• Actelion Pharmaceuticals Inc., of Chicago, said results from two trials demonstrated that Tracleer, when given in combination with Viagra (sildenafil), is well tolerated and improves hemodynamics in patients with pulmonary arterial hypertension. The COMPASS-1 (effects of combination of bosentan and sildenafil vs. sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension) trial was the first study to provide detailed hemodynamic information on the combination of Tracleer and sildenafil and showed that the combination of acute oral sildenafil together with long-term Tracleer therapy significantly reduced pulmonary vascular resistance.

• ActivBiotics Inc., of Lexington, Mass., said it completed enrollment for a Phase II study to evaluate the effect of rifalazil, an antichlamydial antibiotic, on the progression of carotid artery atherosclerosis. The trial is a prospective, randomized, double-blind, placebo-controlled, multicenter study of 72 patients with a clinical history of atherosclerosis and image-detectable carotid disease. The study will use the noninvasive imaging techniques of combined high-resolution magnetic resonance imaging and ultrasound to assess the degree of architectural changes in the carotid artery brought about by rifalazil treatment.

• AngioChem, of Montreal, received FDA clearance to move its lead drug candidate, ANG1005, into Phase I/II development targeting primary (glioblastoma) and metastatic brain tumors. ANG1005 consists of a vector that transports drugs across the blood-brain barrier conjugated to three molecules of paclitaxel. The company aims to start two parallel studies involving about 30 patients each, with one study focused on recurrent glioblastoma patients and the second study treating patients with brain metastasis. The primary endpoint of both trials is safety, tolerability and determination of the maximum tolerated dose.

• Anthera Pharmaceuticals Inc., of San Mateo, Calif., said results of a Phase II clinical trial of A-002 suggested the compound resulted in significant reductions in blood levels of total cholesterol, non-high density lipoprotein cholesterol and low density lipoprotein cholesterol, coupled with equally meaningful reductions of C-reactive protein, a recognized marker of inflammation and cardiovascular risk. Decreases in those levels were most significant among patients already on a background of statin therapy. The trial was a multicenter, randomized, double-blind, placebo-controlled trial that enrolled approximately 400 patients with stable coronary heart disease in the U.S. and Ukraine. The primary endpoint, a reduction in secretory phospholipase A2 levels, was achieved with a high degree of statistical significance, the firm said. The results also demonstrated clinically meaningful and statistically significant decreases in cholesterol levels in patients with stable coronary heart disease. Clinically meaningful decreases in inflammation also were observed.

• Gilead Sciences Inc., of Foster City, Calif., reported that new long-term data from the Phase III ARIES studies evaluating ambrisentan in patients with pulmonary arterial hypertension (PAH) showed that 95 percent of patients were still alive at one year of treatment. Ambrisentan, an endothelin receptor antagonist that recently received accelerated approval by the FDA, is indicated as a once-daily treatment for PAH. Results showed that there were consistent trends in increased exercise capacity, decreased dyspnea and less World Health Organization functional class deterioration in patients taking ambrisentan compared with those taking placebo.

• Inhibitex Inc., of Alpharetta, Ga., initiated a Phase I trial of its orally bioavailable nucleoside analogue FV-100 for the treatment of shingles. Shingles is a possible consequence of infection with varicella zoster virus, the same virus that causes chicken pox. The single ascending dose study will evaluate the safety and pharmacokinetics of three doses of FV-100 in 24 healthy volunteers.

• Marillion Pharmaceuticals Inc., of Malvern, Pa., said it has received approval from the FDA for a Phase I study of MN-201, an orally administered vitamin D5 analogue for the treatment of cancer. The Phase I trial will be an open-label, dose-escalation study to evaluate the safety and pharmacology of MN-201 in patients with advanced tumors in various cancers. In preclinical studies, MN-201 demonstrated broad antitumor activity in cancer cells. In animal models, oral administration of MN-201 also resulted in antitumor activity including tumor regression in xenograft models of major solid tumor types.

• Omrix Biopharmaceuticals Inc., of New York, said it has initiated enrollment in a Phase I/II clinical trial for Adhexil, its adhesion prevention product. The study will evaluate the safety and initial efficacy of Adhexil in preventing and/or reducing postoperative adhesions in patients undergoing gynecological surgery of the ovaries. Such adhesions are an adverse consequence of surgery that results from the self-repair of tissue. The trial will enroll 25 patients in Europe and the U.S.

• Oncolytics Biotech Inc., of Calgary, Canada, said it has received approval from the UK Medicines and Healthcare Products Regulatory Agency to begin a clinical trial using intravenous administration of Reolysin, the firm's proprietary formulation of the human reovirus, in combination with cyclophosphamide, a chemotherapeutic agent and immune modulator, in patients with advanced cancers. The trial is an open-label, dose-escalating, nonrandomized study of Reolysin given intravenously with escalating doses of cyclophosphamide. The primary objectives include determining the minimum effective immunomodulatory dose of cyclophosphamide to obtain successful immune modulation. Secondary objectives include the safety profile of the combination and gathering any evidence of antitumor activity.

• The Medicines Co., of Parsippany N.J., said its investigational antihypertensive drug Cleviprex (clevidipine butyrate injectable emulsion) rapidly reduced blood pressure and maintained blood pressure control in patients presenting to the emergency department with acute hypertension. Patients infused with Cleviprex, reached target blood pressure levels by a median of 10.9 minutes, and 92 percent of patients who received 18 hours of continuous Cleviprex therapy did not require additional I.V. antihypertensive agents. The data from a Phase III trial were presented at the annual meeting of the American College of Chest Physicians in Chicago.

• Vermillion Inc., of Fremont, Calif., announced that it has completed clinical trial enrollment for its ovarian cancer triage test; 550 patients were enrolled at 27 clinical trial sites. The goal of the prospective trial is to demonstrate that the ovarian triage test can help distinguish benign from malignant ovarian tumors.