• Amira Pharmaceuticals Inc., of San Diego, reported positive data from a Phase I trial of AM103, its lead compound, showing that a single dose of the drug achieves highly significant inhibition of leukotriene synthesis. AM103 is an oral, next-generation inhibitor of the 5-lipoxygenase-activating protein (FLAP) and has demonstrated potential in asthma and cardiovascular disease by preventing the synthesis of leukotrienes, biological compounds that lead to inflammation. Final data from the study are expected in the fourth quarter.

• Genzyme Corp., of Cambridge, Mass., reported positive results from its Study of the Treatment of Articular Repair (STAR) on the safety and effectiveness of Carticel (autologous cultured chondrocytes) in patients who had an inadequate response to a previous knee cartilage repair procedure. The study data showed significant reductions in knee pain, as well as improvements in function, including recreational and sports activities. Carticel is an autologous cell therapy used for the repair of symptomatic cartilage lesions on the thigh bone portion of the knee caused by acute or repetitive trauma in patients who have had an inadequate response to a prior cartilage repair procedure. Data were reported at the American Orthopaedic Society for Sports Medicine meeting in Calgary, Alberta.

• Hollis-Eden Pharmaceuticals Inc., of San Diego, reported that initial results from its ongoing single-dose Phase I study of HE3286 for the treatment of metabolic disorders demonstrated the compound is orally bioavailable in humans, with significant drug concentrations detected in the blood at the lowest dose tested. All doses (10 mg to 100 mg) appear to be safe and well tolerated. Some preclinical data, being published by the New York Academy of Sciences, demonstrated that the orally bioavailable small-molecule adrenal steroid hormone produced a statistically significant reduction in disease in a rodent model of arthritis. The company plans to file an investigational new drug application in the third quarter for treating inflammatory conditions. A Phase I/II clinical trial is planned in rheumatoid arthritis patients for the fourth quarter of 2007, as is a separate multidose Phase I study of HE3286 for metabolic disorders under the company's open IND.

• Interleukin Genetics Inc., of Waltham, Mass., completed patient enrollment in clinical studies in Japan and China as part of its preparation for the anticipated launch of genetic tests in Asian markets in 2009. About 1,300 subjects with cardiovascular disease or who are healthy controls have entered the China study, and the other trial finished enrolling 400 subjects in the Tokyo study, which is focused on genetic variations, bone loss and osteoporosis in postmenopausal women. The trials are designed to investigate the role of genetics in determining individual risks for early cardiovascular disease events and for bone loss and related fractures in specific populations. Interleukin expects to complete data collection for both studies by the end of August.

• LifeCycle Pharma A/S, of Horsholm, Denmark, said it will initiate a Phase II trial of LCP-AtorFen, a fixed-dose combination of atorvastatin and fenofibrate, to treat high cholesterol levels. The 200-patient study will compare LCP-AtorFen with Lipitor (atorvastatin, Pfizer Inc.) and Tricor (fenofibrate, Abbott) and will address three primary cardiovascular risk factors: low density lipoprotein cholesterol, high density lipoprotein cholesterol and triglycerides. Data from the study are expected next year.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., has begun a randomized, multicenter Phase III trial to determine the most effective Velcade-based combination therapy with approved agents for the treatment of newly diagnosed multiple myeloma patients, ineligible for stem cell transplantation. The trial, named UPFRONT, will compare three Velcade-based therapies: Velcade and dexamethasone; Velcade, thalidomide and dexamethasone; and Velcade, melphalan and prednisone. The primary endpoint of the trial is progression-free survival with secondary endpoints including duration of response, overall survival and overall safety/tolerability. Target enrollment for the trial is up to 500 patients, and participants will remain in the trial on treatment for up to one year.

• TransPharma Medical Ltd., of Lod, Israel, reported promising results of its Phase I clinical trial testing the safety and pharmacokinetic profile of ViaDerm-hPTH (1-34) for the treatment of osteoporosis. The seven-day, repeated-dose application, parallel group study was conducted on 48 healthy, elderly, post-menopausal women to evaluate the safety and tolerability of ascending multiple doses of hPTH (1-34) patches and to compare the pharmacokinetic profiles of the transdermally delivered doses of hPTH (1-34) with that of FORTEO® administered subcutaneously. Once-daily transdermal delivery of all doses showed a safety profile similar to the Forteo subcutaneous injection. All safety parameters were within the normal range and the all doses were well tolerated.

• XOMA Ltd., of Berkeley, Calif., has initiated Phase I clinical testing of product candidate XOMA 052, a monoclonal antibody targeting Interleukin-1 beta (IL-1 beta), in patients with Type II diabetes. IL-1, which plays a role in multiple inflammatory diseases, has been implicated in the pathogenesis of diabetes through the destruction of the pancreatic islet cells that produce insulin. The U.S.-based study, designed to assess the safety and pharmacokinetics of XOMA 052, will enroll up to 72 subjects with Type II diabetes. XOMA plans to initiate a European-based Phase I clinical trial of XOMA 052 in Type II diabetes patients later in 2007.