• Avexa Ltd., of Melbourne, Australia, disclosed positive 24-week data from the Phase IIb trial of apricitabine (ATC), showing that, in more than 80 percent of patients treated with the drug, the level of HIV in the blood was reduced to below detectable levels, a result "markedly" better than those patients on the 3TC control. Data suggested that with ATC, drug-resistant patients with multiple previous treatment failures can achieve a response approaching that of previously untreated patients on first-line therapy, the company said.

• Encysive Pharmaceuticals Inc., of Houston, completed patient enrollment in the Phase II trial for Thelin (sitaxsentan) in the treatment of diastolic heart failure (DHF), a type of congestive heart failure. Thelin is being tested in about 150 DHF patients at about 40 study centers. The primary efficacy objective of the study is change in treadmill exercise time at 24 weeks of treatment. A data safety monitoring board has conducted two reviews of the Phase II trial with no recommended changes to the study plan.

• InterMune Inc., of Brisbane, Calif., said the amended Clinical Trial Authorization related to the Phase Ib clinical trial of ITMN-191 (also known as Roche-R7227) has been approved by the appropriate European regulatory authorities, and InterMune has received approval from the ethics committee of the institutions that will conduct the trial. The multiple ascending dose study will begin this month, and Intermune expects to announce initial top-line viral kinetic and safety results from the first three dose cohorts of the trial in the first quarter of 2008. ITMN-191 is an orally available hepatitis C virus protease inhibitor in development by InterMune and its partner, F. Hoffman-La Roche Ltd., of Basel, Switzerland.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., said it has initiated a Phase I study of ISIS 325568, an antisense drug designed to improve blood glucose control in patients with Type II diabetes by inhibiting production of the glucagon receptor, a receptor that binds glucagon, a hormone that opposes the action of insulin. The Phase I trial is designed to assess the drug's activity, including its effect on liver glucose production, as well as safety and pharmacokinetic profiles, providing the opportunity to demonstrate proof of concept in the first human trial. The study is a randomized, placebo-controlled, dose-escalation study conducted in healthy volunteers.

• Ovation Pharmaceuticals Inc., of Deerfield, Ill., initiated a pivotal Phase III trial evaluating clobazam as adjunctive treatment for patients with Lennox-Gastaut syndrome, a severe form of childhood epilepsy that frequently persists into adulthood. Clobazam, approved already outside the U.S., is a 1,5 benzodiazapine with significant anticonvulsant properties. The Phase III study is designed to evaluate the safety and efficacy of clobazam in the reduction of atonic seizures at three dose levels in children and adults with LGS. The double-blind, placebo-controlled study is expected to last up to 23 weeks.

• Poniard Pharmaceuticals Inc., of South San Francisco, said results of a Phase II clinical trial confirm an earlier analysis of data that picoplatin demonstrated a survival benefit in patients with recurrent small-cell-lung cancer who have relapsed within six months of first-line therapy. The company said that the median one-year survival rate was 17.6 percent in the population of mostly platinum-refractory and -resistant patients studied in the trial. Picoplatin currently is being evaluated in the pivotal Phase III trial in platinum-refractory, -resistant and -sensitive SCLC patients who have failed or relapsed from initial therapy within six months of initial treatment and is comparing picoplatin treatment with best supportive care to best supportive care alone.

• The Medicines Co., of Parsippany, N.J., said that results of a Phase III trial known as ACUITY showed that patients with acute coronary syndromes undergoing percutaneous coronary intervention, or angioplasty, experienced nearly 50 percent less bleeding at 30 days and comparable mortality at one year when treated with Angiox (bivalirudin) alone compared to unfractionated heparin or enoxaparin plus a glycoprotein IIb/IIIa inhibitor. Those findings were consistent in patients switched to Angiox monotherapy from unfractionated heparin or enoxaparin.

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