baseline procedure was 55 days with aflibercept, compared with 23 days for patients receiving placebo (p = 0.0019).

• VIA Pharmaceuticals Inc., of San Francisco, said it completed an end-of-Phase-IIa meeting with the FDA for VIA-2291 (atreleuton), a selective and reversible inhibitor of 5 Lipoxygenase, a key enzyme in the biosynthesis of leukotrienes. The firm said regulators provided guidance on the company's trial design for its Phase III study, which will assess the effect of VIA-2291 in preventing cardiovascular events such as heart attack, stroke and cardiovascular mortality in patients with recent heart attack or established atherosclerotic cardiovascular disease. VIA said it intends to submit its proposed Phase III plan to the FDA, including a request for a special protocol assessment. The firm noted that it currently is exploring strategic opportunities for launching the drug's final phase of development. Shares of VIA (NASDAQ:VIAP) rose 8 cents, or 12.5 percent, to close at 70 cents.

• Wyeth Pharmaceuticals, of Collegeville, Pa., said new data from Phase III European trials reinforced that Prevenar 13 (pneumococcal polysaccharide conjugate vaccine, 13-valent; adsorbed), has the potential to provide coverage against the 13 most prevalent serotypes associated with pneumococcal disease, the leading cause of vaccine-preventable death in children younger than 5 worldwide. Prevenar 13 includes the seven serotypes that are in the firm's Prevenar (pneumococcal polysaccharide conjugated vaccine; adsorbed), which is the current global standard in pneumococcal disease prevention in infants and young children, plus six additional serotypes associated with the greatest remaining burden of invasive disease. Both Prevenar 13 and Prevenar use CRM197, an immunological carrier protein with a 20-year history of use in pediatric vaccines.