• Boston Scientific(Natick, Massachusetts) reported one-year data from its carotid artery stenting (CAS) clinical trial, BEACH. The study evaluates the effectiveness of stenting with embolic protection for patients who are at high-risk for carotid endarterectomy. Results were presented at the 14th annual Peripheral Angioplasty and All That Jazz meeting in New Orleans. The BEACH trial was designed to evaluate Boston Sci’s Carotid Wallstent Monorail Endoprosthesis and the FilterWire EX and EZ Embolic Protection Systems. It is a prospective, non-randomized, single-arm clinical trial that enrolled 747 patients at 47 U.S. sites, with 480 patients in the pivotal phase of the trial. The trial also enrolled 189 patients in a “roll-in” group and 78 patients in a bilateral registry. The trial has a composite primary endpoint of cumulative mortality and morbidity through one year, consisting of stroke, death and myocardial infarction (MI). Christopher White, MD, co-principal investigator of the trial and director of the Ochsner Heart and Vascular Institute and chairman of Ochsner’s department of cardiology, presented data showing a composite one-year endpoint of 9.1%. The breakdown of patients experiencing one or more events is: stroke, 7%; death, 3.2%; and MI, 1.1%. The roll-in group – in which physicians trained on the Boston Scientific devices before entering the pivotal group – reported an event rate of 8.7%. The bilateral group – consisting of patients with carotid artery disease requiring treatment in both carotid arteries – reported an event rate of 7.1%. The BEACH results suggest that CAS may ultimately be a viable treatment option for this high-risk population.

• Neoprobe (Dublin, Ohio) said that its subsidiary, Cira Biosciences, has received an independent technology assessment report on its activated cellular therapy (ACT) technology. The assessment was performed by the Battelle Memorial Institute (Columbus, Ohio) to review the cell processing procedures and manufacturing processes used by Cira Biosciences in earlier ACT clinical trials that provided positive clinical results. The Battelle report indicates that the ACT cell processing technology would be commercially feasible and reproducible with Cira’s implementation of the recommended Battelle process and procedure development initiatives. Battelle also identified a number of laboratory processing and handling procedures that could be consolidated thereby improving cell-processing efficiency and potentially reducing processing costs. Cira’s scientific advisors recommended that it would be appropriate to initiate a Phase II study under Neoprobe’s corporate investigational new drug application for end-stage colorectal cancer and to initiate a separate Phase I study for pancreatic cancer. In addition, Cira’s viral disease consultants have recommended that the technology should be evaluated in African-American hepatitis C patients because of the significant difference in treatment efficacy rates of currently used treatment methods between African-American and Caucasian patients. Finally, the clinicians who evaluated the technology in patients with chronic fatigue syndrome are seeking institutional clearances to complete a five-year follow-up on the treated patients who responded to the ACT therapy.