• Alimera Sciences, of Atlanta, and pSivida Ltd., of Perth, Australia, said they have started enrollment for the first human pharmacokinetic study of fluocinolone acetonide in Medidur, an investigational product for the treatment of diabetic macular edema. Medidur is a tiny insert, injected intravitreally during an in-office procedure, which is being studied as a way to deliver a very-low dose of fluocinolone acetonide, a corticosteroid, to the retina for up to three years as a treatment for DME. Alimera and pSivida have a worldwide agreement to co-develop and market the Medidur insert for the use of FA to treat DME.

• Antisoma plc, of London, said results from a single-arm Phase II trial of ASA404 in non-small-cell lung cancer undergoing chemotherapy supported earlier data that showed one of the largest increases in median survival data reported in patients with the condition. In the earlier trial, the median survival was 14 months in patients who received a 1,200 mg/m2 dose of ASA404 combined with chemotherapy and of 8.8 months in patients who received chemotherapy alone. Patients in the recent trials received 1,800 mg/m2 dose of ASA404 in combination with chemotherapy.

• Kiadis Pharma BV, of Groningen, the Netherlands, enrolled the last patient in its Phase I/II trial of Rhitol in steroid-resistant or intolerant chronic graft-vs.-host disease following bone marrow transplantation. A total of 20 patients were randomized to receive either low or high doses of Rhitol, a small-molecule drug designed to selectively accumulate in reactive immune cells and to eliminate those cells upon photo-activation. So far, 10 patients have completed the six-month treatment period, and the company reported no treatment-related toxicities so far. An end-of-enrollment survey also indicated that Rhitol treatment was beneficial to about 90 percent of the patients who completed therapy. Final results from the study are expected in early 2008.

• Medicure Inc., of Winnipeg, Manitoba, said it has received another recommendation from its data safety monitoring board to continue its Phase III trial examining its cardioprotective agent MC-1 in patients undergoing coronary artery bypass graft (CABG) surgery. The firm expects to complete enrollment of the 3,000-patient study, known as MEND-CABG II, by late September.

• QuatRx Pharmaceuticals, of Ann Arbor, Mich., said that it has completed enrollment of a pivotal Phase II clinical trial of Ophena (ospemifene), an estrogen-free oral therapy in development for the treatment of postmenopausal vaginal syndrome. Enrollment reached 827 postmenopausal women at 80 U.S. trial centers. Women participating in the study are treated with either a 30-mg or 60-mg once-daily oral dose of Ophena or placebo for 12 weeks. Phase II trials of Ophena demonstrated beneficial effects on vaginal epithelium and bone markers, the firm said.

• ViaCell, Inc., of Cambridge, Mass., said it expects to expand the number of U.S. clinical sites participating in its ViaCyte pivotal trial from three to eight. ViaCyte is an investigational product intended to broaden reproductive options for women through the freezing and thawing of human oocytes. The FDA has approved ViaCell's Investigational Device Exemption supplement supporting the expansion of its U.S. clinical trial sites. The pivotal trial commenced in March and is expected to be completed in 2009.

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