• Antisense Pharma GmbH, of Regensburg, Germany, said the first colorectal carcinoma patients entered its Phase I/II study of AP 12009 in malignant tumors. So far, the trial also has enrolled patients with advanced pancreatic carcinoma and malignant melanoma Stage IV. The primary endpoint of the trial is assessment of the maximum tolerated dose and dose-limiting toxicity upon systemic treatment.

• Arena Pharmaceuticals Inc., of San Diego, initiated a Phase IIa trial of MK-0354, an orally administered candidate under development by Whitehouse Station, N.J.-based Merck & Co. Inc. for atherosclerosis and related disorders. The trial triggers a $4 million milestone payment to Arena under the research collaboration and license agreement for compounds targeting a G protein-coupled receptor. The trial is designed to evaluate MK-0354 in patients with dyslipidemia.

• Arginox Pharmaceuticals Inc., of Redwood City, Calif., said it has achieved a 50 percent patient enrollment target in its pivotal Phase III registration study of tilarginine acetate injection in patients experiencing cardiogenic shock following reperfusion for acute myocardial infarction. The Triumph trial is evaluating the safety and efficacy of tilarginine in reducing 30-day mortality in 658 cardiogenic shock patients at more than 130 sites in the U.S., Canada and Europe. An independent data safety monitoring board will meet this summer to review results from the first 50 percent of enrolled patients.

• CardioVascular BioTherapeutics Inc., of Las Vegas, achieved a safety milestone in its Phase I trial of its lead drug candidate formulated with Cardio Vascu-Grow in patients with severe coronary artery disease. The trial included three escalating dose groups, and no significant unexpected adverse events were attributable to CVBT's product. The company plans to move forward with a Phase II trial to evaluate safety and efficacy of the product in a larger population of patients with inoperable coronary heart disease.

• DeCode Genetics Inc., of Reykjavik, Iceland, started patient enrollment in the pivotal Phase III trial for DG031, the company's lead compound for the prevention of heart attack. The trial will be randomized, double-blind, placebo-controlled and will enroll 3,400 patients with a history of recent heart attack. It will evaluate a dose of 500 mg of DG031 twice daily, and the primary endpoint is a composite of reduction in fatal and non-fatal heart attack and stroke, hospitalization for unstable angina and the need for urgent revascularization.

• Neotropix Inc., of Malvern, Pa., said the FDA gave its nod to an investigational new drug application for Seneca Valley Virus (SVV-001). A dose-escalating Phase I study will determine if SVV-001 can be systemically administered safely to patients with certain types of advanced neuroendocrine cancers, including small-cell lung cancer. The study also will examine the distribution of the virus in the body, the elimination of it from the body, the immune response to the virus and whether it affects the patients' tumors.

• Speedel Group, of Basel, Switzerland, said Phase III data confirm the robust efficacy and safety profile of SPP100 (rasilez) both as a monotherapy and in co-administration with the diuretic hydrochlorothiazide. It is the first-in-class once-daily oral renin inhibitor that Speedel developed through Phase I and II trials before Novartis AG, also of Basel, exercised its license-back option in 2002. The FDA accepted Novartis' new drug application for SPP100 in April for hypertension. The Phase III data were presented at the 21st annual scientific meeting and exposition of the American Society of Hypertension.

• Targacept Inc., of Winston-Salem, N.C., reported positive results from its Phase II trial of TC-1734 in age-associated memory impairment. The drug achieved statistically significant results on all three endpoints - measured by a change in baseline on the Power of Attention and Episodic Memory factors from the Cognitive Drug Research test battery, and composite score on subject global impression. TC-1734, a selective alpha4 beta2 neuronal nicotinic receptor agonist, is intended for development in Alzheimer's disease and cognitive deficits in schizophrenia and is being developed with London-based AstraZeneca plc.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., started a Phase I study with VX-770, an oral drug candidate that specifically targets a key mechanism underlying cystic fibrosis. The study will evaluate the safety, tolerability and pharmacokinetics of escalating single and multiple doses of VX-770 in healthy volunteers, and also will evaluate single doses of VX-770 in patients with CF. The study is expected to enroll more than 50 patients.