• Active Biotech AB, of Lund, Sweden, reported data from an interim analysis of the ongoing TASQ Phase I study showing that daily treatment of 0.5 mg TASQ led to a reduced rate of prostate specific antigen (PSA) in all 10 patients with hormone-refractory prostate cancer. In nine of the 10 patients, that decrease was greater than 50 percent, and four patients showed a decrease serum level of PSA after four months of TASQ treatment. The trial is expected to involve a total of 24 patients. Active Biotech anticipates starting Phase II/III studies next year.

• Avidia Inc., of Mountain View, Calif., initiated dosing in a Phase I trial of C326, an inhibitor of interleukin-6, in Crohn's disease. The trial is being conducted in Australia and will evaluate the safety, tolerability and pharmacokinetics of C326 vs. placebo in adult patients. C326, an Avimer protein, is Avidia's first product to enter clinical development.

• ChemGenex Pharmaceuticals Ltd., of Melbourne, Australia, began a Phase II/III study of Ceflatonin (homoharringtonine, HHT) in patients with chronic, accelerated and blast-phase chronic myeloid leukemia who have the T315l bcr-abl point mutation. That mutation is associated with resistance to Gleevec and other tyrosine kinase inhibitors. The study is expected to enroll up to 81 patients by mid-2007, and the primary endpoint for the trial will be hematologic response rate. The secondary endpoint will be cytogenetic response rate. Ceflatonin is designed to induce apoptosis in myeloid cells and to inhibit angiogenesis.

• EPIX Pharmaceuticals Inc., of Lexington, Mass., said the Australian Therapeutic Goods Administration approved its blood pool imaging agent, Vasovist, which is indicated for contrast-enhanced magnetic resonance angiography for visualization of vascular disease in abdominal or limb vessels. To date, the product has been approved in 27 countries. In the U.S., Vasovist has received two approvable letters, and the FDA suggested in an August letter that additional trials be conducted.

• Genfit SA, of Lille, France, entered Phase I testing of GFT505, its molecule for the simultaneous treatment of several risk factors of cardiometabolic disease. The first study will evaluate the drug in healthy volunteers, and results are expected in the first half of 2007. GFT505 is a multimodal, pluripotent compound designed to act on the molecular level by activating peroxisome proliferator-activated receptors (PPAR), which play a role in the regulation of lipid metabolism and glycemic control.

• Pozen Inc., of Chapel Hill, N.C., and GlaxoSmithKline plc, of London, reported that new data from more than 1,100 patients demonstrated that Trexima delivered consistent efficacy over multiple migraine attacks. In one study, 570 patients treated 1,693 attacks with Trexima and treated 424 attacks with placebo. About 52 percent of patients were pain-free two hours after receiving Trexima vs. 25 percent with placebo. Findings were presented at the 16th Migraine Trust International Symposium in London. Trexima, the proposed brand name for a single tablet containing sumatriptan 85 mg, formulated with RT Technology, and naproxen sodium 500 mg, is under review at the FDA for the acute treatment of migraines in adults.

• Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., and Wyeth Pharmaceuticals, a division of Madison, N.J.-based Wyeth, initiated the first of two pivotal Phase III trials of intravenous methylnaltrexone in postoperative ileus. The double-blind, randomized, placebo-controlled study will enroll about 500 patients who have undergone segmental colectomy surgery to receive one of two dose levels of methylnaltrexone or placebo following surgery and every six hours until either the patient recovers gastrointestinal function or 10 days. Duration of postoperative ileus, as measured by time to first bowel movement, will be the primary endpoint. The study also will evaluate safety and other secondary measures of gastrointestinal recovery, such as time to discharge eligibility. Progenics expects to begin a second Phase III trial later this year, and pending results of both studies, anticipates filing a new drug application in late 2007 or early 2008. Methylnaltrexone has fast-track designation from the FDA.

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