• Antisoma plc, of London, started a Phase IIb trial of AS1411, a nucleolin-targeted aptamer drug, in patients with acute myeloid leukemia. The study is expected to enroll about 90 patients with AML who are in first relapse or are refractory to one prior treatment to receive either AS1411 with high-dose cytarabine or cytarabine alone. Safety, response rates, period free of leukemia and survival will be assessed. Data are anticipated next year.

• CPEX Pharmaceuticals Inc., of Exeter, N.H., reported preliminary results from its Phase IIa trial of nasal insulin product Nasulin, showing that subjects treated with Nasulin did not demonstrate statistically significant increase from baseline in the mean proportion of time spent with normal glucose levels compared to those receiving placebo, as assessed by continuous glucose monitoring over a six-week treatment period. The study enrolled 94 patients. CPEX said it intends to conduct additional analyses to determine the next steps for the Nasulin program and, in the interim, will not start a Phase IIb study as previously planned.

• MediciNova Inc., of San Diego, reported preliminary results from its Phase Ib trial of MN-221, a selective beta(2)-adrenergic receptor agonist, in patients with stable, moderate to severe chronic obstructive pulmonary disease, which showed clinically significant improvements in percent change in forced expiratory volume in one second. The study enrolled 48 patients who received a one-hour intravenous infusion of MN-221 at three different escalating dose levels or placebo. FEV(1) increased as compared to baseline by an average of 21.5 percent for the 1,200 mcg dose, 16.2 percent for the 600 mcg dose and 9.2 percent for the 300 mcg dose compared to a decrease of 4 percent for the placebo group. The drug was well tolerated.

• Novelos Therapeutics Inc., of Newton, Mass., is dropping work on NOV-002, a small-molecule formulation of oxidized glutathione, in non-small-cell lung cancer after the drug failed to meet primary or secondary endpoints in combination with paclitaxel in a pivotal study. Novelos reported disappointing Phase III data last month, which sent shares down 80 percent. The company continues to test the drug in a Phase II breast cancer study, with results expected in the third quarter. (See BioWorld Today, Feb. 25, 2010.)

• PolyMedix Inc., of Radnor, Pa., began a Phase Ib study to evaluate the safety and efficacy of PMX-60056 in reversing the anticoagulant activity of low molecule weight heparin. The double-blind, crossover study will be conducted at a single site in the U.S. Up to six healthy subjects will be randomized into two cohorts. All subjects will receive tinzaparin followed by two 10-minute infusions of either PMX-60056 or placebo.