• ActivBiotics Inc., of Lexington, Mass., has begun patient enrollment in a Phase II study of an anti-chlamydial antibiotic, rifalazil, on atherosclerotic changes in the carotid artery. The prospective, randomized, double-blind, placebo-controlled multicenter study will treat patients with a history of atherosclerotic disease. They will receive weekly treatments of rifalazil or placebo during a 12-week period and will be followed for 18 months with serial magnetic resonance imaging and ultrasound of the carotid artery. Also, ActivBiotics completed enrollment of 296 patients in a Phase III study of the drug for intermittent claudication, a common form of peripheral arterial disease. PROVIDENCE-1 (Prospective Evaluation of Rifalazil Effect on Vascular Symptoms of Intermittent Claudication and Other Endpoints in Chlamydia Seropositive Patients) is a multinational, double-blind, randomized, placebo-controlled trial.

• Elite Pharmaceuticals Inc., of Northvale, N.J., said it has successfully completed the first stage of a Phase II study of ELI-216, with results demonstrating its euphoria-blocking effect. The study was to determine the optimal ratio of oxycodone hydrochloride and opioid antagonist, naltrexone hydrochloride, to significantly block the euphoric effect of the opioid if the product is abused. Without the abuse deterrent, subjects dosed with crushed oxycodone hydrochloride 40 mg extended-release capsules reported a high level of euphoria during the first three hours, with an average peak of 71 on the euphoria scale. ELI-216 crushed showed levels of euphoria of less than 10 on the scale. The next step will be a double-blind, cross-over pivotal study that should begin by the end of this quarter.

• Halozyme Therapeutics, of San Diego, and Baxter Healthcare, of Deerfield, Ill, said results of a Phase IIIb clinical trial showed positive results for the subcutaneous administration of morphine with Hylenex recombinant. Those results showed an acceleration in the time to maximal blood levels of morphine by 33 percent versus morphine with placebo, and appeared safe and well tolerated. Hylenex recombinant is a liquid injectable formulation that includes recombinant human hyaluronidase. The results of the tests of 12 hospice and palliative care patients were to be presented this week at the American Academy of Hospice and Palliative Medicine's annual assembly in Salt Lake City.

• Kamada Ltd., of Ness Ziona, Israel, has submitted plans to the European Agency for the Evaluation of Medicinal Products (EMEA) for a Phase II-III clinical trial of the aerosol formulation of Alpha-1 Antitrypsin for inborn deficiency of Alpha-1 proteinase inhibitor, which may lead to emphysema. The drug has received orphan drug designation from the EMEA and the FDA.

• MedImmune Inc., of Gaithersburg, Md., said pivotal Phase III research showed that children younger than 5 who were immunized with FluMist (influenza virus vaccine live, intranasal) reported 55 percent fewer cases of flu compared to children who received the flu shot. FluMist also demonstrated protection against influenza strains that were both matched and mismatched to the vaccine. Results of the study, which involved 8,475 children, were published in The New England Journal of Medicine. The study, which was conducted during the 2004-2005 flu season, is the basis of a pending FDA application to expand the age indication for FluMist to include children as young as 1 year who do not have a history of wheezing or asthma. FluMist previously was approved for healthy children and adolescents ages 5 to 17 and for healthy adults ages 18 to 49. In separate news, billionaire investor Carl Icahn disclosed new holdings in MedImmune of 2.8 million shares. The company's stock (NASDAQ:MEDI) gained $1.91 Thursday to close at $33.16.

• NanoBio Corp., of Ann Arbor, Mich., started enrolling patients in its Phase IIb study of NB-001, a topical drug candidate for herpes labialis. The trial is expected to recruit about 1,000 subjects. Previous studies of NB-001 showed that a substantially higher proportion of patients receiving the drug healed within three or four days compared to placebo.

• OxiGene Inc., of Waltham, Mass., reported positive results from its Phase II trial of Combretastatin A4 Phosphate (CA4P) in myopic macular degeneration. The study met its primary efficacy endpoint of maintenance of visual acuity (defined as less than a three-line loss in visual acuity at three months) in 100 percent of the patients, and safety results were favorable with no drug-related serious adverse events reported. The company also said it completed a pre-IND meeting with the FDA regarding two topical ophthalmic formulations for CA4P in age-related macular degeneration and intends to proceed with further development of those formulations.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., reported positive results from a Phase Ib trial for bavituximab in chronic hepatitis C virus (HCV) infection. The repeat-dose, multicenter, open label study assessed the safety, distribution and pharmacokinetic properties of four ascending dose levels of the drug administered twice-weekly, and results indicated it generally was safe and well tolerated. They also showed dose-dependent antiviral activity, with 83 percent of patients at the 3 mg/kg dose level showing at least a 75 percent (0.6 log) reduction or better in HCV RNA levels and an average of an 84 percent (0.8 log) reduction for the entire cohort. In that cohort, 50 percent of the patients showed signs of greater antiviral activity, with an average HCV RNA load reduction of 1 log. Patients showing signs of antiviral activity typically achieved peak viral load reduction three to seven days after the initial dose.

• The Immune Response Corp., of Carlsbad, Calif., said preliminary Phase II data suggested that both Remune and IR103, the company's first- and second-generation HIV vaccine candidates, stabilize CD4+ T-cell counts compared to placebo in HIV patients who have not started antiretroviral therapy. The 36-week data are from a yearlong safety and immunogenicity study expected to conclude in 2008.