• BioDelivery Sciences International Inc., of Morrisville, N.C., said a pharmacokinetic study of BEMA Fentanyl demonstrated that both peak plasma fentanyl concentrations and overall exposure increase in a linear manner across the range of BEMA Fentanyl doses tested, signaling dose proportionality. The study was performed in healthy subjects receiving three different doses of the product. The company is conducting a Phase III program of BEMA Fentanyl, which is expected to wrap up by the end of 2006.

• Immunomedics Inc., of Morris Plains, N.J., said results from a 14-patient Phase II study of epratuzumab in systemic lupus erythematosus found that 77 percent of patients had a decrease in BILAG (British Isles Lupus Assessment Group) scores by 50 percent or more at six weeks of follow-up. Ninety-two percent of those had decreases of various amounts continuing to at least 18 weeks. Three patients with multiple BILAG involvement at baseline had completely resolved all B-level disease activities by 18 weeks. The data were published in Arthritis Research & Therapy.

• Jerini AG, of Berlin, randomized the last patient in its Phase III trial of Icatibant, a synthetic peptidomimetic, for hereditary angiodema. A total of 56 patients were treated at 26 sites in the double-blind, placebo-controlled study. Jerini expects to complete randomization for a second Phase III study shortly, with top-line results from both trials available in the third quarter.

• NeoPharm Inc., of Waukegan, Ill., said cintredekin besudotox (IL13-PE38QQR) continues to show evidence of prolonged overall survival in patients with recurrent glioblastoma multiforme, with 45 patients treated in a Phase I/II intraparenchymal setting showing an overall median survival of 44 weeks and an increase to 53.6 weeks for 26 patients with two or more optimally placed catheters. The results were presented at the 7th annual meeting of the American Association of Neurological Surgeons in San Francisco. Cintredekin besudotox is being tested in an ongoing pivotal Phase III trial.

• Novelos Therapeutics Inc., of Newton, Mass., said the FDA accepted its investigational new drug application to begin clinical studies with NOV-205, a compound designed to act as a hepatoprotective agent with immunomodulating and anti-inflammatory properties. An initial Phase Ib trial to test NOV-205 as a monotherapy in patients with chronic hepatitis C genotype 1 who have failed pegylated interferon plus ribavirin therapy is expected to begin by July.

• Zeltia Group, of Madrid, Spain, said its Neuropharma subsidiary started clinical trials of NP031112, its first molecule for Alzheimer's disease. The Phase I trial will consist of two stages, with the first focused on administrating NP031112 in escalating single doses, and the second stage as a repeated dose for seven days. NP031112 is a GSK3 inhibitor.