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This Phase II study will assess the safety and effectiveness of 3 dose levels of FGF-1141 when administered via the NOGA MyoStar® injection catheter to subjects on optimal medical therapy for chronic angina. In general, these patients are not good candidates for percutaneous interventional or surgical therapy. The Phase I study administered FGF-1141 via a mini-thoracotomy to the myocardium. The Phase II study will utilize an injection catheter to deliver the FGF-1141 to essentially the same region in the heart wall, but will not necessitate a surgical intervention.

In addition, the use of a catheter in the Phase II study will allow a placebo dose to be studied. Efficacy will be measured by evidence of improved myocardial perfusion and function via exercise tolerance, SPECT scans, NOGA electromagnetic mapping, angiography and anginal questionnaires. In addition, each dose group will be compared for safety and tolerability through monitoring for serious adverse events (SAEs), laboratory and physical exams, electrocardiograms (ECGs) and ophthalmological exams.


 

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12/11/2008
CVBT Opens Two Additional Sites for Patient Enrollment for Phase II Heart Trial


11/25/2008
CVBT Doses First Patient in its Phase II Clinical Trial for Severe Coronary Heart Disease


11/13/2008
CVBT Closes Clinical Development Agreement for Coronary Heart Disease Drug Candidate


9/9/2008
CVBT Announces First Site to Begin Patient Enrollment for Its Phase II Heart Trial