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Ceftobiprole, a novel cephalosporin antibiotic from Johnson & Johnson Pharmaceutical Research and Development, Raritan, NJ, showed effectiveness in phase 3 clinical trials against complicated skin infections caused by potentially deadly bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). Data on the trials were presented in 2 posters at that 46th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy in San Francisco, CA.


In the first presentation, ceftobiprole demonstrated high clinical cure rates comparable to vancomycin in treating patients with complicated skin and skin structure infections (cSSSIs) due to Gram-positive bacteria, including MRSA. A second poster, describing the baseline pathogens seen in the cSSSI study, showed that ceftobiprole was microbiologically effective against a wide range of both Gram-positive and Gram-negative bacteria. Basilea Pharmaceutica, Ltd, Basel, Switzerland, is codeveloping the antibiotic.


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Theravance, Inc (San Francisco, CA), has announced results from its ATLAS 1 and ATLAS 2 studies assessing the safety and efficacy of televancin, a rapidly acting bactericidal injectable antibiotic with multiple mechanisms of action, in the treatment of complicated skin and skin structure infections caused by Gram-positive bacteria. The 2 large, multicenter, multinational, double-blind, randomized, phase 3 clinical studies enrolled and treated 1867 patients, 719 of whom were infected with MRSA. In the combined data from both studies in patients with MRSA, clinical cure rates, microbiologic eradication rates, and overall therapeutic response favored televancin over vancomycin. The most common adverse events reported in patients receiving televancin were taste disturbance, nausea, and vomiting. Less than 1% of these events were considered severe.


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Peripheral Arterial Disease

At the El Camino Hospital, Mountain View, CA, the first patient has been enrolled in the XCELL clinical trial, which is the first US study to evaluate Abbott Vascular's Xpert self-expanding stent (Abbott Vascular Devices, Abbott Park, IL) in blood vessels below the knee for the treatment of severe peripheral arterial disease (PAD). The study, which was cleared by the FDA, is sponsored by VIVA Physicians, Inc, and supported by a restricted educational grant from Abbott.


The patient was an 87-year-old man with leg pain at rest and gangrenous ulcers on his left foot. He has multiple health problems, including diabetes, and all of the arteries in his left calf were completely blocked. The procedure was successful in opening the most critical blockage below his knee and in restoring blood flow to his foot. The patient will return to the hospital at 1, 3, 6, and 12 months following the procedure for close monitoring of the stents. Ten health care centers are participating in the XCELL study, which expects to enroll 140 patients.


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Venous Leg Ulcers

OrCel bilayered cellular matrix, from Ortec International, Inc, New York, NY, healed more wounds and achieved 100% wound closure of those wounds sooner in comparison with the control group in a 12-week confirmatory trial.


The trial was designed to confirm the effectiveness of cryopreserved OrCel in the healing of difficult-to-heal venous leg ulcers in comparison with standard of care therapy. The company announced that statistical significance was achieved for the primary clinical end points of incidence of patients achieving 100% wound closure, as well as acceleration of wound closure with the OrCel-treated patients as early as the third week, which was maintained from week 5 through week 11 using the required FDA statistical approach.


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Wound Healing

Swiss-American Products, Inc., Dallas, TX, has reported results from a recent study on its Protease Technology-enhanced line of skin and wound care products. Laboratory and clinical testings indicate that Elta Protease Technology deactivates detrimental components that inhibit healing while preserving others needed to facilitate the healing process. The testings showed a significant reduction of harmful proteins found in nonhealing wounds, thus enhancing the environment for healing. A study conducted by the University of Florida, Gainesville, FL, on the product was presented at the Wound Healing Society annual meeting.


The protease blend is nonsteroidal, contains anesthetic or antihistamines, and is easily incorporated into various delivery formulations, according to the manufacturer.


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