• Advanced BioHealing Inc., of New York, said it enrolled the first patient in its initial Celaderm pilot study. The primary goal is to evaluate the safety of Celaderm, a next-generation bioengineered tissue product. The study also will assess the potential for Celaderm to accelerate healing of venous leg ulcers compared with optimal standard therapy. The study is designed to enroll 55 patients.

• Amarillo Biosciences Inc., of Amarillo, Texas, said it began enrolling patients in a Phase II trial testing low-dose interferon-alpha lozenges in HIV-positive subjects with oral warts. The study will enroll 80 patients, who will undergo 24 weeks of treatment.

• Arpida Ltd., of Basel, Switzerland, said results of a Phase I trial confirmed that intravenous iclaprim was safe and well tolerated in volunteers with varying degrees of renal and hepatic impairment and obesity. Also, predictable pharmacokinetics were observed in those populations, suggesting that monitoring might not be required. The 68-subject trial was designed to support filing for intravenous iclaprim, a broad-spectrum antibiotic that is in Phase III trials in complicated skin and skin structure infections.

• Centocor Inc., of Horsham, Pa., said Phase II data showed that patients with moderate to severe plaque psoriasis receiving subcutaneous injections of CNTO 1275 (IL-12/23 mAb) experienced significant clearance of skin disease and significant improvements in quality of life. At week 12, 81 percent of patients receiving four weekly 90-mg doses of the drug achieved at least 75 percent improvement in their psoriasis, as measured by the Psoriasis Area Severity Index, compared to 2 percent of patients receiving placebo. Those results were published in the New England Journal of Medicine.

• Cytogen Corp., of Princeton, N.J., said seven-year survival data suggested Prostascint might help predict which patients are less likely to benefit from brachytherapy for prostate cancer. The study evaluated Prostascint fusion imaging to define brachytherapy treatment regimens for 239 newly diagnosed patients, and results showed that the cure rate was 90.6 percent for patients whose fused Prostascint scan showed local disease versus 66.1 percent for patients with distant disease. Data were published in the on-line edition of Brachytherapy. Prostascint is a monoclonal antibody-based agent that targets prostate-specific membrane antigen to image the extent and spread of prostate cancer.

• ISTA Pharmaceuticals Inc., of Irvine, Calif., reported statistically significant results from an initial analysis of its Phase III trials of Xibrom (bromfenac sodium ophthalmic solution) once-daily formulation, showing that the product was effective in treating postoperative ocular pain and inflammation associated with cataract surgery. The trial involved 500 patients randomized to receive the once-daily formulation of Xibrom or placebo. Based upon those results, ISTA anticipates filing a supplemental new drug application for the once-daily formulation.

• LAB International Inc., of Montreal, completed patient enrollment in its pilot GHRH Phase IIa study. LAB's proprietary 29 amino-acid peptide analogue of GHRH is designed to stimulate growth hormone secretion in patients. Positive results from the Phase I trial showed that after administration of GHRH, a rapid and significant increase in the levels of growth hormones occurred at all dosage levels; no significant adverse effects were observed. The placebo-controlled Phase II trial is being conducted in three centers in Europe and will investigate the efficacy and safety of GHRH. Safety and efficacy data are expected in May.

• Medivir AB, of Huddinge, Sweden, said Tibotec Pharmaceuticals Ltd., of Mechelen, Belgium, has initiated a Phase I trial with a potent and selective hepatitis C virus (HCV) NS3/4A protease inhibitor for the treatment of chronic hepatitis C virus infection. The companies signed an agreement in November 2004 in which Tibotec licensed the inhibitor to Medivir. The Phase Ia trial is designed to assess the safety, tolerability and pharmacokinetics of the inhibitor in healthy volunteers. The study will be conducted in Europe. The preclinical research conducted on the clinical candidate demonstrated favorable characteristics in potency, cross-resistance profiles and pharmacokinetic properties, supporting the exploration of oral dosing in the clinical trials. This milestone triggers a payment of €2.5 million (US$3.26 million) to Medivir.

• Pfizer Inc., of New York, said the FDA approved new labeling for Sutent (sunitinib malate) to include first-line treatment of advanced renal cell carcinoma. Sutent originally was approved in January 2006 for the treatment of advanced kidney cancer. The drug is a multiple-receptor tyrosine kinase inhibitor.

• The Fred Hutchinson Cancer Research Center, of Seattle, has launched a large-scale study to evaluate a candidate HIV vaccine on the African continent. The test vaccine, known as the MRKAd5 HIV-1 trivalent vaccine, is manufactured by Merck & Co. Inc., of Whitehouse Station, N.J., and has been studied for several years in Phase I and II trials involving thousands of volunteers in the Americas and Australia to evaluate safety and immune responses. The African study will involve up to 3,000 participants at five sites throughout and is expected to last four years. Volunteers will be healthy HIV-negative males and females, 18 to 35, who are sexually active and not pregnant. The Phase IIb efficacy trial will test whether the vaccine prevents HIV infection, results in lower HIV levels in those who become infected after vaccination or both. In addition, investigators for the South Africa vaccine trial will determine if the vaccine, which is based on clade B HIV, has the potential to protect against the clade C virus, the subtype prevalent in South Africa.

• United Therapeutics Corp., of Silver Spring, Md., said its wholly owned subsidiary, Lung Rx Inc., reported results from randomized, controlled pilot studies of treprostinil sodium for inhalation stating that dose increases across a 10-day fold range were effective and well tolerated. Those results were published in the Journal of The American College of Cardiology. Lung Rx also said it submitted the proposed brand name of Viveta for treprostinil to the FDA.

• Zelos Therapeutics Inc., of West Conshohocken, Pa., said top-line results from a Phase II study showed that Ostabolin-C, a parathyroid hormone analogue, met its primary objective by demonstrating a statistically significant, dose response increase in mean lumbar spine bone mineral density that reached 5.2 percent at the highest dose tested. Data stemmed from a four-month study period evaluating Ostabolin-C in 261 postmenopausal women with osteoporosis. Over three-fourths of the study subjects participated in an additional eight-month, blinded extension study, the results of which are expected in the second quarter.