• Arena Pharmaceuticals Inc., of San Diego, said treatment with APD125 in patients with primary insomnia in a Phase IIb trial was well tolerated, and there were no reports of serious adverse events and no emerging safety findings as compared to placebo. However, the preliminary data indicated that APD125 did not meet the trial's primary or secondary endpoints. Completion of data analysis is continuing, but Arena does not anticipate any further development of APD125. Shares of Arena (NASDAQ:ARNA) gained 9 cents to close at $3.71 Wednesday.

• Capstone Therapeutics, of Tempe, Ariz., announced positive safety results from the second of two planned Phase I trials of AZX100 in dermal/hypertrophic scarring. No serious treatment-emergent adverse events were reported, and secondary outcomes indicated a statistically significant signal of pharmacological effect in favor of AZX100. The company said it plans to launch a Phase II trial in the first quarter of 2009.

• Nuvelo Inc., of San Carlos, Calif., reported positive results from the Phase I trial of NU206 (R-spondin1), a recombinant, secreted protein that acts as a key regulator of the Wnt pathway. Data from the placebo-controlled, single-ascending dose trial of a single intravenous administration of NU206 in 32 healthy male volunteers showed that the compound had a favorable safety profile, no serious adverse events were observed and pharmacokinetics were predictable.

• PolyMedix Inc., of Radnor, Pa., said it completed its Phase I safety study with its antibiotic drug candidate PMX-30063, a small-molecule mimetic of host defense protein. The data from the study demonstrated that a single dose of the drug was safe and well tolerated. Further clinical development will continue for the initial indication as a treatment for pan-Staphylococcal infections.

• Proteo Inc., of Irvine, Calif., and its wholly owned subsidiary Proteo Biotech AG, of Kiel, Germany, with Minapharm Pharmaceuticals SAE and its subsidiary Rhein Minapharm Biogenetics SAE, of Cairo, Egypt, said Cairo authorities granted approval for a Phase II trial to study the efficacy of Elafin for prevention of acute and chronic allograft nephropathy on kidney transplant patients.

• Seattle Genetics Inc., of Bothell, Wash., said an independent data monitoring committee completed a prespecified safety review of data from the ongoing Phase IIb trial of lintuzumab (SGN-33) in combination with low-dose cytarabine chemotherapy for older patients with acute myeloid leukemia (AML), and did not identify any safety concerns and has recommended that the trial continue per the protocol. The company has completed approximately two-thirds of the total target enrollment of 210 patients, and expects to report data in the first half of 2010.

• UCB SA, of Brussels, Belgium, reported findings from new studies of the once-daily antiepileptic drug Keppra XRTM (levetiracetam) extended-release tablets comparing tolerability vs. levetiracetam immediate release (IR) and reporting on additional dosing schedules. According to the meta analysis of a Phase III data, patients taking Keppra XR once-daily had lower rates of some adverse events vs. levetiracetam IR twice-daily. Keppra XR was approved by the FDA in September for use as adjunctive treatment for people with partial-onset seizures who are 16 years of age and older. The data were among five studies that were presented at the 62nd annual meeting of the American Epilepsy Society in Seattle.

• XOMA Ltd., of Berkeley, Calif., said it accelerated its plans to initiate a Phase II trial of XOMA 052, a monoclonal antibody binding to interleukin-1 beta, for the treatment of Type II diabetes, in the second quarter of 2009. The decision is based on ongoing Phase I results in humans with Type II diabetes and on new preclinical findings. The preclinical results indicated that animals treated with XOMA 052 have increased insulin production and proliferation of insulin-producing islet cells. They also show decreased islet cell death, reduced peripheral insulin resistance and lower cholesterol levels. There was an absence of weight gain and hypoglycemic events.