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BY OUR PHARMA CORRESPONDENT
12th August 2005: Corautus Genetics Inc will continue its studies with the angina drug.
The independent data monitoring committee (DMC) recommended, as the result of its second scheduled interim safety analysis, the continuation of GENASIS (Genetic Angiogenic Stimulation Investigational Study), Corautus' phase IIb clinical trial to evaluate the safety and efficacy of Vascular Endothelial Growth Factor-2 (VEGF-2), for the treatment of patients with severe angina, the company announced in a press statement.
This planned interim safety analysis was conducted after the first 115 patients were treated in the trial. This was the second positive interim safety analysis recommendation by the DMC. The DMC, a group of independent physicians and a statistician, was established to monitor the safety data from the trial. Based on their review of the available data, the DMC recommended continuing the GENASIS trial.
The GENASIS trial is designed to test the efficacy and safety of VEGF-2, delivered into the heart via Boston Scientific Corporations' Stiletto catheter system. Corautus developed a well-defined schedule to deliver data for the first two interim safety analyses to the independent DMC and it anticipated the third DMC analysis and review after approximately 250 patients are treated, the statement said.
GENASIS is a randomized, double-blinded, dose-ranging and placebo- controlled phase IIb clinical trial, which will enroll 404 patients with Class III or IV angina that are not suitable candidates for traditional revascularization procedures. The GENASIS trial is being conducted in approximately 30 leading cardiac medical centres throughout the United States. Completion of enrolment is expected in the first quarter of 2006.
In the GENASIS trial, defined doses of VEGF-2 in the form of "naked" plasmid DNA, a non-viral delivery vector, are delivered to diseased heart muscle tissue via the Boston Scientific Corporation’s Stiletto endocardial direct injection catheter system. The injection procedure is performed by a cardiologist in a standard cardiac catheterization laboratory.
VEGF-2 is a naturally occurring growth factor that is believed to promote the development of supplemental collateral blood vessels, a process known as therapeutic angiogenesis. Once administered, the DNA plasmid appears to be taken up and expressed by myocardium near the injection site. Inside the cell, the DNA plasmid then enters the nucleus of the cell without a requirement of incorporation into the genomic DNA. The phase IIb clinical trial expects to see the effect of the expression of DNA-encoded VEGF-2, which in turn stimulates the growth of new blood vessels by promoting the migration and proliferation of endothelial cells in the heart.
The American Heart Association estimates that more than 6.4 million individuals in the United States are classified as having angina pectoris. Of these individuals with angina pectoris, approximately 150,000 to 250,000 annually are diagnosed as having refractory coronary artery disease and cannot be successfully treated with conventional cardiovascular therapies.
Corautus Genetics Inc. is a clinical-stage biopharmaceutical company developing gene transfer therapy products for the treatment of cardiovascular (severe angina) and peripheral vascular disease.
BY OUR PHARMA CORRESPONDENT
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