• AlphaVax Inc., of Research Triangle Park, N.C., began immunizing volunteers in trials to evaluate vaccines for cytomegalovirus (CMV) and influenza developed with the company's alphavaccine technology. In the first, they're receiving a human version of an alphavaccine that's shown to be effective in protecting against congenital CMV disease in a preclinical study. Results will be used to design future studies in target populations such as solid organ transplant recipients. In the second, volunteers are being immunized with a flu alphavaccine that contains the hemagglutinin gene from a single flu strain and has been shown to be effective in protecting animals against experimental infection. Subsequent trials will test additional vaccine candidates for seasonal and potentially pandemic flu strains.

• Clinuvel Pharmaceuticals Ltd., of Melbourne, Australia, received Swiss regulatory clearance to begin a randomized, placebo-controlled Phase III trial of CUV1647 in erythropoietic protoporphyria, a rare genetic disorder that results in absolute sun intolerance. The trial will enroll between 50 and 70 patients in Europe and Australia and will evaluate reduction in the number and severity of phototoxic skin reactions. In January, Clinuvel announced clearance to begin a Phase III trial of CUV1647 in polymorphic light eruption, or sun poisoning.

• MacroChem Corp., of Wellesley Hills, Mass., has completed enrollment in a 40-patient, open-label Phase II efficacy study of EcoNail, a topical antifungal lacquer for the treatment of onychomycosis (nail fungus). EcoNail contains the antifungal econazole and MacroChem's enhancer SEPA. Patients at centers around the U.S. participating in the study, which is being conducted under an Investigational New Drug application, will receive 48 weeks of treatment. Evaluation of 24-week data will come later this year.

• Obecure Ltd., of Ramat Gan, Israel, has completed enrollment of patients for its Phase II trial to evaluate the efficacy of the company's OBE101 drug candidate for weight loss in obese patients. The double-blinded, placebo-controlled, dose-ranging study is being conducted at 20 medical sites across the U.S. with 281 patients. The drug will be administered orally, twice daily, for 12 weeks. Previous study showed that treatment of obese women with OBE101 for four weeks substantially reduced their fatty food intake and improved their weight loss, compared to placebo. In related news, the National Institutes of Health has agreed to undertake a study comprising 80 human subjects that will examine OBE101's mechanism of action by evaluating its impact on body energy consumption and expenditure.

• Pharmaxis Ltd., of Sydney, Australia, began a Phase III trial of Bronchitol in cystic fibrosis patients across Australia, the UK and Ireland to support eventual approval in the European Union, Australia and elsewhere. The study includes a 26-week efficacy treatment period, followed by a 26-week safety extension period. The efficacy component is a randomized, double-blinded investigation of the inhalable dry powder formulation of mannitol twice daily in about 250 patients who will be assessed for improvements in lung function, infectious episodes and quality of life.

• Rigel Pharmaceuticals Inc., of South San Francisco, provided an update on three Phase II trials with oral syk kinase inhibitor R788. The company is expanding a Phase II trial in immune thrombocytopenic purpura (ITP) based on encouraging preliminary drug activity and expects data by the end of the year. Additionally, Rigel is adding trial sites to a Phase II rheumatoid arthritis (RA) trial, in which R788 was well-tolerated at the first of three doses, and expects data in the second half of the year. The company also began enrolling patients in an open-label Phase II B-cell lymphoma trial, which should be completed in 2008.

• Senetek plc., of Napa, Calif., has initiated trials of its Pyratine 6 compound (PRK 124) for acne rosacea after evaluating positive results from a comparison of separate clinical studies of Pyratine 6 and Kinetin, Senetek's original anti-aging active ingredient. The studies found 42 percent and 62 percent reductions in erythema (redness) after two and four weeks respectively, and a 45 percent reduction in acne lesions after 12 weeks. Pyratine 6 was well tolerated by all subjects, producing no measurable skin irritation or signs of allergic contact dermatitis with twice-daily application over the 12-week study period. The trial will be conducted at the University of California at Irvine. The comparative analysis results also have influenced one of Senetek's prospective licensees, a major cosmetic company, to commence separate clinical trials of Pyratine 6 for acne rosacea and skin whitening.

• Valeant Pharmaceuticals International, of Aliso Viejo, Calif., has published Phase II data for retigabine, a first-in-class neuronal potassium channel opener, in Neurology. The authors concluded that retigabine was efficacious with a demonstrated reduction in monthly seizure rates in the study. Two Phase III trials currently are under way to further investigate the efficacy and safety of retigabine as an adjunctive treatment for partial-onset seizures in patients with refractory epilepsy.