Primate Model for Pharmaceutical Development

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DESCRIPTION (provided by applicant): Advances in molecular medicine and genomic research promise to produce exciting new strategies for the treatment of human diseases. One significant concern regarding preclinical research data is that the results may not be predictive of future clinical outcomes. Many differences in anatomy, physiology and pathological processes exist between animals and humans. The goal of our STTR proposal is to set up a novel preclinical research model in monkeys. This chronically instrumented, conscious monkey model will closely mimic the process of congestive heart failure observed in human patients, which is a leading cause of mortality and morbidity in the US. Clearly, this model will help not only to elucidate the mechanisms of the heart disease, but also will provide a system for the assessment of potential new interventions in man. Pharmacodynamic and pharmacokinetic studies, as well as safety and toxicology assessments also may be performed. The Phase I STTR project proved the hypothesis that combined myocardial infarction (MI) with rapid ventricular pacing can induce chronic myocardial ischemia leading to end stage heart failure in instrumented, conscious monkeys. The Phase II study will further characterize this model, particularly regarding the phenomenon of myocardial remolding, and may lead to the identification of genes involved in cardiac cell survival and death. To achieve the phase II goals, the study will use state-of-art, physiological, genomic and pathological experimental approaches in monkeys. This Phase II project will enable the new business venture, Vasade Biosciences, to provide a valuable commercial contract research service for the early preclinical needs of biotechnology and pharmaceutical companies.