• Biogen Idec Inc., of Cambridge, Mass., and Fumapharm AG, of Lucerne, Switzerland, reported positive results of a Phase II study of BG-12, an oral fumarate, in patients with relapsing-remitting multiple sclerosis. The study achieved its primary endpoint, demonstrating BG-12 led to a statistically significant reduction in the total number of gadolinium-enhancing brain lesions, as measured by MRI, after six months of treatment vs. placebo. Data were presented at the annul meeting of the European Neurological Society in Lausanne, Switzerland.

• BioInvent International AB, of Lund, Sweden, said results from a Phase I/IIa trial of BI-201 showed the drug was well tolerated but demonstrated no reduction of HIV levels with the investigated dosing. The company plans to amend the study protocol to include more patients on higher doses. It expects to have final results by the end of the year.

• CuraGen Corp., of Branford, Conn., started patient dosing in its second velafermin Phase II study, which is designed to assess the safety and efficacy of 30 mcg/kg of the drug for preventing oral mucositis in cancer patients receiving high-dose chemotherapy, with or without radiotherapy, in the setting of autologous bone marrow transplantation. It will enroll about 400 patients. Data are expected during the third quarter.

• Immutep SA, of Orsay, France, said its lead product, ImmuFact IMP321, completed two large, randomized Phase I studies assessing safety, tolerability and immune response in normal healthy volunteers. The product is a potent natural human T-cell immunostimulatory factor designed to amplify the T-cell immune response in therapeutic vaccines. The randomized, single-blind, escalating-dose Phase I studies were conducted in healthy individuals with ImmuFact IMP321 alone and combined with antigens. Data showed the product is well tolerated with no adverse events at all dose levels either alone or associated with potent antigens. There were no anti-IMP321 antibodies detected.

• Ista Pharmaceuticals Inc., of Irvine, Calif., began two randomized, double-blind, placebo-controlled multicenter Phase III trials of a new once-daily formulation of Xibrom (bromfenac ophthalmic solution) for pain and inflammation following cataract surgery. Twice-daily Xibrom is approved to treat ocular inflammation and reduction of ocular pain following cataract surgery. The Phase III trials are expected to enroll about 350 patients. They should be concluded in the fourth quarter, and the filing of a supplemental new drug application for the once-daily formulation is expected in 2007.

• NeoPharm Inc., of Waukegan, Ill., said enrollment of 54 patients began for a multicenter Phase II trial of LE-SN38 to treat patients with metastatic colorectal cancer. The trial is being conducted by Cancer and Leukemia Group B, an oncology clinical research group sponsored by the National Cancer Institute. LE-SN38 is the company's NeoLipid liposomal formulation of SN-38, the active metabolite of irinotecan (Camptosar), a chemotherapeutic pro-drug approved to treat advanced colorectal cancer.

• Samaritan Pharmaceuticals Inc., of Las Vegas, reported preliminary results showing antiviral activity in 10 days with its Phase II monotherapy study of SP-01A, an oral entry inhibitor, in HIV patients experiencing drug resistance. SP-01A was found to have a 0.4 log10 difference between the high-dose group (800 mg/day) and the placebo control group, and data showed a dose-dependent relationship in the number of patients who had a reduction in viral load, with 55 percent in the 800 mg/day group and 0 percent in the placebo group. Samaritan's stock (AMEX:LIV) climbed 14 percent on the results, closing at 48 cents, up 6 cents.