• Amylin Pharmaceuticals Inc., of San Diego, and Eli Lilly and Co., of Indianapolis, presented study results comparing treatment of exenatide injection with insulin glargine on beta-cell function, glycemic control and weight in people with Type II diabetes. Study findings showed one year of Byetta (exenatide) therapy, as compared to insulin glargine, markedly improved different indices of beta-cell function, along with similar glycemic improvement. In addition, patients treated with exenatide lost weight, whereas patients treated with glargine gained weight. The findings were presented at the European Association for the Study of Diabetes meeting in Amsterdam, the Netherlands. Byetta is an incretin mimetic approved by the FDA for use as an add-on therapy in Type II diabetics who are unsuccessful at controlling their blood sugar levels.

• Merck & Co. Inc., of Whitehouse Station, N.J., discontinued a Phase II study of its HIV vaccine, V520, after an independent data safety monitoring board reported that the trial would not meet its efficacy endpoints. Two additional Phase I trials have been discontinued. The vaccine candidate is a mixture of three components, each made with a weakened version of adenovirus Type 5, along with three synthetically produced HIV genes, known as gag, pol and nef. According to the DSMB, the vaccine did not prevent infection, with 24 cases of HIV infection observed in the 741-subject treatment group, compared to 21 cases observed in the 762-subject placebo group.

• NeurogesX Inc., of San Carlos, Calif., said it completed enrollment in study C119, a second Phase III trial of its lead product candidate, NGX-4010, for the treatment of painful HIV-distal sensory polyneuropathy. NGX-4010 is a dermal patch designed to manage peripheral neuropathic pain. C119 is a randomized, double-blind, controlled study that has enrolled more than 480 patients at sites in the U.S., the UK, Australia and Canada. The company said it expects to be able to provide top-line results near the end of the first quarter of 2008. NeurogesX already completed two Phase III studies of NGX-4010 in postherpetic neuralgia and one in HIV-DSP. (See BioWorld Today, June 8, 2007, and Sept. 5, 2007.)

• ThromboGenics NV, of Leuven, Belgium, said it completed patient enrollment in the Phase IIa MIVI IIT trial evaluating the safety and efficacy of microplasmin for treating vitreomacular traction, including macular holes. The controlled study recruited 30 patients in Europe. While the study remains masked, initial data showed microplasmin was well tolerated in both treatment cohorts. Additionally, posterior vitreous detachment induction was observed in a number of patients and in some cases led to the nonsurgical resolution of traction and even macular hole closure with improvement in vision, preventing the need for vitrectomy, the company said.