• Achillion Pharmaceuticals Inc., of New Haven, Conn., said preliminary 12-week data from an ongoing Phase II trial of elvucitabine in patients infected with wild-type HIV showed an antiviral activity similar to 3TC (lamivudine), with a mean change in HIV-RNA from baseline in the elvucitabine group of -2.7log10 vs. -3log10 in the 3TC group. Achillion's drug also was well tolerated, with no serious drug-related adverse events. Elvucitabine is an L-cytosine nucleoside analogue reverse transcriptase inhibitor. Further results from the study will be presented at a future scientific conference.

• Alimera Sciences Inc., of Atlanta, said an independent data safety monitoring board reviewed data available from the company's pivotal Phase III FAME (Fluocinolone Acetonide in Diabetic Macular Edema) study of Medidur FA and recommended that the study continue under the current protocol without change. The FAME trial is following more than 900 patients for 36 months in support of a planned global registration filing, with safety and efficacy assessed after two years of follow-up. Alimera and partner, pSivida Ltd., of Perth, Australia, reported last week that enrollment for the FAME study is complete. Medidur, a tiny, injectable insert, is in development as a way to deliver the corticosteroid fluocinolone acetonide to the retina for up to three years to treat DME.

• Cutanea Life Sciences, of Malvern, Pa., announced results from its completed Phase II clinical trial of Omiganan. The trial compared Omiganan 2.5 percent and 1 percent topical gel to vehicle in subjects with papulopustular rosacea. Study results showed the formulation was safe and well tolerated at all doses tested. Among the once-daily treatment arms, a dose-dependent response was observed in both lesion reductions and treatment success, as defined by Investigator Global Assessment scores. After nine weeks of treatment, once-daily Omiganan 2.5 percent gel showed superior lesion count reductions and treatment success compared to 1 percent Omiganan QD and vehicle. Omiganan also provided greater improvements compared to vehicle among patients with a more numerous inflammatory lesions.

• Genta Inc., of Berkeley Heights, N.J., said the French Health Products Safety Agency has granted authorization to open a Phase III trial of Genasense (oblimersen sodium) Injection, its lead anticancer compound, in patients with advanced melanoma. That allows the opening of approximately 13 new investigative sites over the next two to four weeks. The trial, known as AGENDA, is a randomized, double-blind, placebo-controlled study in which patients are randomly assigned to receive Genasense plus dacarbazine (DTIC) or DTIC alone. AGENDA will accrue approximately 300 patients and will be conducted at approximately 100 sites worldwide. Accrual, which is currently ongoing, currently is expected to complete in the fourth quarter of 2008.

• GlaxoSmithKline Biologicals, of Rixensart, Belgium, reported that Phase II study results of its investigational malaria vaccine RTS,S/AS02 in infants showed that the product was safe and reduced malaria parasite infection and clinical illness due to malaria. The vaccine had a 65 percent efficacy rate against new infections over a three-month follow-up period after the infants received all three doses of the vaccine. The results also showed that the vaccine reduced episodes of clinical malaria by 35 percent over a six-month follow-up period starting after the first dose. The trial was conducted by the Manhiça Health Research Centre in Mozambique, Africa.

• ImmunoGen Inc., of Cambridge, Mass., said Sanofi-Aventis, of Paris, has advanced the TAP compound SAR3419 into Phase I clinical testing. That triggers a $1 million milestone payment to ImmunoGen. SAR3419 is a potential new treatment for non-Hodgkin's lymphoma and other B-cell malignancies, and was created by ImmunoGen and licensed to Sanofi-Aventis as part of a broader collaboration between the companies. For each compound in the collaboration, ImmunoGen is entitled to milestone payments that potentially could total $21.5 million to $30 million, plus royalties on sales.

• Innocoll Inc., of Ashburn, Va., said its wholly owned subsidiary, Innocoll Technologies Ltd., filed an investigational new drug application for CollaRx Bupivacaine Topical, to conduct a Phase II trial in chronic skin ulcers. The product is a biodegradable and fully resorbable Bupivacaine Collagen Sponge formulated using Innocoll's CollaRx technology, which already is in Phase II development for managing postoperative surgical wound pain.

• Omrix Biopharmaceuticals Inc., of New York, reported that results of its prospective, open-label, Phase I study of its novel Fibrin Patch demonstrated that the product was safe as an adjunct to hemostasis. The patch, developed with Ethicon Inc., of Somerville, N.J., contains biologics, which form an instant clot when they come in contact with blood. The study was conducted in Israel and enrolled 10 patients undergoing elective partial nephrectomy. The Fibrin Patch was used in the study as an adjunct to hemostasis after attempts to control bleeding with conventional surgical techniques had been made. Patients were followed up for eight weeks postoperatively.

• Orexigen Therapeutics Inc., of San Diego, has initiated its third of four Phase III clinical trials for its lead product candidate Contrave in obesity. The trial is a 58-week study to assess the safety, tolerability and efficacy of Contrave in healthy, nondiabetic, obese patients. The trial is being conducted in 40 U.S. centers with 1,650 patients. Orexigen initiated enrollment in its first Phase III clinical trial in April and the second trial in May.

• Theravance Inc., of South San Francisco, presented Phase II results of its investigational compound TD-5108. The double-blind, randomized, placebo-controlled, parallel-group, multicenter study involved 401 patients with chronic constipation who were treated for four weeks with one of three doses of TD-5108 (15, 30 or 50 mg) or placebo. The results showed clinical activity for all doses studied; a statistically significant increase in average weekly spontaneous bowel movement (SBM) frequency over the four-week treatment period (the primary endpoint). The average SBM change per week was 3.6 SBM for patients treated with TD-5108 15 mg compared to 1.4 for placebo; and a statistically significant increase in average weekly complete SBM frequency of 2.3 SBM for patients treated with TD-5108 15 mg compared with 0.6 for placebo. The data were presented at the American College of Gastroenterology Annual Scientific Meeting in Philadelphia.

• Vical Inc., of San Diego, said an independent data safety monitoring board (DSMB) found no safety issues and recommended continuation of the company's Phase II trial of a DNA vaccine against cytomegalovirus (CMV). The DSMB completed an interim evaluation of safety data after the two-month follow-up visits for the first 20 hematopoietic stem cell transplant recipients enrolled in the study. Because most HCT recipients are expected to face a natural viral challenge as pre-existing CMV infection reactivates under immunosuppression, the primary efficacy endpoint in the double-blind, placebo-controlled trial is the occurrence rate of clinically significant CMV levels in HCT patients receiving vaccine compared with patients receiving placebo.