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News

Resten-MP delivery system completes patient enrollment of phase II of the Appraisal clinical trial

Cook : 09 July, 2007  (New Product)
The target patient enrollment and six-month follow-up data in phase II of the Appraisal clinical trial of the Resten-MP delivery system has been completed.
The trial, currently being held in Germany, was designed to study the effect of Resten-MP in the prevention of cardiovascular restenosis when used in conjunction with the placement of one or more bare metal stents.

'The latest clinical trial results are really promising. We believe that the Resten-MP delivery system eliminates the potential long-term problems associated with the current drug eluting Stent systems available to physicians and patients,' said Stefan Sack, MD, principal investigator at the University of Essen in Germany, principal investigative centre. 'We would like to thank the many patients, clinicians and research coordinators who participated in this trial and look forward to sharing a clinical update at the Transcatheter Cardiovascular Therapeutics (TCT) Meeting in October 2007 in Washington, DC, USA.'

Phase II of the multi-centre, non-randomised Appraisal study examined 52 patients who suffer from symptomatic ischemic heart disease and the stenotic lesion of native coronary arteries. In the study, clinicians administered Resten-MP within 60 minutes of successful Stent placement in the coronary artery, and again 24 hours later via slow-push intravenous administration. Resten-MP (AVI-4126), developed by AVI BioPharma, (AVII) and licensed by Cook Medical, is a third-generation antisense agent that targets the key regulatory gene involved in cardiovascular restenosis.

'We are looking forward to the presentation at the TCT this October. Our plan is to invest the necessary resources to commercialise AVI's Neugene technology as quickly as possible for the cardiology market,' said Joseph B Horn, president of Global Therapeutics, a Cook Medical company. 'Our partnership with AVI BioPharma has proven to be a successful collaboration as we seek alternative Drug delivery methods to improve the efficacy shown by drug-eluting stents.'
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